TARIS Biomedical LLC

Patent Trials and Appeals Board

May 19, 2020

15633492 - (D) (P.T.A.B. May. 19, 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.
15/633,492 06/26/2017 Karen Danielle Daniel 29449-0366 4144
29052 7590 05/19/2020
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
CABRAL, ROBERT S
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
05/19/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KAREN DANIELLE DANIEL, BURLEIGH M. HUTCHINS,
CHERYL LARRIVEE-ELKINS, and HEEJIN LEE1
____________

Appeal 2019-005306
Application 15/633,492
Technology Center 1600
____________

Before DEBORAH KATZ, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies TARIS Biomedical LLC as the real
party-in-interest. App. Br. 2. Oral argument was heard on May 6, 2020, and
the transcript thereof is a part of the record on appeal.
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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–20. Specifically, claims 1–7, 9–17,
19, and 20 stand rejected as unpatentable under 35 U.S.C. § 103 as being
obvious over the combination of Politi et al. (US 2008/0111269 A1, May 15,
2008) (“Politi”), Peppas (US 2009/0317465 A1, December 24, 2009)
(“Peppas”), A.L. Rosa et al., Clinical Effectiveness of Lidocaine and
Benzocaine for Topical Anesthesia, 46 ANESTH. PROG. 97–99 (1999)
(“Rosa”), Pich et al. (US 4,797,287, January 10, 1989) (“Pich), Pryce Lewis
et al. (US 2003/0143268 A1, July 31, 2003) (“Pryce Lewis”), and Rothbard
et al. (US 2005/0192210 A1, September 1, 2005) (“Rothbard”).
Claims 8 and 18 stand rejected as unpatentable under 35 U.S.C. § 103
as being obvious over the combination of Politi, Peppas, Rosa, Pich, Pryce
Lewis, Rothbard, and T. Rhines, Non-Chromatographic Methods to Support
Stability Program, in HANDBOOK OF STABILITY TESTING IN
PHARMACEUTICAL DEVELOPMENT, REGULATIONS, METHODOLOGIES, AND
BEST PRACTICES (K. Huynh-Ba, ed.) 201, 215 (2009) (“Huynh-Ba”).
Claims 1–20 also stand provisionally rejected under the nonstatutory
doctrine of obviousness-type double patenting over claims 1–7 of copending
US Appl. Ser. No. 13/729,974 (the “’974 application”).2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

2 Appellant does not address this rejection in the Appeal Brief. We
consequently summarily affirm this rejection. See 37 C.F.R. § 41.37(c)(iv)
(“[A]ny arguments or authorities not included in the appeal brief will be
refused consideration by the Board for purposes of the present appeal”).
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NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to “[a] drug dosage in the form of a
solid tablet that is greater than 50% by weight of a local anesthetic agent.”
Abstr.

REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A solid drug unit comprising:

a drug in the form of a mini-tablet which is greater than
70% by weight [of] the drug, with the balance being at least one
excipient,

wherein the mini-tablet is cylindrical with flat end faces,
the length of the tablet exceeding its diameter so that the mini-
tablet has an aspect ratio of greater than 1:1, and

wherein the mini-tablet has a diameter from 1.0 mm to 3.2
mm and a length from 1.7 mm to 4.8 mm, such that the mini-
tablet is sized and shaped for insertion through the urethra of a
patient.

App. Br. 21.

ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are obvious over the combined
cited prior art. We address below the arguments raised by Appellant.

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A. Independent claims 1 and 113
Issue
Appellant argues that the Examiner erred by employing impermissible
hindsight analysis in forming the rejection and by not providing any
motivation to combine the references or establishing that a person of
ordinary skill in the art would have had a reasonable expectation of success.
App. Br. 6.

Analysis
The Examiner finds that Politi teaches “[a] granulate mass or tablet of
the invention may comprise at a minimum 1, 5, or 10 percent (weight) and at
a maximum 100, 95, 90, 80 or 70% of at least one active pharmaceutical
ingredient” Final Act. 8 (quoting Politi ¶ 107; see also ¶¶ 94–95). The
Examiner finds that Politi also teaches that “the method is applicable to a
large variety of solid powder substances, e.g.[,] APIs and excipients.” Id. at
9 (quoting Politi ¶ 27).
The Examiner finds that Pich teaches “cylindrical microtablets which
have a convex upper face and a convex lower face and whose cylinder
diameter and height independently of one another are each from 1.0 to 2.5
mm and the ratio of the said diameter to said height is from 1:0.5 to 1:1.5.”
Final Act. 9 (citing Pich Abstr.).
The Examiner finds that Pryce Lewis teaches uniaxially compressed
dosage forms such that:

3 Appellant does not argue claims 2–5, 8, 10–15, 18, or 20. We therefore
consider these claims as standing or falling with independent claims 1 and
11, from which they depend.
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Any dosage form would have a geometric center, and
concentration of one or more components could be a function of
distance from the geometric center of the dosage form, either by
use of a dosage form having spherical symmetry or by use of a
dosage form which lacks spherical symmetry but has a
reasonably simple shape such as a circular cylinder or
rectangular parallelepiped of not too extreme aspect ratio.

Final Act.. 9 (quoting Pryce Lewis ¶ 89). In particular, the Examiner finds,
Pryce Lewis teaches a dosage form having a cylindrical shape with flat ends.
Id. (citing Pryce Lewis claim 24).
The Examiner finds that Rothbard teaches compositions and methods
for treating diseases and, specifically, that “drugs may be inserted into the
urethra at the tip of the penis.” Final Act. 10 (citing Rothbard ¶ 100). The
Examiner finds that Rothbard further teaches that: “[i]nserts into the urethra
may be in the form of a tablet, suppository or other pill that may include
biodegradable and/or nonbiodegradeable materials.” Id. (quoting Rothbard
¶ 140).
The Examiner finds that Peppas teaches mini-tablets comprising local
anesthetics, and discloses benzocaine as an example, and that Rosa teaches
that lidocaine and benzocaine were equally efficient in reducing pain. Final
Act. 9 (citing Peppas ¶¶ 67, 92; Rosa Abstr.).
The Examiner concludes that Appellant’s claimed invention would
have been prima facie obvious to a person of ordinary skill in the art at the
time of the invention. Final Act. 10. Specifically, the Examiner concludes
that a skilled artisan would have been motivated to formulate a tablet small
enough for insertion through the urethra with a high load of anesthetic agent,
by the combined teaching and suggestions of Politi, Peppas, Rosa, and
Rothbard. Id. The Examiner reasons that Politi teaches how to prepare
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high-load tablets, and Peppas and Rothbard teach that there would have been
a reasonable expectation of success that such high-load mini-tablets of
anesthetic agents, such as benzocaine were not only obtainable, but could be
used, intended, or configured for insertion through the urethra. Id. The
Examiner also reasons that a skilled artisan would have been motivated to
modify the teachings of Politi and Peppas to incorporate lidocaine as a
simple substitution for benzocaine to obtain a predictable result in view of
Rosa’s teaching that benzocaine and lidocaine are functional equivalents.
Id.
Appellant acknowledges that Politi teaches that its oral dosage forms
may contain from 1 to 100 weight percent drug. App. Br. 7 (citing Politi
¶ 107). However, argues Appellant, Politi provides no guidance regarding
overcoming the known challenges with formulating drug compositions in the
form of mini-tablets, let alone how one can achieve a mini-tablet containing
greater than 70 percent by weight drug. Id.
Turning to Peppas, Appellant argues that, contrary to the Examiner’s
findings and prior to the present invention, it was believed in the art that to
achieve a mini-tablet form, the composition can contain at most 42.8 to 50
weight percent drug. App. Br. 7 (citing Peppas ¶ 41). According to
Appellant, Peppas teaches that, to formulate its mini-tablets, the excipient
content must be at least 50 weight percent. Id. As such, Appellant contends,
a person of ordinary skill in the art, reading Politi and Peppas as a whole,
would have understood that a mini-tablet formulation should contain at most
50 weight percent drug to achieve desired structural and drug release profile
characteristics of the mini-tablet. Id. Therefore, Appellant alleges, absent
improper hindsight using Appellant’s Specification and claims as a
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blueprint, a person of ordinary skill in the art would not have been motivated
to disregard the teachings of Peppas and arrive at the claimed mini-tablets.
Id. Appellant agrees with the Examiner’s finding that Peppas teaches
various layers of various drug content levels; however, Appellant maintains,
the maximum drug content of any individual layer (and therefore the
maximum possible drug content of the overall tablet) is 42.8 to 50 weight
percent. Id. at 8.
Appellant asserts that, unlike Peppas’ tablets, which contain at most
50 percent drug:
[T]he [claimed] drug tablets may constitute mostly drug and little or no
excipients, so the drug tablets contain a large amount of drug
considering the tablet size.… Instead, the excipients present in the drug
tablets may be present primarily or completely to facilitate the tableting
process. Thus, the device may provide a very high drug payload on a
volume or weight basis, such as at least 50 wt % drug, in contrast to
known intravesical devices.

App. Br. 9 (quoting Spec. 6). Appellant points to Examples 5–7 of the
Specification as demonstrating the unpredictability and difficulties
associated with tableting high amounts drug into mini-tablets. Id.
Appellant notes that the Examiner relies upon Pich and Pryce Lewis
as teaching the claimed mini-tablet dimensions and geometry; however,
Appellant argues, the Examiner’s rejection relies on a misinterpretation of
Pryce Lewis and disregards an alleged teaching away from Appellant’s
claimed tablets by Pich. App. Br. 9.
Appellant argues that the Examiner relies upon Pryce Lewis as
teaching an oral dosage form having a shape that is cylindrical with flat ends
with “dimensions of 1.78 mm in height (or length) and 11.17 in diameter.”
App. Br. 9 (citing Pryce Lewis ¶ 98). However, Appellant argues, the aspect
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ratio taught by Pryce Lewis is the opposite of the claimed aspect ratio;
Appellant contends that Pryce Lewis teaches away from the claimed aspect
ratio, and instead teaches aspect ratios significantly less than 1:1. Id.
Appellant asserts that Pryce Lewis teaches tablets having a wafer shape in
which the diameter is at least twice as large as the length: the examples cited
by the Examiner, argues Appellant, teach a diameter that is over six times at
large as the length (i.e., an aspect ratio of about 1:6). Id. at 9–10 (citing
Pryce Lewis, Table 1, ¶¶ 98, 100). According to Appellant, not only does
Pryce Lewis fail to teach or suggest the claimed tablet diameter of 1.0 mm to
3.2 mm, instead teaching that the diameter should be at least three times the
claimed diameter, Pryce Lewis further teaches that the diameter must exceed
the length of the tablet, contrary to the claimed drug units. Id.
Appellant argues further that Pryce Lewis’ use of the phrase “not too
extreme aspect ratio” refers to the opposite aspect ratio than what is claimed
by Appellant. App. Br. 10. Therefore, Appellant argues, the Examiner’s
reliance upon the Pryce Lewis is not appropriate because, Appellant
contends, Pryce Lewis teaches away from the claimed aspect ratio. Id.
According to Appellant, the passage cited by the Examiner that recites that
the dosage form can be in the form of a circular cylinder or a “rectangular
parallelepiped of not too extreme aspect ratio” means that the dosage form
could have a face that is rectangular in shape with the length of the rectangle
being similar to its width, i.e., the rectangle face is close in dimensions to a
circle. Id. Appellant asserts that this passage has nothing to do with the
relative height of a rectangular-faced tablet to the length or width
dimensions of the face, as found by the Examiner. Id. Appellant asserts that
the relatively large, wafer-shaped oral dosage forms of Lewis would not
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have provided any guidance to a person of ordinary skill in the art looking to
design a tablet for insertion through the urethra. Id.
Appellant next argues that Pich is cited by the Examiner as teaching
“cylindrical microtablets which have a convex upper face and a convex
lower face and whose cylinder diameter and height independently of one
another are each from 1.0 to 2.5 mm and the ratio of the said diameter to
height is from 1:0.5 to 1:1.15.” App. Br. 11 (citing Pich col. 2, ll. 8–14).
Appellant contends that Pich teaches that the aspect ratio may be such that
the diameter is greater than or less than the height, but requires that the
tablets have convex faces with particular radii of curvature. Id. Appellant
contends that Pich teaches this is necessary, because when “larger radii flat
upper and lower faces (infinite radius of curvature) are approached, with the
disadvantage that the edges present problems during coating and a
susceptible to mechanical damage.” Id. (citing Pich col. 2, ll. 40–48).
Appellant asserts that Pich therefore expressly teaches away from tablets
having flat faces, as claimed by Appellant, and suggests, rather, that
cylindrical tablets having flat faces should be avoided due to, problems with
coating and susceptibility to mechanical damage. Id.
Appellant points to paragraph [0037] of the Specification, which
discloses that “the drug tablets are substantially smaller than conventional
drug tablets, and unlike conventional tablets that tend to be squat in shape,
the drug tablets may be tall and elongated and/or may have flat, rather than
convex, end faces.” App. Br. 12. Appellant asserts that it has discovered
that the difficulties discussed by Pich may be overcome by formulating
tablets having the particular claimed dimensions and compositions. Id.
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Therefore, Appellant contends, a person of ordinary skill in the art,
reading Pich, would have had no reason to modify the tablet geometry to
have the claimed aspect ratio in combination with flat or non-convex faces,
at least because Pich expressly teaches that such tablets would have
manufacturing and stability issues. Id.
Appellant disputes the Examiner’s reasoning that Appellant
misunderstands Pich’s teaching of convex faces, and particularly the
Examiner’s finding that “Pich is referring to upper and lower face being
convex and not end faces.” App. Br. 12 (quoting Final Act. 4). Appellant
disagrees, contending that Pich teaches cylindrical microtablets having a
face at each end of the cylindrical body. Id. (citing Pich Fig.). Appellant
contends that the “upper and lower faces” of the cylindrical microtablet of
Pich are the “end faces” of its cylindrical body.
Appellant contends that, contrary to the Examiner’s findings, Pich
does not merely describe convex end faces in more favorable language or as
one alternative; Pich expressly teaches the use of non-convex faces as
disadvantageous during coating and use due to mechanical damage, as
described above. App. Br. 13 (citing Pich col. 2, ll. 40–48). Appellant
contends that Pich therefore expressly teaches away from flat end faces, as
required by Appellant’s claims. Id.
With respect to Rothbard, Appellant notes the Examiner’s findings
that Rothbard teaches: (1) “drugs may be inserted into the urethra at the tip
of the penis”; (2) “Inserts into the urethra may be in the form of a tablet,
suppository or other pill that may include biodegradable and/or
nonbiodegradable materials.” App. Br. 14 (quoting Final Act. 10 (citing
Rothbard ¶¶ 10, 140). However, Appellant argues, Rothbard neither teaches
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nor suggests overcoming the known challenges associated with formulating
drug compositions in the form of mini-tablets, let alone how one can achieve
a mini-tablet containing an active agent at greater than 70% by weight. Id.
Furthermore, Appellant argues, Rothbard fails to teach or suggest any reason
why one would have been “motivated to prepare or formulate a tablet small
enough for insertion through the urethra with a high load of anesthetic
agent” which, Appellant argues, is the cornerstone of the Examiner’s
obviousness rejection. Id.
We are not persuaded by Appellant’s arguments. As an initial matter:
“[O]ne cannot show non-obviousness by attacking references individually
where … the rejections are based on combinations of references.” In re
Keller, 642 F.2d 413, 426 (C.C.P.A. 1981). Rather:
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the
art.

Id. at 425.
Specifically, Politi teaches that it is technically feasible to produce
A granulate mass or tablet of the present invention […] typically
compris[ing] at minimum 1, 5 … (weight) and at maximum 100,
95, 90, 80 or 70% of at least one active pharmaceutical
ingredient. In some embodiments said powder contains an
amount of active pharmaceutical ingredient of at least 60% e.g.[,]
at least 80%. The granulate mass or tablet may further comprise
at minimum 5, 10, 20 or 30% (weight) and at maximum 99, 95
or 90% of at least one excipient, e.g.[,] long-chain polymer e.g.[,]
starch or cellulose.

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Politi ¶ 107. Politi further teaches, with respect to the active pharmaceutical
ingredient (“API”) in its compositions:
The method of the present invention may thus be applicable to
producing granules and tablets of the invention from material
comprising APIs of one or multiple classes of APIs, the classes
including for example antipyretics, analgesics, … and other
orally administered agents. APIs can be used singly or two or
more of them can be used in combination.

Id. at ¶ 121 (emphasis added). We acknowledge that Politi is directed, in
this instance, to orally administered agents, but Politi nevertheless teaches
that it is technically feasible to synthesize a granulate mass or tablet
containing “greater than 70% by weight [of] the drug, with the balance being
at least one excipient,” as recited in the claims. Thus, the formulation can be
tailored to the intended application.
Appellant repeatedly asserts that manufacturing such a composition
poses problems that would have discouraged a skilled artisan. See, e.g.,
App. Br. 9 (citing Ex. 5–7). We do not find this argument persuasive. First,
Appellant points to no objective evidence of record to demonstrate that such
technical difficulties would have been encountered by a person of ordinary
skill in the art, despite the express teachings of Politi. Furthermore, although
Examples 5 and 6 demonstrate some difficulties in manufacturing a tablet
comprising either 95 or 100 wt% lidocaine (see Spec. Table 2) or
approximately 90% lidocaine (see id., Table 3), Appellant’s Examples do
not teach that such difficulties were present across the claimed range of
active agent, i.e., greater than 70%. Furthermore, Example 7 of the
Specification discloses that:
Mini-tablets were made from various different drugs. In a first
test, mini-tablets were made from lidocaine (base).… Each
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tableting test produced mini-tablets successfully. The mini-
tablets had a diameter of about 1.5 mm and a length of about 2
mm. No excipients were added to any of the tableted
compositions.

Spec. 64. Appellant’s Specification thus discloses that mini-tablets
containing 100% lidocaine (i.e., greater than 70% drug) could be
successfully manufactured.
With respect to Peppas, we agree with the Examiner that the reference
teaches mini-tablets that can contain local anesthetic agents, including, e.g.,
benzocaine. See Peppas ¶¶ 67, 92. Appellant argues that the reference
teaches limits upon the active agent in a mini-tablet of 50%. We
acknowledge that Peppas teaches such limits, for example, Peppas teaches
that:
FIG. 1 shows a pharmaceutical composition 2 with at least 7
layers. The first layer 4 at has a mass ratio of drug (D) to polymer
(P) of D/P of between about 0.75 and about 1.00, which
corresponds to about 42.8 to about 50 wt % of drug. The first
layer 4 of this composition can further include any drug or other
active agent that can be granulated with pharmaceutical
excipients….

Peppas ¶ 41; see also ¶¶ 42–44.
However, in an obviousness analysis, we are required to read prior art
references as a whole. See In re Enhanced Sec. Research, LLC, 739 F.3d
1347, 1355 (Fed. Cir. 2014). We find that, when read in the context of
Peppas’ invention, it is evident that the limits described for the layers of
Peppas’ mini-tablets are not absolute limits for all mini-tablet formulations.
Peppas is specifically directed to “compositions that deliver one or more
active agents with a substantially constant or zero order release profile.”
Peppas ¶ 11. Peppas teaches that these “tablets can be prepared with
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intermediate drug-free layers, thus achieving one or more intermittent
release at substantially constant rates followed by no release.” Id.
In other words, Peppas teaches that the layered structures of its
compositions, and the component active ingredients of the layers, are
directly related to the drug delivery profile of the claimed mini-tablets.
Appellant’s claims do not expressly recite, or inherently claim, any such
delivery profile, and we are therefore not persuaded by Appellant’s
argument that Peppas teaches or suggests an upper limit on the amount of
the drug that can be incorporated into the mini-tablet under any
circumstances.
Pryce Lewis teaches that:
Any dosage form would have a geometric center, and
concentration of one or more components could be a function of
distance from the geometric center of the dosage form, either by
use of a dosage form having spherical symmetry or by use of a
dosage form which lacks spherical symmetry but has a
reasonably simple shape such as a circular cylinder or
rectangular parallelepiped of not too extreme aspect ratio.

Pryce Lewis ¶ 89 (emphasis added). With respect to the circular cylinder
mentioned in the quoted passage, Pryce Lewis teaches that:
In general, a dosage form and corresponding article such as a
3DP printed article may be cylindrical with either flat or rounded
top and bottom surfaces, or rectangular prismatic with either fiat
or rounded surfaces, elliptical prismatic with either flat or
rounded surfaces, ellipsoidal, spherical, or could have any
general shape of cross-section and any general shape of end or
cap.

Id. at ¶ 33 (emphasis added); see also id. at claim 24 (“The dosage form of
claim 20 wherein the dosage form has a shape selected from the group
consisting of: cylindrical with flat ends….”).
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Appellant’s claim 1 further recites, in relevant part: “[T]he length of
the tablet exceeding its diameter so that the mini-tablet has an aspect ratio of
greater than 1:1.”4 Claim 1 also recites “wherein the mini-tablet has a
diameter from 1.0 mm to 3.2 mm and a length from 1.7 mm to 4.8 mm, such
that the mini-tablet is sized and shaped for insertion through the urethra of a
patient.”
Pich is directed to:
Cylindrical microtablets which have a convex upper face and a
convex lower face and whose cylinder diameter and height
independently of one another are each from 1.0 to 2.5 mm and
the ratio of the said diameter to said height is from 1:0.5 to 1:1.5,
and a process for their preparation.

Pich Abstr. Adopting Appellant’s definition5 of the term “aspect ratio,” Pich
thus teaches cylindrical microtablets with an aspect ratio of 0.5:1 to 1.5:1,
the latter falling within claimed range of aspect ratios and also teaches
absolute dimensions of height and diameter that are within the claimed
ranges. Although Pich teaches that its cylindrical microtablets are convex at

4 We note here that aspect ratio is conventionally expressed as the ratio of
the width of an object to its height, i.e., width:height. See, e.g., Aspect
Ratio, available at: https://techterms.com/definition/aspect_ratio (last
visited May 6, 2020). Appellant’s Specification, however, defines the
claim term “aspect ratio” thus: “[E]ach drug unit may have a length that
exceeds its width, meaning an aspect ratio of height:width that is greater
than 1:1.” Spec. 27. We therefore adopt Appellant’s definition for the
purposes of this analysis. See Phillips v. AWH Corp., 415 F.3d 1303, 1319
(Fed. Cir. 2005) (holding that: “Appellants may act as their own
lexicographers as long as they have clearly set forth an explicit definition
of the term”).

5 See id.
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either end, Pryce Lewis teaches that capsules can be either convex or flat at
either end.
Appellant argues that Pich, by teaching only convex ends to its
capsules, expressly teaches away from flat end faces, as required by
Appellant’s claims. See App. Br. 11. Specifically, Appellant points to
Pich’s teaching that “the edges present problems during coating and a
susceptible to mechanical damage.” Id. (citing Pich col. 2, ll. 40–48).
We disagree that this constitutes a teaching away from Appellant’s
claimed invention. A “teaching away” requires a reference to actually
criticize, discredit, or otherwise discourage the claimed solution, such that “a
person of ordinary skill, upon reading the reference, would be discouraged
from following the path set out in the reference, or would be led in a
direction divergent from the path that was taken by the applicant.” In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004); In re Gurley, 27 F.3d 551,
553 (Fed. Cir. 1994). Pich teaches:
The radius of curvature r of the convex upper and lower faces of
the cylindrical microtablet is from 0.6 to 1.5 times, preferably
from 0.7 to 0.9 times, the diameter of the cylinder. With smaller
radii of curvature (a spherical shape), the tools do not withstand
the pressure required, while with larger radii [of curvature] flat
upper and lower faces (infinite radius of curvature) are
approached, with the disadvantage that the edges present
problems during coating and are susceptible to mechanical
damage.

Pich col. 2, ll. 40–48. However, Pich teaches that its microtablets are made
via a specific, specialized and novel tableting presses, which is what
presented issues in forming tablets without curved ends. Id. at 24–31. Pryce
Lewis teaches alternative methods of making cylindrical capsules with flat
ends i.e., three-dimensional printing. See Pryce Lewis ¶ 33. Appellant’s
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claims do not recite a specific method of synthesizing the claimed
composition, and Appellant adduces no evidence that the methods of Pryce
Lewis would not have been known or available to a skilled artisan to achieve
the claimed invention.
Finally, Rothbard teaches:
Solid inserts for localized delivery (e.g., to the eye, vagina,
rectum and penis) may also be employed. Such inserts will be
in suitable form for the target area to be inserted.… Inserts into
the urethra may be in the form of a tablet, suppository or other
pill that may include biodegradeable and/or nonbiodegradeable
materials.

Rothbard ¶ 140. Rothbard also teaches that such inserts can include
anesthetic agents. Id. at ¶ 123.
To summarize, Politi teaches that solid drug tablet compositions can
include 70% by weight or greater active of the active agent, and Peppas
teaches solid drug compositions that are mini-tablets that can include
anesthetic agents. Pryce Lewis teaches cylindrical mini-tablets with flat
ends, and Pich teaches cylindrical mini-tablets of the dimensions claimed by
Appellant. Rothbard teaches that solid drug compositions of appropriate
size and design can be inserted in the urethra and may include anesthetic
agents.
We agree with the Examiner that, for the reasons we have explained, a
person of ordinary skill in the art, designing a solid drug composition that
could be inserted into the urethra for therapeutic reasons, would look to the
teachings of the combined cited prior art to produce the claimed invention.
We also agree that a skilled artisan would have had a reasonable expectation
of success in combining the references, the teachings of which are
complementary and overlapping. See KSR Int’l Co. v. Teleflex Inc., 550
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U.S. 398, 416 (2007) (holding that “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results”); see also id. at 420 (“A person of ordinary
skill is also a person of ordinary creativity, not an automaton”).
Appellant also contends that the Examiner improperly relied upon
hindsight analysis in establishing the prima facie case of obviousness. We
disagree.
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.

In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). Appellant adduces
no objective evidence of record that the Examiner relied upon knowledge
that could have been obtained only from Appellant’s Specification. We
consequently affirm the Examiner’s rejection of the claims.

B. Claims 6, 7, 16, and 17
Issue
Appellant argues that the Examiner erred because the combined cited
prior art does not teach the limitations of claims 6, 7, 16, and 17. App. Br.
15. Dependent claims 6 and 16 recite a solid drug unit in which the drug
comprises lidocaine, whereas dependent claims 7 and 17 recite a solid drug
unit in which the mini-tablet is between 85 weight percent and 95 weight
percent lidocaine. Id.

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Analysis
Appellant contends that Peppas does not provide any teaching
regarding lidocaine-containing minitablets, and the Examiner therefore relies
upon Rosa as teaching that lidocaine and benzocaine are “equally efficient in
reducing pain.” App. Br. 15. However, argues Appellant, Rosa teaches
topical anesthetics injected into a patient’s palate in solution form, and
provides no teaching regarding orally administered solid drug tablets, such
as those taught by Politi and Peppas. Id.
Furthermore, argues Appellant, benzocaine and lidocaine are physico-
chemically different molecules, and behave differently when granulated and
compressed. App. Br. 15. According to Appellant, the fact that topical
applications of lidocaine and benzocaine are “equally efficient in reducing
pain” does not render the drugs equivalents or substitutes for use in drug
tablets with any degree of predictability. Id. Therefore, Appellant asserts, a
person of ordinary skill in the art would not have been led to derive a tablet
of granulated lidocaine based upon the teachings of Peppas and Rosa. Id.
We are not persuaded by Appellant’s arguments. As an initial matter,
we disagree with Appellant’s description of the studies presented in Rosa.
Contrary to Appellant’s assertion that “Rosa relates to topical anesthetics
injected in a patient’s palate in solution form” (App. Br. 15), Rosa teaches:
The subjects ….were topically treated with one of the above
drugs in random order. A cotton swab was inserted into the paste
and rotated clockwise 3 times to standardize the amount of drug
applied. At each session, a 27-gauge needle was inserted into the
palate next to the greater palatine foramens twice, once before
(baseline) and the other after (test) drug application for 1 minute.
Immediately after each insertion, subjects indicated on a VAS
the pain intensity perceived. No anesthetic solution was injected,
nor was any other type of procedure carried out.
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Rosa 98 (emphases added). In other words, the use of the needle inserted
into the subjects’ palate was to present a painful stimulus against which the
efficacy of the topical6 anesthetic could be measured.
Furthermore, Rosa teaches that “[t]he results of this study showed that
lidocaine and benzocaine were equally efficient in reducing pain caused by
insertion of needles into the palate, and both were better than placebo.”
Rosa 98. Peppas and Rothbard both teach solid drug compositions
containing anesthetic agents: Peppas teaches that local anesthetics
(including benzocaine) can be used, and Rothbard teaches that pills
containing anesthetics can be inserted into the urethra. Peppas ¶ 92;
Rothbard ¶ 123. Rosa teaches that lidocaine and benzocaine are equally
effective as topical anesthetics. Rosa 98.
We agree with the Examiner’s finding that Rosa teaches that
benzocaine and lidocaine are therefore functionally equivalent. We find no
merit in Appellant’s argument that benzocaine and lidocaine “behave very
differently when granulated and compressed” (see App. Br. 15), because
Appellant adduces no objective evidence of record to support this
contention, and we accord such unsupported attorney argument little
probative weight. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997)

6 We also note that the medical definition of “topical” is “designed for or
involving application to or action on the surface of a part of the body.”
Topical, MERRIAM WEBSTER MEDICAL DICTIONARY, available at:
https://www.merriam-webster.com/dictionary/topical#medicalDictionary
(last visited April 6, 2020) (emphasis added). As such, topical does not
apply to agents that are injected into the body.
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(holding that attorney arguments and conclusory statements that are
unsupported by factual evidence are entitled to little probative value).
Appellant also repeats the arguments presented supra that the
combined cited prior art references do not teach or suggest a solid drug
composition containing 85–95% by weight of an active agent. We have
explained our reasoning as to why we are not persuaded by Appellant’s
argument, and we incorporate that reasoning here by reference.
We consequently affirm the Examiner’s rejection of the claims.

C. Claims 9 and 19
Issue
Dependent claim 9 is representative and recites: “The solid drug unit
of claim 1, wherein the mini-tablet is sterilized.” App. Br. 22. Appellant
argues that the Examiner erred because the cited prior art references neither
teach nor suggest this limitation. App. Br. 17.

Analysis
The Examiner finds that sterilization is common feature of regulated
pharmaceuticals. Final Act. 11. The Examiner reasons that such a feature
would also be more desirable if the tablet is intended for introduction in to
the urethra, where reducing the risk of infection would be a goal, as opposed
to if the tablet were simply intended for oral administration. Id.
Appellant points out that none of the cited references teach or suggest
that its dosage forms be sterilized. App. Br. 17. Furthermore, Appellant
argues, the Examiner has repeatedly failed to respond to Appellant’s
submitted evidence, namely ISPE, Oral Solid Dosage Forms, Course
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Description 1–3 (undated) (“ISPE”), which illustrates that solid dosage
forms are commonly produced in non-sterile environments. Id. Appellant
also points to J.E. Martinez, Microbial Bioburden on Oral Solid Dosage
Forms, PHARM. TECH. 58–70 (February 2002) (“Martinez”), which teaches
that sterilization is not a common feature of regulated oral pharmaceuticals,
and instead teaches that “this attitude [that food and oral drugs must be
sterile] is not in the best interest of the consumer. Sterilization of food and
drugs is expensive, and the extra cost, when it is not necessary, is paid by the
consumer and is a waste of money.” Id. (citing Martinez 66).
Appellant notes further that the Examiner finds that sterilization
“would also be more desirable if the tablet is intended for introduction in to
the urethra wherein reducing the risk of infection would be a goal as
opposed to if tablet were simply intended for oral administration.” App. Br.
18 (quoting Final Act. 11). However, Appellant argues, the Examiner
continues to fail to cite any support for this conclusory statement; Appellant
contends, rather, that this rejection is based on improper hindsight
reconstruction using Appellant’s Specification as a blueprint. Id.
Appellant also notes that the Examiner finds that “it is an undeniable
matter of common sense to the general population not to stick dirty
unsterilized needles or medical devices in[to] the body, it would not be any
different with injectable or insertable drug tablets.” App. Br. 19 (quoting
Final Act. 6). Appellant argues that this finding is not commensurate with
Appellant’s claims, as “unsterilized” is not synonymous with “dirty.” Id.
Appellant asserts that the evidence presented demonstrates that drug tablets
are commonly not sterilized, although nevertheless being recommended for
insertion and administration to the body. Id.
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We are not persuaded by Appellant’s argument. The Examiner has
taken notice that sterilization is a common, if not universal procedure for
medical devices that are to be inserted into the body, so as to prevent
infection. The Examiner has therefore concluded that it would have been
obvious to a person of ordinary skill in the art to sterilize a solid drug
composition that was intended to be inserted into the urethra, as claimed by
Appellant. We do not see the flaw in this logic.
Nor are we persuaded that Appellant’s rebuttal evidence is relevant to
this analysis. First, we are unable to discern any express teaching in ISPE
that either sterile or non-sterile procedures are used in the manufacture of
oral drug compositions. Second, both ISPE and Martinez are directed to
orally ingested medications, and not to solid drug compositions intended to
be inserted into the urethra. See ISPE 1–3; Martinez 66. Absent any
evidence to support the contention that solid drug compositions intended to
be inserted into the urethra are generally or routinely not sterilized, we are
not persuaded that Appellant’s arguments are sufficient to overcome the
Examiner’s prima facie conclusion that claims 9 and 19 are obvious over the
combined cited prior art and the knowledge of a person of ordinary skill in
the art. We therefore affirm the Examiner’s rejection of the claims.

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CONCLUSION
The rejection of claims 1–20 as unpatentable under 35 U.S.C. § 103 is
affirmed.
The rejection of claims 1–20 as unpatentable under the nonstatutory
doctrine of obviousness-type double patenting is affirmed.7
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED

Claims
Rejected
35 U.S.C. § Reference/Basis Affirmed Reversed
1–7, 9–17,
19, 20
103 Politi, Peppas, Pryce
Lewis, Pich, Rosa,
Rothbard
1–7, 9–17,
19, 20

8, 18 103 Politi, Peppas, Pryce
Lewis, Pich, Rosa,
Rothbard, Huynh-Ba
8, 18
1–20 Obviousness-
type double
patenting
’974 application 1–20
Overall
Outcome
1–20

7 See fn.2 supra.