Giliyar et al.v.DUDLEY et al. V. Giliyar et al.

Patent Trials and Appeals Board

Nov 16, 2020

15723976 - (J) (P.T.A.B. Nov. 16, 2020)

BoxInterferences@uspto.gov Filed:16 November 2020
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

LIPOCINE, INC.
(Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram,
Mahesh V. Patel and Srinivasan Venkateshwaran)

Junior Party
(Patent Application 12/350,930 and Patent 8,778,922),

v.

CLARUS THERAPEUTICS, INC.
(Inventors: Robert E. Dudley and Panayiotis P. Constantinides)

Senior Party
(Patent Application 15/723,976).

Patent Interference No. 106,120 (DK)
(Technology Center 1600)

Judgment
37 C.F.R. § 41.127(a)

Before SALLY GARDNER LANE, JAMES T. MOORE, and
DEBORAH KATZ, Administrative Patent Judges.

KATZ, Administrative Patent Judge.

Interference 106,120

-2-
The Decision on Motions in this interference granted Junior Party Lipocine, 1
Inc. (“Lipocine”) Motion 1 arguing that the involved claims of Senior Party Clarus 2
Therapeutics, Inc. (“Clarus”) are barred under 35 U.S.C. § 135(b)(1).1 (See Paper 3
79.) Accordingly, we enter judgment against Clarus. 4
It is ORDERED that judgment on priority is entered against Clarus as to 5
Count 1, the sole count of the interference (see Redeclaration, Paper 18, 3); 6
It is FURTHER ORDERED that claims 28, 32, and 34 of Clarus application 7
15/723,976, which correspond to Count 1 (see id. at 4), are FINALLY REFUSED 8
(see 35 U.S.C. § 135(a); 9
It is FURTHER ORDERED that the parties are directed to 35 USC § 135(c) 10
and 37 C.F.R. § 41.205 regarding the filing of settlement agreements; 11
It is FURTHER ORDERED that a party seeking judicial review2 timely 12
serve notice on the Director of the United States Patent and Trademark Office (see 13
37 C.F.R. § 41.8(b)); and 14
It is FURTHER ORDERED that a copy of this judgment be entered into the 15
administrative records of the involved Lipocine application and patent and the 16
Clarus application. 17

1 Any reference to a statute in this Judgment is to the statute that was in effect on
March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat.
284, 293 (2011).
2 Attention is directed to Biogen Idec MA, Inc., v. Japanese Foundation for Cancer
Research, 785 F.3d 648, 18 654–57 (Fed. Cir. 2015) (determining that pre-AIA §
146 review was eliminated for interference proceedings declared after September
15, 2012)
Interference 106,120

-3-
cc (via e-mail):

Attorney for Junior Party Lipocine
Marc M. Wefers
Chris C. Bowley
Fish & Richardson P.C.
wefers@fr.com
bowley@fr.com

Attorney for Senior Party Clarus

Christopher T. Griffith
Green, Griffith & Borg-Breen LLP
clarus@greengriffith.com

Dennis A. Bennett
Global Patent Group, LLC
dennisbennett@globalpatentgroup.com

Joseph M. Skerpon
Banner & Witcoff, Ltd.
jskerpon@bannerwitcoff.com

BoxInterferences@uspto.gov Filed: 16 November 2020
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

LIPOCINE, INC.
(Inventors: Chandrashekar Giliyar, Nachiappan Chidambaram,
Mahesh V. Patel and Srinivasan Venkateshwaran)

Junior Party
(Patent Application 12/350,930 and Patent 8,778,922),

v.

CLARUS THERAPEUTICS, INC.
(Inventors: Robert E. Dudley and Panayiotis P. Constantinides)

Senior Party
(Patent Application 15/723,976).

Patent Interference No. 106,120 (DK)
(Technology Center 1600)

Decision on Motions
37 C.F.R. § 41.125(a)

Before SALLY GARDNER LANE, JAMES T. MOORE, and
DEBORAH KATZ, Administrative Patent Judges.

KATZ, Administrative Patent Judge.
Interference 106,120

-2-
Introduction 1
Junior Party Lipocine, Inc. (“Lipocine”) is involved in this interference 2
based on its patent application 12/350,930 and patent 8,778,922 (“the ’922 3
patent”). Senior Party Clarus Therapeutics, Inc. (“Clarus”) is involved based on its 4
patent application 15/723,976 (“the ’976 application“).1 (See Declaration, Paper 1; 5
see Redeclaration, Paper 18.) Both parties’ claims are drawn to oral 6
pharmaceutical compositions including testosterone undecanoate, a lipophilic 7
surfactant or carrier, polyoxyl 40 hydrogenated castor oil and a solidifying agent. 8
(See Lipocine Clean Copy of Claims, Paper 6; see Clarus Clean Copy of Claims, 9
Paper 11.) 10
Lipocine filed three substantive motions in this proceeding: Motion 1 for 11
judgment under 35 U.S.C. § 135(b),2 Motion 2 for judgment based on lack of 12
written description, and Motion 3 to deny Clarus benefit of accorded earlier filing 13
dates. (See Papers 21, 22, 23.) Clarus filed a notice indicating that it would not 14

1 Prior Interference 106,045 involved the same parties, but Lipocine was involved
based on application 14/713,692 and Clarus was involved based on patent
8,282,428. (See Interference 106,045, Redeclaration, Paper 350.) The count in
that proceeding was similar to the current count, being drawn to an oral
pharmaceutical composition comprising testosterone undecanoate, a lipophilic
surfactant chosen from mono and/or di-glycerides of fatty acids, polyoxyl 40
hydrogenated castor oil, and a specified polyethylene glycol. (Interference
106,045, Declaration, Paper 1, 4–5.) Judgment was entered against Clarus in
Interference 106,045, following a decision granting Lipocine’s motion for priority
and appeal to the Federal Circuit. (Interference 106,045, Paper 390, 392.)
2 Any reference to a statute in this Judgment is to the statute that was in effect on
March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat.
284, 293 (2011).
Interference 106,120

-3-
file substantive oppositions to any of these motions, but that it does not concede 1
that Lipocine has carried its burden in any of them. (See Notice by Senior Party 2
Regarding Lipocine, Inc.’s Motions 1-3, Paper 75.) Clarus did not file any 3
substantive motions. 4
We “may take up motions for decisions in any order, may grant, deny, or 5
dismiss any motion, and may take such other action appropriate to secure the just, 6
speedy, and inexpensive determination of the proceeding.” 37 C.F.R. § 41.125(a). 7
We consider Lipocine’s Motion 1 first and grant that motion. Because it presents a 8
threshold issue, our decision is dispositive of the proceeding and we need not 9
consider Lipocine’s other motions. See 37 C.F.R. § 41.201. 10
11
Lipocine Motion 1 12
Under 35 U.S.C. § 135(b)(1), 13
[a] claim which is the same as, or for the same or substantially the same 14
subject matter as, a claim of an issued patent may not be made in any 15
application unless such a claim is made prior to one year from the date on 16
which the patent was granted. 17
18
This section is a statute of limitations on interferences, wherein a party must 19
present claims to the same or substantially the same subject matter as patented 20
claims within a year of the issue date of the patent. In re Berger, 279 F.3d 975, 21
982 (Fed. Cir. 2002). To avoid the statute of limitations imposed by section 22
135(b), the later claim may be entitled to an earlier effective date if the later claim 23
does not differ from earlier claims in any material limitation. See id. 24
Interference 106,120

-4-
Lipocine argues that judgment should be entered against Clarus because its 1
involved claims are barred under 35 U.S.C. § 135(b)(1). (See Lipocine Motion 1, 2
Paper 21, 1:2–5.) Specifically, Lipocine argues that the involved Clarus ’976 3
application was filed on 3 October 2017, more than three years after issue of the 4
involved Lipocine’922 patent on 15 July 2014. (See Lipocine Motion 1, Paper 21, 5
3:12–4:17.) Lipocine argues further that Clarus has not challenged the declaration 6
of this interference, which created the presumption that all of the claims of the 7
Clarus ’976 application anticipate or render obvious all of the claims of the claims 8
of the Lipocine ’922 patent and vice versa. (See Lipocine Motion 1, Paper 21, 4:6–9
9, citing Order Authorizing Motions and Setting Times, Paper 17, 2 (“In addition, 10
the issue of whether to add the ’922 patent to the interference was discussed. 11
Neither party argued that it should not be added.”); see 37 C.F.R. § 41.203(a).) 12
Thus, because of undisputed interference between the claims, Lipocine argues that 13
Clarus’s involved claims are drawn to the same or substantially the same subject 14
matter as Lipocine’s involved claims and are not patentable under 35 U.S.C. 15
§ 135(b)(1), having been filed more than one year after issue of Lipocine claims. 16
The record supports Lipocine’s argument and it is sufficient to persuade us 17
that the involved Clarus ’976 application claims are barred under 35 U.S.C. 18
§ 135(b). Because Clarus fails to put forth any argument or evidence that it avoids 19
this statute of limitations by relying on the earlier filing date of claims that do not 20
differ from its involved claims in any material limitation, we grant Lipocine 21
Motion 1. See In re Berger, 279 F.3d 975, 981–82 (Fed. Cir. 2002) (“To establish 22
entitlement to the earlier effective date of existing claims for purposes of the one-23
year bar of 35 U.S.C. § 135(b), a party must show that the later filed claim does not 24
Interference 106,120

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differ from an earlier claim in any ‘material limitation.’ Corbett v. Chisholm, 568 1
F.2d 759, 765–66, 196 USPQ 337, 343 (CCPA 1977).”). 2
We briefly review Lipocine’s further arguments and evidence, which 3
support this determination. Lipocine relies on the testimony of Edmund J. Elder, 4
Jr., PhD. in support of its further arguments. (See Declaration of Dr. Edmund J. 5
Elder, Jr., Ph.D. (“Elder Decl.”), Ex. 2001.) Dr. Elder’s testimony of his 6
background and experience persuades us that he is qualified to provide expert 7
opinion testimony about the subject matter of the interference. (See Elder’s Decl. 8
Ex. 2001, ¶¶ 9–20.) 9
Lipocine argues that the parties claim at least substantially the same subject 10
matter because both parties’ claims recite an oral pharmaceutical comprising 11
testosterone undecanoate (“TU”), glyceryl monolinoleate (“GML”), and polyoxyl 12
40 hydrogenated castor oil (“P40HCO”). (Lipocine Motion 1, Paper 21, 5:41–6:1, 13
citing Elder Decl., Ex. 2001, ¶¶ 50–56, 120–122.) Lipocine argues that Clarus 14
claim 28 recites weight percent ranges for TU, GML, and P40HCO that are 15
encompassed by and “readily envisioned” within the ranges recited in Lipocine 16
patent claims 3 and 8. (See Lipocine Motion 1, Paper 21, 6:1–4, citing Elders 17
Decl., Ex. 2001, ¶¶ 122–123.) Claims 3 and 8 of the ’922 Lipocine patent recites 18
10–20 w/w% TU, 50–70w/w% GML, and 10–20 w/w% P40HCO, which 19
encompass the corresponding concentrations recited in Claus claim 28 of 15 wt% 20
TU, about 55–65 wt.% GML, and about 15% % wt. P40HCO. (See ’299 patent, 21
Ex. 2002, 63:4–12; see Clarus Clean Copy of Claims, Paper 11.) We agree that the 22
later filed Clarus claims recite a composition with the same or substantially the 23
Interference 106,120

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same composition of TU, GML, and P40HCO as the earlier issued Lipocine claims 1
in the absence of evidence to the contrary. 2
Lipocine argues further that both parties’ claims are drawn to the same or 3
substantially the same subject matter because both recite “semi-solid” 4
formulations. (See Lipocine Motion 1, Paper 21, 6:5–6.) Lipocine argues that both 5
Lipocine claim 8 and Clarus claim 28 recite that twice daily administration of the 6
formulation achieves a testosterone concentration in blood generally corresponding 7
to the range for a healthy male. (See Lipocine Motion 1, Paper 21, 6:14–18.) 8
Although, Lipocine claim 8 recites “a plasma testosterone concentration in the 9
range of about 250 ng/dL to about 1200 ng/dL” and Clarus claim 28 recites “a 10
serum concentration of testosterone ranging from about 300 to about 1100 ng/dL.” 11
Dr. Elder’s testimony supports the argument that these slightly different ranges 12
both represent a range for a healthy male. (See Lipocine Motion 1, Paper 21, 6:14–13
18; see Elder Decl., Ex. 2001, ¶¶ 55–56, 126.) 14
Furthermore, although Clarus claim 28 requires the semi-solid “encased in a 15
capsule,” Lipocine argues that it was well known to encase an oral pharmaceutical 16
formulation in a capsule, relying on Dr. Elder’s testimony. (See Lipocine Motion 17
1, Paper 21, 6:10–14, citing Elder Decl., Ex. 2001, ¶ 124.) 18
Lipocine’s arguments reinforce the determination made when the 19
interference was declared that Clarus’s involved claims recite the same or 20
substantially the same subject matter as the Lipocine ’299 patent. 21
Under 35 U.S.C. § 135(b), “a copied claim may be entitled to the earlier 22
effective date of prior claims in an application only if the copied claim does not 23
differ from the prior claims in any material limitation.” Berger, 279 F.3d at 982. 24
Interference 106,120

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The determination of whether a limitation is material involves a comparison 1
between pre- and post-critical date claims, wherein a limitation is presumed to be 2
material when it is added to a pre-critical date claim to overcome an Examiner’s 3
rejection. See Regents of the Univ. of Cal. v. University of Iowa Res. Found., 455 4
F.3d 1371, 1375 (Fed. Cir. 2006); see Adair v. Carter, 668 F.3d 1334, 1339 (Fed. 5
Cir. 2012) (citations omitted). The critical date for Clarus, that is, the date by 6
which Clarus must have presented claims that do not differ in any material 7
limitation from its current claims, is 15 July 2015, one year from issue of the 8
Lipocine ’922 patent. 9
Lipocine argues that prosecution of the involved ’976 application 10
demonstrates that Clarus cannot rely on a pre-critical date claim in light of 11
amendments Clarus made to avoid rejections by the Examiner over prior art. (See 12
Lipocine Motion 1, Paper 21, 7:8–8:5.) Specifically, Lipocine argues that the 13
limitation to “administration of the formulation twice daily provides a serum 14
concentration of testosterone ranging from about 300 to about 1100 ng/dL,” the 15
limitation to “about 15 % wt.” P40HCO, and the limitation to require that the 16
lipophilic surfactant “consists of” GML were made in two amendments dated 2 17
January 2019 and 11 June 2019 in response to rejections by the Examiner. (See 18
id., citing Response to Non-Final Rejection in ’976 appl. filed 2 January 2019, Ex. 19
2039, 4–6 and Response to Final Rejection in ’976 appl. filed 11 June 2019, Ex. 20
2006, 2.) Lipocine argues that because these limitations were added to achieve 21
patentability, they are material limitations. We agree, in the absence of persuasive 22
evidence or argument to the contrary. 23
Interference 106,120

-8-
Lipocine argues further that Clarus did not present claims in any benefit 1
application that included all of these material limitations by the critical date. (See 2
Lipocine Motion 1, Paper 21, 9:16–10:25.) Lipocine argues that no claim in any 3
Clarus benefit application was drawn to a pharmaceutical formulation “consisting 4
of” GML, reciting the ranges of TU, GML, or P40HCO in involved Clarus claim 5
28, or reciting the limitation to “administration of the formulation twice daily 6
provides a serum concentration of testosterone ranging from about 300 to about 7
1100 ng/dL” also recited in Clarus claim 28. (Lipocine Motion 1, Paper 21, 12:6–8
11.) 9
In the absence of an opposition from Clarus pointing to a pre-critical date 10
claim that recites these limitations, we agree with Lipocine. We agree with 11
Lipocine that Clarus cannot rely on an earlier filing date for its involved claims and 12
that because its involved claims recite the same or substantially the same subject 13
matter as the claims of the involved Lipocine ’922 patent, but were filed more than 14
a year of the issue of that patent, the Clarus claims are unpatentable under 35 15
U.S.C. § 135(b). 16
Lipocine Motion 1 for patentability under 35 U.S.C. § 135(b) is a threshold 17
motion that deprives Clarus of standing in this proceeding. See 37 C.F.R. § 41.201 18
(“Threshold issue means an issue that, if resolved in favor of the movant, would 19
deprive the opponent of standing in the interference. Threshold issues may include 20
. . . (i) Repose under 35 U.S.C. 135(b) in view of the movant's patent or published 21
application . . . .”). Thus, because we grant Lipocine Motion 1, Lipocine Motions 22
2 and 3 are moot and we need not review them. We enter judgment against Clarus 23
in a separate paper. 24
Interference 106,120

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cc (via e-mail):

Attorney for Junior Party Lipocine
Marc M. Wefers
Chris C. Bowley
Fish & Richardson P.C.
wefers@fr.com
bowley@fr.com

Attorney for Senior Party Clarus

Christopher T. Griffith
Green, Griffith & Borg-Breen LLP
clarus@greengriffith.com

Dennis A. Bennett
Global Patent Group, LLC
dennisbennett@globalpatentgroup.com

Joseph M. Skerpon
Banner & Witcoff, Ltd.
jskerpon@bannerwitcoff.com