Ex Parte Chickmath et al

Patent Trials and Appeals Board

Mar 19, 2019

14500498 - (D) (P.T.A.B. Mar. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
14/500,498
123671 7590
TNW-Lipocine
P.O. Box 1219
FILING DATE
09/29/2014
03/21/2019
Sandy, UT 84091-1219
FIRST NAMED INVENTOR
Basawaraj Chickmath
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.
01235-36022.DIVl 5851
EXAMINER
CHANG, KYUNG SOOK
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
03/21/2019 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):
kg@lipocine.com
patentdocket@tnw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BASAWARAJ CHICKMATH, CHANDRASHEKAR GILIYAR,
NACHIAPPAN CHIDAMBARAM, MARESH V. PATEL, and
SRINIVASAN VENKA TESHW ARAN
Appeal2018-002004
Application 14/500,498 1
Technology Center 1600
Before JEFFREY N. FREDMAN, ELIZABETH A. LA VIER, and
RYAN H. FLAX, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejections of claims 41, 42, 44--49, and 51-69. We have
jurisdiction under 35 U.S.C. § 6(b ). For the reasons set forth below, we
AFFIRM-IN-PART.
1 Appellants identify the real party in interest as Lipocine, Inc. Br. 3.
Appeal2018-002004
Application 14/500,498
BACKGROUND
The Specification describes pharmaceutical compositions of
testosterone undecanoate, and related treatment methods. Spec. 3: 5-6.
Claim 41 is illustrative:
A method for replacement therapy in males having a condition
or a symptom associated with a deficiency or absence of
endogenous testosterone, said method comprising
orally administering, with food having 10 to 50 grams of fat, to
males having a condition associated with a deficiency or
absence of endogenous testosterone twice daily a tablet
comprising 100 mg to 400 mg testosterone undecanoate and a
pharmaceutically acceptable carrier including at least one of
polyvinyl alcohol, polyvinyl pyrrolidones, polyethylene
glycols having molecular weight from about 100 to about
20,000; propylene glycol; starches; sodium starch
glycolate; croscarmellose; sucrose; lactose;
cyclodextrins; carboxymethyl cellulose; microcrystalline
cellulose, hydroxyl propyl methyl cellulose; ethyl
cellulose; carbomers; gelatin; poloxamers; sodium
dodecyl sulfate; sodium docusate; polyoxyethylene
sorbitan esters; glycerin; paraffin oil; silicone oils;
magnesium aluminosilicates; silicon dioxide; ethyl
alcohol; benzyl alcohol; benzyl benzoate; ascorbic acid;
or mixtures thereof
said method providing a serum testosterone mean Cavg in the
range of 400 ng/dL to 600 ng/dL wherein said tablet releases at
least 45% of the testosterone undecanoate at 120 minutes and
less than 85% of the testosterone undecanoate at 30 minutes
when tested, using a USP Type II apparatus, in 1000 mL of 8
wt% Triton X-100 at 37 °C and 100 rpm.
Br. 29 (Claims Appendix) (some formatting and emphasis added).
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Appeal2018-002004
Application 14/500,498
REJECTIONS MAINTAINED ON APPEAL
1. Claims 67----69 stand rejected under 35 U.S.C. § 112, first
paragraph (pre-AIA) as lacking written description support. Ans. 2.
2. Claims 41, 42, 44--49, and 51----69 stand rejected under
35 U.S.C. § I03(a) (pre-AIA) as unpatentable over Dhingra, 2
Schnabel, 3 Fikstad,4 and Heubler. 5 Ans. 3.
DISCUSSION
A. Rejection 1 (§ 112)
The test for determining whether a specification is sufficient to
support a particular claim "is whether the disclosure of the application relied
upon 'reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter."' Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re
Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)). "But merely drawing a
fence around the outer limits of a purported genus is not an adequate
substitute for describing a variety of materials constituting the genus and
showing that one has invented a genus and not just a species." Ari ad
2 Dhingra, US 2011/0160168 Al, published June 30, 2011.
3 Peter G. Schnabel et al., The Effect of Food Composition on Serum
Testosterone Levels after Oral Administration of Andria!® Testocaps®, 66
CLIN. ENDOCRINOLOGY 579-585 (2007).
4 Fikstad et al., US 2006/0003002 Al, published Jan. 5, 2006.
5 Huebler et al., US 6,977,083 Bl, issued Dec. 20, 2005.
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Appeal2018-002004
Application 14/500,498
Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en
bane).
The Examiner rejects dependent claims 67----69 under§ 112, first
paragraph, on the basis that the negative limitation recited in each of these
claims, "that the composition does not contain a phytosterol or phytosterol
ester" (Br. 33 (Claims Appendix)), is not supported in the originally filed
application. See Final Action 5----6. Appellants argue that "compounds such
as phytosterols, cholesterol, etc. are considered lipid substances or lipophilic
surfactants" (Br. 13), and the Specification expressly provides support for
compositions lacking such substances, as follows:
The oral dosage forms may also be free of oils. As used herein,
the term "oils" refers to pharmaceutically acceptable glycerides
that have a triglyceride content of at least 40 wt%. Similarly,
another embodiment of the invention provides for the oral
dosage form to be free of triglycerides. In one embodiment, the
pharmaceutically acceptable carrier in the dosage form is not a
lipid substance.
Spec. 16: 17-21.
Negative claim limitations find adequate written description support
where "the specification describes a reason to exclude the relevant
limitation," Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d 1344, 1351
(Fed. Cir. 2012), which can be accomplished "by properly describing
alternative features" of the invention, Inphi Corp. v. Netlist, Inc., 805 F.3d
1350, 1356 (Fed. Cir. 2015). Here, however, the Specification is silent
regarding whether phytosterols or phytosterol esters may be excluded, and
is, by extension, likewise devoid of any discussion of reasons or alternative
features pertaining to the exclusion of these particular types of substances.
The optional exclusions of "oils," "triglycerides," and "lipid substance[ s ]"
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Appeal2018-002004
Application 14/500,498
provided in the Specification (Spec. 16: 17-21) are too broad to show
possession of the much more particularized subject matter of claims 67----69.
In other words, the negative genus recited in the Specification does not
provide adequate support for the negative species recited in claims 67-69.
Accordingly, we affirm Rejection 1.
B. Rejection 2 (§ 103)
Although the Examiner recognizes (see Final Action 12) that Dhingra
does not expressly teach the release rate limitations of claim 41 ( emphasized
above), the Examiner finds these to be inherent properties of the
compositions of Dhingra:
[T]herefore, considering Dhingra uses the same hydrophilic
carrier PVP, PEG, glycol, etc. for the same therapeutic agent
TU[6] in overlapping amount as in Applicant's invention, the
method for treating hypogonadism using the composition of
Dhingra would implicitly provide the claimed release rate of
instant claims 41, 48 and 56, absence [sic] evidence to the
contrary.
Final Action 13; see also Ans. 10.
Appellants argue that most of Dhingra's formulations do not achieve
the claimed release rates (see Br. 20), and that some compositions of
testosterone undecanoate described in the Specification have release profiles
falling outside the scope of claim 41 (see id. at 23). In particular, Appellants
point to Specification Examples 6 and 23, which show release profiles of
less than 35% at 120 minutes. Id. Accordingly, Appellants conclude that
6 The abbreviation "TU" finds occasional use throughout the record to refer
to testosterone undecanoate.
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Appeal2018-002004
Application 14/500,498
"this property does not necessarily flow from the prior art as required to
support an inherency based rejection." Id.
The Examiner counters by pointing to certain embodiments of
Dhingra that do achieve the claimed release rates. See Ans. 11-14.7 As to
Examples 6 and 23 of the Specification, the Examiner asserts that they are
"not commensurate with the scope of [the] base claims." Id. at 15. The
Examiner reasons that the particle size used in Example 6 is large (more than
50 microns) and claim 41 "does not require such significant particle size of
TU." Id. As to Example 23, the Examiner states that it "uses 91 % TU and
9% solvent with outside scope release profile 12% at 30 minutes and 32% at
120 minutes (see instant Table VII). It is noted that depending on amounts
of TU and carrier, the release profiles vary." Id. ( emphasis added).
The emphasized sentence drives at the critical point: depending on
features of the tablet that are not specified in claim 41 (e.g., particle size of
testosterone undecanoate; relative amount of carrier; whether additional
components are added and the nature thereof), performing the method of
administration as recited in claim 41 may, or may not, result in the claimed
release rates. The large particle size of Example 6 or the component
amounts of Example 23 do not place either outside the parameters for the
tablet used in the method of claim 41. Accordingly, the release rates recited
7 To the extent the Examiner is providing an obviousness rationale wholly
independent from inherency (see Ans. 11-13 ( discussing Capsules 2 and 4
reported in Dhingra Fig. 2)), this appears to be new to the Answer. In any
event, these refer to capsule formulations, not tablets as recited in claim 41.
For at least this reason, the Examiner's discussion on pages 11-13 of the
Answer is not itself sufficient to constitute a stand-alone alternative basis for
concluding that claim 41 is obvious (nor is it framed as such).
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Application 14/500,498
in claim 41 are not inherent in, or implied by, the disclosure in the prior art
of the same carrier( s) and the claimed amount of testosterone undecanoate.
See PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195 (Fed. Cir.
2014) ("[T]he concept of inherency must be limited when applied to
obviousness, and is present only when the limitation at issue is the natural
result of the combination of prior art elements." ( quotation omitted)).
For these reasons, we reverse the Examiner's rejection of claim 41
under § 103. The other independent claims, claims 48 and 56, recite similar
limitations. Thus, we reverse the § 103 rejection as to claims 42, 44--49, and
51-69 as well.
CONCLUSION
We affirm Rejection 1. We reverse Rejection 2.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRM-IN-PART
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