Ex Parte Salatinjants et al

Patent Trial and Appeal Board

Jun 23, 2014

13709381 (P.T.A.B. Jun. 23, 2014)

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.
13/709,381 12/10/2012 Aida Salatinjants 185-102 C 4802
41576 7590 06/24/2014
JOSEPH E. MUETH
JOSEPH E. MUETH LAW CORPORATION
100 E. CORSON ST., STE. 300
PASADENA, CA 91103-3842
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
06/24/2014 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 AIDA SALATINJANTS and ROBERT SALANTINJANTS
____________

Appeal 2014-006429
Application 13/709,381
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of administering rifampicin in conjunction with a prolongation composition.
The Examiner has rejected the claims on the grounds of non-statutory
obviousness-type double patenting and obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

1 Appellants state that the Real Party in Interest is Aida Salatinjants, M.D.
and Robert Salatinjants (App. Br. 3).
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STATEMENT OF THE CASE
The Specification is directed to disclosing a composition that
“increases the half-life, efficacy and pharmacological activity of various
medications . . . which thereby provides more uniform plasma levels and
increases the effect of active drugs. As a result, the dosing-requirement of
the active drug is greatly reduced.” (Spec. 2.)
Claim 1 is on appeal, and can be found in the Claims Appendix of the
Appeal Brief. Claim 1 reads as follows:
1. In the method of administering rifampicin to a human subject,
the improvement wherein a prolongation composition is also
administered, said prolongation composition comprising:
Pectin 0.94g
Potassium bitartrate 0.48g
Tannic acid 0.8g
L-Tyrosine 0.21g
Riboflavin 2 ml 10% solution of 15%
Ethyl Alcohol
Hexanoic Acid (Caproic acid) 0.06 ml
Ethyl Alcohol 15% Ethyl Alcohol to make
100 ml
The Examiner has rejected the claim as follows:
I. claim 1 under 35 U.S.C. § 103(a) as unpatentable over
Salatinjants ’9522 in view of Singh,3 Peloquin,4 Lerner,5 Dunn6 and Zanchi7
(Non-Final Act. 4); and

2 Salatinjants, US 4,708,952, issued Nov. 24, 1987.
3 Singh et al., Targeted Delivery of Rifampicin by Niosomal Drug Delivery
System, 3 J. PHAM. RES. 1152 (2010).
4 Peloquin et al., Pharmacokinetics of Rifampin Under Fasting Conditions,
With Food, and With Antacids, 115 CHEST 12 (1999).
5 Lerner et al., WO 99/04764, published Feb. 4, 1999.
6 Dunn, US 5,888,533, issued Mar, 30, 1999.
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II. claim 1 on the grounds of non-statutory obviousness-type
double patenting over claims 1 and 2 of Salatinjants ’173,8 in view of
Salatinjants ’952, Singh, Peloquin, Lerner, Dunn and Zanchi (Non-Final
Act. 18).

I. The Issue: Obviousness over Salatinjants ’952
The Examiner’s position is that Salatinjants ’952 “teaches a
composition adapted to prolong the residence time . . . [of] drugs in the
circulating plasma of mammals” (Non-Final Act. 4). “Singh teaches [that]
Rifampicin [RIF] is an effective drug for the treatment of tuberculosis.” (Id.
at 6.) In addition, Singh teaches that “rifampicin is an antimicrobial drug,
and the need for controlled release (prolongation) formulations of
rifampicin,” and that “sustained release formulations [can] overcome [the]
shortcoming[s] of rifampcin, [including] toxicity, decreased bioavailability
and noncompliance leading to drug resistance.” (Id. at 7.) The Examiner
finds that “Peloquin established rifampicin has very similar Tmax and half-
life characteristics as the Salatinjants drugs, including quinine.” (Ans. 17.)
Thus, according to the Examiner, “[b]oth Singh and Peloquin teach
rifampicin, and Singh establishes the need for sustained release of
rifampicin, to overcome the observed shortcomings of this drug, when used
in therapy of tuberculosis.” (Ans. 18.)
The Examiner finds that Lerner disclosed “polymer includes cellulosic
polymers . . . [the] preferred materials include[s] pectin . . . the composition
is made by dissolving the polymer in a solvent, adding tannic acid, then

7 Zanchi et al., Colloidal Dispersions of Tannins in Water-Ethanol Solutions,
23 LANGMUIR 9949 (2007).
8 Salatinjants, US 4,716,173, issued Dec. 29, 1987.
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allowing a precipitate to form.” (Non-Final Act. 9.) Lerner also disclosed
liquid formulations of ethanol and tannic acid ranging in concentration from
“3% ethanol with 47.5% water and 20% tannic acid . . . [additionally]
higher amounts of ethanol, such as about 50% ethanol/water . . . and
amounts over 50% ethanol in water are used with 10% tannic acid” (id.
at 10). The Examiner concludes that one of ordinary skill in the art at the
time the invention was made would have been motivated to
modify Drug No.2 solution taught by Salantinjants, by substituting
rifampicin for quinine (or alternately to substitute the Salantinjants
prolongation components for the Niosomal Drug Delivery System
taught by Singh), and to use 10 Times the amount of tannic acid from
that of the Salantinjants prolongation composition, i.e., 0.8g/100 ml,
which would be achieved by dissolving the components in 15%
ethanol. It would have further been obvious to optimize the solution
amount to 100 ml volume . . . . The use of the precise amounts of
0.8g/100 ml and 15% ethanol would have been the result of routine
optimization within the general parameters discussed in these prior art
references.
(id. at 16-17.)
Does the preponderance of evidence of record support the Examiner’s
position that the combination of references renders the claims obvious?

Findings of Fact
FF1. Singh disclosed:
Rifampicin is an effective drug for the treatment of tuberculosis.
There is evidence that rifampicin is having the antimicrobial activity
which has been attributed to the macrocyclic ring of the rifamycin
molecule . . . Short term chemotherapy [with rifampicin] involves
many disadvantages like toxicity, decreased bioavailability at the
target site and most important non compliance by the patient leading
to drug resistance. The short coming of chemotherapy can be
circumvented by developing a drug delivery system that would
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release the drug in a sustained manner.
(Singh, 1152 (emphasis added); see also Non-Final Act. 6, 7, 16; see
also Ans. 2, 4, 6, 16, 17.)
FF2. Salantinjants ’952 disclosed compositions to prolong the
residence time of drugs, specifically sulfa and cinchona alkaloid drugs
(Salantinjants ’952, col. 1, ll. 57-59; Non-Final Act. 5).
FF3. Salantinjants ’952 disclosed prolongation compositions:
The composition of Drug No. 1 was:
Hexanoic Acid: 0.06 grams
Tannic Acid: 0.08 grams
Pectin: 0.94 grams
Riboflavin 10%: 2.00 grams
Water to make 67 ml.

The composition of Drug No. 2 was:
Hexanoic Acid: 0.06 grams
Tannic Acid: 0.08 grams
Pectin: 0.94 grams
Riboflavin 10%: 2.00 grams
Potassium Hydrogen Tartrate: 0.48 grams
L-Tyrosine: 0.21 grams
Water to make 316 m1.
(Salantinjants ’952, col. 2, ll. 35-48; Non-Final Act. 6.)
FF4. The Examiner finds that “Salantinjants mentions antibacterial
drugs generically, but does not teach the recited drug rifampicin.” (Non-
Final. Act. 6.)
FF5. Lerner disclosed liquid compositions that comprise a polymer
and tannic acid or tannin. “The polymer may or may not form a precipitate
when mixed with the tannic acid or tannin.” (Lerner 23, ll. 3-4; see also
Ans. 10)
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FF6. The Examiner finds “that pectin is known as a cellulosic
polymer with gelation properties, i.e., within the general class of polymers
discussed by Lerner, and is specifically mentioned as a suitable polymer
material.” (Non-Final Act. 10.)
FF7. The Examiner finds that Lerner disclosed:
preferred solvents for polymer and tannic acid include water, ethanol
and mixtures of water and ethanol (p. 23, lines 22-23, 25-26; p. 24,
lines 2-3,6-7); in a preferred embodiment ethanol and water is used (p.
25, lines 12-14); amounts of ethanol include 3% ethanol with 47.5%
water and 20% tannic acid (about 6% ethanol as the solvent; p. 46,
lines 16-23; see also Table 17, p. 48); higher amounts of ethanol, such
as about 50% ethanol/water (p. 38, Table 6) and amounts over 50%
ethanol in water are used with 10% tannic acid (p. 35, Table 1; p. 38,
Table 5; p. 41, Tables 9-10)
(Non-Final Act. 10.)

Principle of Law
“Obviousness does not require absolute predictability of success.” In
re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Furthermore, the Supreme
Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), that
solving a problem by selecting from a limited number of known options is
obvious:
When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a
person of ordinary skill has good reason to pursue the known options
within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill
and common sense. In that instance the fact that a combination was
obvious to try might show that it was obvious under § 103.
Id. at 421.

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Analysis
Upon consideration of the evidence on this record, and each of
Appellants contentions, we find that the preponderance of evidence of record
supports the Examiner’s finding that the subject matter of Appellants claims
is unpatentable. We agree with the Examiner’s fact finding and responses to
Appellant’s arguments as set forth in the Non-Final Action and Answer.
According to the Examiner, “Singh establishes [that] rifampicin is an
antimicrobial drug, and the need for controlled release (prolongation)
formulations of rifampicin,” and that “sustained release formulations
overcome [the] shortcoming[s] of rifampcin, [including] toxicity, decreased
bioavailability and noncompliance leading to drug resistance.” (Non-Final
Act. 7, see also FF1.) The Examiner reasons that the “[a]pplication of
prolongation (extended release) solutions would have been expected to
benefit therapy using both drugs (rifampicin and quinine) in a similar
manner, i.e., to reduce the frequency of dosing, improving patient
compliance, reducing the level of drug at the peak, and associated side
effects.” (Ans. 4.) The Examiner concludes that, in view of the teachings of
Singh, “[i]n combination with Salantinjants, the skilled artisan would have
considered the prolongation formulation of Salantinjants as an alternate
controlled release composition to achieve the desired rifampicin controlled
release.” (Non-Final Act. 8.) The Examiner relies on Singh and Peloquin to
establish that rifampicin is a known drug for the treatment of tuberculosis
and that there is a need for formulating the compound into a sustained
release composition. (Ans. 18; see also FF1.)
Appellants contend that Peloquin concludes “that rifampicin should be
given on an empty stomach,” and that “Peloquin . . . if anything, steers one
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skilled in the art away from augmentation of RIF with a prolongation
solution.” (App. Br. 12.) Appellants direct our attention to other studies
related to the effect of food cited by Peloquin, namely Siegler,9 Zent,10
Polasa,11 and Hagelund12 (id). Based on these references, Appellants take
the position that “there is no coherent evidence to support this tacit
assumption of the part of the Examiner that the introduction of tannin or
pectin in the human body, for example, would be likely to have any effect on
drug bioavailability or that these compositions prolong the presence of drugs
generically.” (Id. at 14.)
According to the Examiner, Peloquin teaches that “the effect of food
on rifampicin pharmacokinetics, showing a prolongation of rifampicin, is
similar to that discussed by Salantinjints with the composition taught.”
(Non-Final Act. 9.) “Additionally, Rifampicin is taught by Peloquin to be
one of the three most important drugs for the treatment of tuberculosis.”
(Ans. 3.)
Peloquin discloses that “[a]ntacids had no effect on the absorption of
RIF; however, food significantly decreased Cmax and increased Tmax.
Therefore, RIF should be taken on an empty stomach whenever possible.”
(Peloquin 18.)

9 Siegler et al., Effect of Meals on Rifampicin Absorption, 2 LANCET 197
(1974).
10 Zent et al., Study of the effect of concomitant food on the bioavailability of
rifampicin, isoniazid, and pyrazinamide, 76 TUBERCLE LUNG DIS. 109
(1995).
11 Polasa et al., Effect of Food on Bioavailability of Rifampicin, 23 J. CLIN.
PHARM. 433 (1983).
12 Hagelund et al., Absorption of Rifampicin in Gastrectomized Patients, 58
SCAND. J. RESP. DIS. 241 (1977).
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Siegler discloses:
We have shown that 600 mg. of rifampicin taken with a meal results
in statistically significantly lower and later peak blood
concentrations. . . . The duration of exposure to a blood level above
the M.I.C. [minimal inhibitory concentration], is probably more
critical than the value of the peak concentration, so our findings
suggest that the effect of food is unlikely to influence the therapeutic
outcome unfavourably.
(Siegler 198.)
Zent discloses that “[t]he oral bioavilability of rifampicin and
isoniazid is likely to be optimal when these drugs are taken on an empty
stomach and when food is avoided for at least 3 hours after ingestion.”
(Zent 113.)
Polasa discloses “from our data it may be concluded that food appears
to delay the absorption as well as decrease the bioavailability of rifampicin,
although we have no direct evidence to elucidate the mechanisms involved.”
(Polasa 436.)
Hagelund discloses that “administration of rifampicin with food
resulted in delayed but not significantly lower peak concentrations. The
amount of rifampicin absorbed, as judged by the AUCs, was reduced but not
significantly so by administration with food.” (Hagelund 244.)
Although we agree with Appellants that Peloquin recommends that
RIF should be taken on an empty stomach when possible, we do not agree
with the conclusion that this would lead away from the use of a prolongation
solution. Moreover, other references cited in Peloquin indicate that “the
effect of food is unlikely to influence the therapeutic outcome unfavourably”
(Siegler 198). A reference is said to “teach away” from a claimed invention
only when it “suggests that the line of development flowing from the
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reference’s disclosure is unlikely to be productive of the result sought by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). That is not the
case here because, if anything, these references, taken as a whole, merely
illustrate the trade-offs that those of ordinary skill in this art would recognize
and routinely consider in designing formulations and for drug administration
protocols.
For example, Zent and Polasa suggest that taking rifampicin on an
empty stomach may be optimal, however, this does not mean that food
prevents sufficient absorption of rifampicin to be therapeutically effective.
As explained in Siegler, as well as Hagelund, getting the blood
concentrations of rifampicin above the minimal inhibitory concentration for
Mycobacterium tuberculosis is more important than obtaining the same peak
concentrations as those obtained when administering the compound on an
empty stomach. We therefore conclude that, on balance, the teachings of
Peloquin, Siegler, Zent, Polasa, and Hagelund would not dissuade the artisan
from combining rifampicin with food or a food substance, or from
formulating rifampicin into a sustained release composition.
Appellants contend that “Salatinjants patents are limited to the
prolongation of certain sulfa-type drugs and quinine . . . [and] do not
disclose rifampicin which is chemically non-analogous to the several drugs
disclosed in these patents.” (App. Br. 7.)
We are not persuaded by Appellants’ contention that Salatinjants ’952
is limited to the administration of a particular type or class of drug (see
Salatinjants ’952, claim 1). The Examiner recognizes “that the chemical
structures of the compounds are different,” but finds that the “problems
associated with the rifampicin [are similar] to those observed for the
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Salatinjants sulfa and cinchona alkaloid drugs based on short half-lives.”
(Ans. 3-4.) The Examiner concludes that, at the time the invention was
made, it would have been obvious to one of ordinary skill in the art to “have
considered the prolongation formulation of Salantinjants as an alternate
controlled release composition to achieve the desired rifampicin controlled
release.” (Ans. 8.) We agree with the Examiner. “[T]he mere substitution
of one element for another known in the field” is obvious when “the
combination must do more than yield a predictable result.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007) (citing United States v. Adams, 383
U.S. 39, 51-52.) Given the known benefit of the prolongation composition
disclosed by Salantinjants for antibacterial drugs, one of ordinary skill in the
art would have been motivated to at least try to use that composition with
rifampicin in order to achieve a similar prolongation benefit. KSR, 550 U.S.
at 421 (“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the
product not of innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might show that it
was obvious under § 103”).
Appellants contend that Lerner “does not disclose or teach anything
about rifampicin. . . [and] is limited to a pectin and tannin composition,
[and] lacks the several other compounds specified in the claim and does not
disclose or suggest any difference or benefit to be derived from the use of
ethanol over water or that the choice of solvent has any particular effect.”
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(App. Br. 14-15.) Similarly, Appellants assert that “Dunn does not mention
rifampicin.” (Id. at 15.)
We agree with the Examiner’s position that Appellants err in attacking
the references individually, as the rejection is based on a combination of
references (Ans. 3). See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). The references cannot be read in isolation, but for what they
teach in combination with the prior art as a whole. See id.
The Examiner correctly recognizes that “the Salatinjants compositions
are dissolved in water, in a total volume of 67ml (Drug No.1) or 316 ml
(Drug No. 1 [sic][)],” which are “amounts that bracket the instant recited
100 ml of 15% ethanol, [thus] rendering the 100 ml amount obvious as a
result of optimization within the volumes taught” (Non-Final Act. 6.) “The
law is replete with cases in which the difference between the claimed
invention and the prior art is some range or other variable within the
claims.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citations
omitted). “In cases involving overlapping ranges . . . even a slight overlap in
range establishes a prima facie case of obviousness.” In re Peterson, 315
F.3d 1325, 1329 (Fed. Cir. 2003). Moreover,
Selecting a narrow range from within a somewhat broader range
disclosed in a prior art reference is no less obvious than identifying a
range that simply overlaps a disclosed range. In fact, when . . . the
claimed ranges are completely encompassed by the prior art, the
conclusion is even more compelling than in cases of mere overlap. . . .
[A] prior art reference that discloses a range encompassing a
somewhat narrower claimed range is sufficient to establish a prima
facie case of obviousness.
(Id. at 1329-1330.) “These cases have consistently held that in such a
situation, the applicant must show that the particular range is critical,
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generally by showing that the claimed range achieves unexpected results
relative to the prior art range.” Woodruff, 919 F.2d at 1578.
We therefore agree with the Examiner’s position that it would have
been obvious to optimize the prolongation solution of Salatinjants ’952 to
arrive at the 100 ml (Non-Final Act. 6) as well as optimize the various
ingredients within the composition as suggested by the teaching of Lerner
that include liquid formulations having tannic acid in ethanol (see FF 5-7).
As noted by the Examiner:
While Lerner does teach what is effectively to [sic] ranges of
ethanol/water bracketing the recited 15% and tannic acid amounts
even higher than the instant recited tannic acid amount, Lerner
provided [a] teaching that higher levels of tannic acid from 0.08 g/67
or 0.08 g /316 ml in water, taught by Salatinjants, can be achieved by
using the preferred embodiment of Lerner, in ethanol water solutions.
(Ans. 11.) The Examiner takes the position that “[b]oth Lerner and Dunn
establish tannic acid (or tannic acid + pectin) are art recognized sustained
release agents for a broad group of drugs.” (Ans. 7, see also 8, 10.) The
Examiner explains that
[b]ecause modification of Salatinjants also requires a 10-fold higher
amount of tannic acid, relative to the amount of the other prolongation
composition components, Lerner is relied on to establish that tannic
acid (as well as the combination of tannic acid + pectin) is known in
the art as sustained release excipients. This is also established
independently by Dunn. (Argument over the purpose of tannic acid
during prosecution required the introduction of both Lerner and Dunn
to establish this generic applicability of the sustained release
characteristic of tannic acid is well known in the art.) Lerner also
demonstrates that significantly higher levels of tannic acid (from those
used by Salatinjants) may be dissolved in ethanol-water solutions.
The point is that because the tannic acid component of Salatinjants is
art-recognized as a sustained release excipient, and because higher
concentrations can be dissolved in ethanol water solutions, the skilled
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artisan would have been motivated by teachings of Lerner to increase
the amount of tannic acid in the Salatinjants prolongation formulation.
(Ans. 9-10.)
Here, Appellants have not shown any criticality or unexpected results
with respect to the 15% ethanol and 8% tannic acid in the recited
prolongation composition as claimed. Indeed, the Specification in reference
the prolongation solution of as recited in Examples 1 and 2 provides that
these “figures are approximations on the order of 0±10%.” (Spec. 4
(emphasis added), see also Summary of Invention.)
We recognize, but are not persuaded by, Appellants contention that
“prolongation in vivo is utterly unpredictable. To impute a property to
tannic acid and/or pectin as an all pharmacopeia prolongator applicable to
any or all or a range of structurally dissimilar drugs is simply fantasy.”
(Reply Br. 9-10.) The issue is not the general unpredictability of including
tannic acid and/or pectin in prolongation compounds, as those components
are already included in the composition taught by Salatinjants ’952. The
question is whether it would have been obvious to modify the Salatinjants
’952 composition to arrive at a 10 fold increase in tannic acid in 15%
ethanol. Appellants failed to provide persuasive argument or evidence to
rebut the Examiner’s conclusion that, based on the teachings of Salatinjants
’952, Lerner, and Singh, “the skilled artisan would have had a reasonable
expectation that increasing the relative amount of tannic acid from 0.08 g
taught by Salatinjants, to 10-fold higher, 0.8 g could be accomplished by
switching from water as solvent to using about 100 ml solution of 15%
ethanol.” (Ans. 11; see also FF 1-7.) We find no error in the Examiner’s
prima facie case. In affirming a multiple reference rejection under 35 U.S.C.
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§ 103, the Board may rely on fewer than all of the references relied on by the
Examiner in an obviousness rationale without designating it as a new ground
of rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1961).
On balance, we conclude that the preponderance of evidence relied
upon by Examiner supports a conclusion of obviousness. The rejection of
claim 1 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Salatinjants ’952, Singh, Peloquin, Lerner, Dunn, and Zanchi is affirmed.

II. The Issue: Obviousness-Type Double Patenting
Appellants contend that Salatinjants ’173 “adds nothing to the
rejection” (App. Br. 17).
Claims 1 and 2 of Salatinjants ’173 recite:
1. A composition adapted to prolong the residence time of drugs in the
circulating plasma of mammals including humans comprising about
48 parts by weight potassium hydrogen tartrate, about 8 parts by
weight tannic acid, about 94 parts by weight pectin, about 21 parts by
weight L-tyrosine, about 6 parts by weight hexanoic acid, and about
200 parts by weight 10% riboflavin.

2. The composition of claim 1 in the form of an aqueous solution.
(Salatinjants ’173, claims 1 and 2.)
Appellants reiterate the position that each individual reference does
not disclose the prolongation solution in conjunction with rifampicin
(App. Br. 17-19). “[P]atentability is determined on the totality of the record,
by a preponderance of evidence with due consideration to persuasiveness of
argument.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). As
discussed above (I.), we have found no error in the Examiner’s prima facie
case based on the combination Salatinjants ’952, Singh, Peloquin, Lerner,
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Dunn, and Zanchi. Appellants, however, present no additional arguments or
other persuasive evidence with respect to Salatinjants ’173 in combination
with the other cited references that would persuade us that the Examiner is in
error. Accordingly, we affirm the rejection of claim 1 on the grounds of
non-statutory obviousness-type double patenting.

SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over
Salatinjants ’952 in view of Singh, Peloquin, Lerner, Dunn and Zanchi.
We affirm the rejection of claim 1 on the grounds of non-statutory
obviousness-type double patenting over claims 1 and 2 of Salatinjants ’173,
in view of Salatinjants ’952, Singh, Peloquin, Lerner, Dunn and Zanchi.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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