WisTa Laboratories Ltd.

Patent Trials and Appeals Board

May 15, 2020

2019003948 (P.T.A.B. May. 15, 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.
14/929,111 10/30/2015 Claude Michel WISCHIK W1081.70003US00 1068
23628 7590 05/15/2020
WOLF GREENFIELD & SACKS, P.C.
600 ATLANTIC AVENUE
BOSTON, MA 02210-2206
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/15/2020 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):
Patents_eOfficeAction@WolfGreenfield.com
WGS_eOfficeAction@WolfGreenfield.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLAUDE MICHEL WISCHIK, JANET ELIZABETH RICKARD,
CHARLES ROBERT HARRINGTON, DAVID HORSLEY,
JOHN MERVYN DAVID STOREY, COLIN MARSHALL,
JAMES PETER SINCLAIR, and THOMAS CRAVEN BADDELEY
Appeal 2019-0039481
Application 14/929,111
Technology Center 1600
Before ULRIKE W. JENKS, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods of treating a disease of protein aggregation using reduced bis protic
acid salts of a diaminophenothiazine moiety. The Examiner rejected the
claims on the ground of obviousness-type double patenting. We held oral
argument on April 9, 2020. We have jurisdiction under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as WisTa
Laboratories Ltd. Appeal Br. 3.
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Application 14/929,111

2
We affirm one of the two pending obviousness-type double patenting
rejections, but designate our affirmance as a New Ground of Rejection.
CLAIMED SUBJECT MATTER
The Specification indicates that methylthioninium chloride (“MTC”),
which is also known as Methylene Blue, is a chloride salt that may be
considered to be an “oxidized form” of a phenothiazine. Spec. ¶¶ 37–38.
The Specification indicates that MTC is not itself taken up by human
erythrocytes, but rather is reduced before uptake. Id. at ¶ 40. As such, the
Specification indicates that it would be desirable to administer the reduced
form of MTC, to avoid the rate-limiting conversion step. Id. at ¶ 42. The
invention is therefore directed to “a class of compounds that may . . . be
considered to be in the ‘reduced form’ when considered in respect of MTC,
and which are surprisingly and unexpectedly stable.” Id. at ¶ 43.
Claims 3, 5, 7, 8, and 10–17 are on appeal, of which claims 3 and 7
are independent. Final Act. 2. Claims 3 and 7 are illustrative of the claimed
subject matter, and read:
3. A method of treating a disease of protein aggregation in a
subject in need thereof, wherein the protein is selected from
huntingtin, α-synuclein, and superoxide dismutase, the method
comprising administering to a subject with a disease of protein
aggregation, wherein the protein is selected from huntingtin, α-
synuclein, and superoxide dismutase, a therapeutically effective
amount of a bis protic acid salt compound of the following
formula:
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wherein:
each of R1 and R9 is independently selected from: -H,
C1-4alkyl, C2-4alkenyl, and halogenated C1-4alkyl;
each of R3NA and R3NB is independently selected from: -H,
C1-4alkyl, C2-4alkenyl, and halogenated C1-4alkyl;
each of R7NA and R7NB is independently selected from: -H,
C1-4alkyl, C2-4alkenyl, and halogenated C1-4alkyl; and
each of HX1 and HX2 is independently a protic acid, wherein
if any of HX1 or HX2 is a hydrohalic acid, then each is
independently selected from HCl and HBr
thereby inhibiting aggregation of huntingtin, a-synuclein, or
superoxide dismutase.
7. A method of treating Huntington’s disease, Parkinson’s
disease, amyotrophic lateral sclerosis, dementia with Lewy
bodies, or multiple system atrophy in a subject in need thereof,
the method comprising administering to a subject with
Huntington’s disease, Parkinson’s disease, amyotrophic lateral
sclerosis, dementia with Lewy bodies, or multiple system
atrophy a therapeutically effective amount of a bis acid protic
salt compound of the following formula:

wherein:
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each of R1 and R9 is independently selected from: -H,
C1-4alkyl, C2-4alkenyl, and halogenated C1-4alkyl;
each of R3NA and R3NB is independently selected from: -H,
C1-4alkyl, C2-4alkenyl, and halogenated C1-4alkyl;
each of R7NA and R7NB is independently selected from: -H,
C1-4alkyl, C2-4alkenyl, and halogenated C1-4alkyl; and
each of HX1 and HX2 is independently a protic acid, wherein
if any of HX1 or HX2 is a hydrohalic acid, then each is
independently selected from HCl and HBr
thereby treating the subject’s Huntington’s disease, Parkinson’s
disease, amyotrophic lateral sclerosis, dementia with Lewy
bodies, or multiple system atrophy.
Appeal Br. 23–24 (Claims Appendix).
REJECTIONS
Claims 3, 5, 7, 8, and 10–17 stand rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1–9 of US Patent 8,278,298 (the “’298 Patent”) in view of Wirths2
and Giorgini.3 Final Act. 2–3.
Claims 3, 5, 7, 8, and 10–17 stand rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1–15 of US Patent 8,263,589 (the “’589 Patent”). Final Act. 6.

2 Wirths et al., α-Synuclein, Aβ and Alzheimer’s Disease, 27 Progress in
Neuro-Psychopharmacology & Biological Psychiatry 103–108 (2003).
3 Giorgini et al., Connecting the Dots in Huntington’s Disease with Protein
Interaction Networks, 6 Genome Biology 210:1–6 (2005).
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OPINION
Obviousness-Type Double Patenting Over Claims 1–9 of the ’298 Patent in
View of Wirths and Giorgini
The Examiner found that both the pending claims and claims 1–9 of
the ’298 Patent are directed to “administering the same compounds to
patients with Alzheimer’s disease,” and that the “[t]he core structure of the
compound is the same and thus will have the same properties.” Ans. 3, 4.
The Examiner additionally found that the ’298 Patent claims salts of this
core structure, while its specification teaches hydrobromide and
hydrochloride salts. Ans. 6, 7 (citing ’298 Patent at 18:33–39).
With respect to the recited methods, the Examiner stated:
Alpha synuclein (alpha-SN) is a ubiquitous protein that is
especially abundant in the brain and has been postulated to play
a central role in the pathogenesis of Parkinson’s disease (PD),
Alzheimer’s disease, and other neurodegenerative disorders,
therefore one of ordinary skill in the art would have been
motivated to administer the patented compounds for the
treatment of tau-tau and or protein aggregation with a
reasonable expectation of success.
Also the proteins overlap . . . in Alzheimer’s;
Parkinson’s, Lewy bodies and Huntingtin’s disease (see Wirths
et al) and Giorgini et al. Claim 8 [of the reference patent]
specifically recites the overlapping disease state as the instant
claims.
Ans. 4. The Examiner additionally stated: “[t]he claims of the patent[]
clearly teach Lewy body disease, and so if Lewy body disease is a disease of
the protein aggregation, then the claims must have been obvious over the
patented claims.” Ans. 8; see also Ans. 9 (asserting that the ’298 claims and
pending claims are both directed to Lewy body disease).
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We determine that the Examiner has established prima facie
obviousness-type double patenting of the pending claims over claims 1–9 of
the ’298 Patent. The compounds recited in the pending claims are
admittedly a subgenus of the compounds recited in the ’298 Patent claims.
Appeal Br. 8. For example, claim 3 of the ’298 Patent recites a genus of
phenothiazines of formula (I), which encompasses both oxidized and
reduced forms of the compounds, as well as pharmaceutically acceptable
salts thereof. ’298 Patent 43:10–44:8. Claim 6 of the ’298 Patent narrows
formula (I) to compounds and pharmaceutically acceptable salts thereof
wherein R5 is hydrogen (i.e., the core compound is in reduced form). Id. at
44:33. The pending claims recite the same core structure encompassed by
claim 6 of the ’298 Patent, but differ in claiming a more limited selection of
salts. Compare ’298 Patent at 44:33 with Appeal Br. 23–25 (Claims
Appendix). Specifically, the pending claims are limited to bis protic acid
salts, whereas the ’298 Patent claims are directed to any pharmaceutically
acceptable salt. See id. Thus, with respect to options for the claimed salt,
the subgenus recited in the pending claims is more limited than that of the
genus recited in reference claim 6.
The ’298 Patent claims are directed to a method for the prophylaxis of
Alzheimer’s disease and Lewy body disease (among other diseases),
comprising “administering to a subject in need thereof an effective amount
of an agent which modulates or inhibits tau-tau association and which does
not inhibit tau-tubulin binding.” See, e.g., ’298 Patent 43:1–7. Pending
claim 3 is directed to a method of treating a disease of protein aggregation,
wherein the protein is selected from α-synuclein (among other proteins).
Appeal Br. 23 (Claims Appendix). Aggregation of α-synuclein is linked to
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many neurodegenerative diseases, including the Lewy body variant of
Alzheimer’s disease. Wirths 104. Pending claim 7 recites a method of
treating dementia with Lewy bodies (among other diseases). Appeal Br. 23–
24 (Claims Appendix). Thus, the two sets of claims differ in that the ’298
Patent claims are directed to prophylaxis of Lewy body disease (among
other diseases) by modulating or inhibiting tau-tau association, whereas the
pending claims are directed to treatment of a disease of protein aggregation
by inhibiting aggregation of α-synuclein (among other proteins) (pending
claim 3), or Lewy body disease (among other diseases) (pending claim 7).
The doctrine of obviousness-type double patenting is designed to
prevent an inventor from securing a second, later-expiring patent for the
same invention (and obvious variants thereof) claimed in an earlier,
commonly-owned patent. AbbVie Inc. v. Mathilda and Terrence Kennedy
Inst. of Rheumatology Trust, 764 F.3d 1366, 1373 (Fed. Cir. 2014). The
obviousness-type double patenting analysis is comparable to that under 35
U.S.C. § 103, and requires consideration of whether one of ordinary skill
would have considered the examined claims merely an obvious variation of
an invention claimed in an earlier patent. See In re Braat, 937 F.2d 589,
592–93 (Fed. Cir. 1991).
In view of the overlap between the pending claims and reference
claims with respect to both the recited compounds and methods of use, we
determine that a prima facie case of obviousness exists. “It is a general rule
that merely discovering and claiming a new benefit of an old process cannot
render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990) (affirming rejection of claims to a purportedly “new use” of
maintaining vegetables under certain conditions to prevent fungal growth as
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obvious where prior art disclosed maintaining vegetables under the same or
similar conditions to prevent deterioration). Here, both sets of claims
overlap with respect to at least Lewy body disease (α-synuclein being linked
to Lewy body disease, see Wirths 104), and the claimed “effective amount”
of the compounds for performing the respective claimed methods overlap.
Specifically, according to the ’298 Patent, effective amounts of the
compounds to modulate or inhibit tau-tau association in connection with
Lewy body disease include about 50–700 mg daily. ’298 Patent 20:31–35;
see also Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 689 F.3d 1368,
1378‒79 (Fed. Cir. 2012) (specification of reference patent may be
considered to the extent necessary to construe its claims). According to the
pending application, effective amounts of the compounds to practice the
claimed methods include about 300–400 mg daily. Spec. ¶¶ 264–66. Thus,
according to these teachings, practicing the method of the ’298 Patent claims
at the overlapping dosages of about 300–400 mg daily would not only
modulate or inhibit tau-tau association according to the ’298 Patent claims,
but would also inhibit aggregation of α-synuclein (as recited in pending
claim 3), and treat dementia with Lewy bodies (as recited in pending
claim 7).
Appellant argues that there is no evidence of record that would
suggest to a skilled artisan that a compound useful for treating a tau-tau
aggregation disease would impact aggregation of the proteins recited in
pending claim 3 or the diseases recited in pending claim 7. Appeal Br. 19.
We are not persuaded by this argument. Given the overlap in dosages
discussed above, practicing the method of the ’298 Patent claims at the
overlapping dosages would not only modulate or inhibit tau-tau association
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according to the ’298 Patent claims, but would also inhibit aggregation of α-
synuclein (as recited in pending claim 3), and treat dementia with Lewy
bodies (as recited in pending claim 7). See In re Woodruff, 919 F.2d at
1578.
Appellant further argues that “[t]he Examiner maintains, without
scientific basis, that preventing tau-tau association (as claimed in the ’298
patent) is the same as treating diseases involving aggregation of huntingtin,
α-synuclein, and superoxide dismutase.” Reply Br. 8. Appellant asserts that
“preventing tau-tau aggregation from occurring in the first place is distinct
from treating (i.e., breaking up) aggregates of different proteins: huntingtin,
α-synuclein, and superoxide dismutase.” Id.
We are not persuaded by this argument because contrary to
Appellant’s suggestion, the ’298 Patent claims are not limited to
“preventing” tau-tau aggregation. Rather, the claims encompass both
“modulat[ing]” and “inhibit[ing]” tau-tau association. ’298 Patent 43:2–7.
Modulating tau-tau aggregation in a subject in need thereof suggests that
aggregation has already happened. Thus, we do not agree with Appellant
that there is a material difference between the reference patent claims, which
recite prophylaxis of Alzheimer’s disease or Lewy body disease (among
other diseases) by administering “an effective amount of an agent which
modulates or inhibits tau-tau association,” and the pending claims, which
recite administering a therapeutically effective amount of the claimed agents
to inhibit aggregation of α-synuclein (claim 3) or to treat dementia with
Lewy bodies (claim 7).
Appellant additionally argues that the compounds recited in the
pending claims and in the ’298 Patent are not the same, because the
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presently claimed compounds “require a special process of synthesis” that is
not disclosed in the ’298 Patent and “was not available in the prior art.”
Appeal Br. 18; Reply Br. 4, 8. We are not persuaded by this argument. On
this record, Appellant has not persuasively established that the presently
claimed compounds “require a special process of synthesis” that is not
disclosed in the ’298 Patent or prior art. Attorney argument is “no substitute
for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir.
1989). Thus, Appellant has not established on this record that the salt
products recited in the claimed treatment method were not enabled by the
’298 Patent or prior art.
Appellant further argues that the mere fact that the ’298 Patent claims
encompass (or dominate) the currently-claimed subgenus does not alone
support an assertion of double patenting, because here, the claimed
compounds are “a patentably distinct sub-genus of compounds that possess
unique properties and structures distinct from the other compounds in the
genus claimed in the reference patents.” Reply Br. 4; see also id. at 6–7;
Appeal Br. 8–9 (arguing that the claimed bis protic acid salts possess
“unique physical and chemical properties that make the claimed compounds
unexpectedly superior in terms of stability and clinical utility”).
Specifically, Appellant asserts differences between certain compounds
recited in the claimed genus as compared to methylene white (“MNT”) and
MTC, including with respect to UV spectra, IR spectra, NMR spectra, X-ray
crystal structure, polymorph profile, solubility, stability, pKa, in vivo uptake,
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food effect, and tolerability. Appeal Br. 10–15 (citing Storey and Wischik
Declarations4).
On this record, we are not persuaded that Appellant has demonstrated
unexpected results. “[T]he burden of showing unexpected results rests on
[the party] who asserts them.” In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). It is not enough for Appellant to merely show differences between
the compounds. Rather, Appellant must show that the differences are
unexpected. See In re Freeman, 474 F.2d 1318, 1324 (CCPA 1973); Pfizer,
Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (“[B]y definition,
any superior property must be unexpected to be considered as evidence of
non-obviousness.”).
Here, Appellant argues that “under normal circumstances, formulating
a given compound as a salt would not be expected to significantly alter the
properties of the active compound being formulated” (Appeal Br. 9 (citing
Storey Declaration ¶ 8)), and that “salts usually do not significantly alter the
structure or properties of a compound” (Reply Br. 7). Based on this
premise, Appellant argues that “it is entirely unexpected that the claimed bis
protic acid salts (i.e., ‘LMTX’ compounds) possess chemical and clinical
properties that are significantly different compared to the non-salt form of
the active moiety (i.e., leucomethylthioninium or ‘LMT’) or a salt form of
the oxidized form of the core structure (e.g., methylene blue or
methylthioninium chloride or ‘MTC’).” Appeal Br. 10.

4 Declaration Under 37 C.F.R. § 1.132 by Professor John Storey, Feb. 9,
2018 (“Storey Declaration”); Declaration Under 37 C.F.R. § 1.132 by
Professor Claude Wischik, Feb. 9, 2018 (“Wischik Declaration”).
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In support of the premise that “salts usually do not significantly alter
the structure or properties of a compound,” Appellant cites the FDA’s
Orange Book as stating that “[d]rug products are considered
pharmaceutical alternatives if they contain the same therapeutic moiety,
but are different salts.” Appeal Br. 9–10 (quoting Nomenclature, excerpt
from the FDA Orange Book, available at https://www.fda.gov/ohrms/
dockets/ac/05S/briefing/2005-4137B 1_07 Nomenclature.pdf) (emphasis
added). The Orange Book Preface, however, clarifies that “pharmaceutical
alternatives” are regarded as different active ingredients, which are not
therapeutically equivalent:
Different salts . . . of the same active moiety are regarded as
different active ingredients. For the purpose of this publication,
products containing such different active ingredients are
considered pharmaceutical alternatives and, thus, not
therapeutically equivalent.
Orange Book Preface, available at https://www.fda.gov/drugs/development-
approval-process-drugs/orange-book-preface. This classification of different
salts of the same active moiety as different active ingredients that are not
therapeutically equivalent undercuts Appellant’s premise that salts of a
compound are expected to have the same physical and chemical properties
as the core compound.
Further, the Berge5 publication of record teaches that salts can in fact
impart unique properties to the parent compound. Berge 1 (“Choosing the
appropriate salt . . . can be a very difficult task, since each salt imparts

5 Berge et al., Pharmaceutical Salts, 66(1) J. Pharmaceutical Sciences 1–17
(1977) (listed on Information Disclosure Statement submitted on February 9,
2018).
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unique properties to the parent compound.”) Berge teaches that salt
formation can affect a variety of properties:
Various salts of the same compound often behave quite
differently because of the physical, chemical, and
thermodynamic properties they impart to the parent compound.
For example, a salt’s hydrophobicity and high crystal lattice
energy can affect dissolution rate and, hence, bioavailability.
. . .
The salt form is known to influence a number of
physicochemical properties of the parent compound including
dissolution rate, solubility, stability, and hygroscopicity. These
properties, in turn, affect the availability and formulation
characteristics.
Berge 2, 5.
We give more weight to the statements in the Orange Book Preface
and Berge suggesting that salt formation can change the properties of the
base compound, than we do to Dr. Storey’s statement that “the formation of
a salt is not expected to fundamentally alter the structure and properties of
the underlying API.” Storey Decl. ¶ 8. Dr. Storey’s statement is supported
by neither persuasive reasoning nor citation to documentary evidence. See,
e.g., Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“In giving
more weight to prior publications than to subsequent conclusory statements
by experts, the Board acted well within [its] discretion.”); In re Am. Acad. of
Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is
entitled to weigh the declarations and conclude that the lack of factual
corroboration warrants discounting the opinions expressed in the
declarations.”). Accordingly, on this record, Appellant has not demonstrated
that the differences it has shown between compounds that fall within the
claimed genus and LMT and MTC would have been unexpected.
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Appellant additionally argues that “[t]he same Examiner has
previously considered almost exactly the same fact pattern when allowing
the ‘grandparent’ (U.S. Parent 8,710,051) of the present application.” Reply
Br. 9; Appeal Br. 18–19. We are not persuaded by this argument, because as
the Examiner stated, every application is treated on its own merits. Ans. 10.
Finally, Appellant states: “[b]ecause the Examiner has repeatedly
demonstrated an unwillingness to consider the evidence and appropriately
apply the law, Appellant requests that the Board enter a finding of no ODP
in fact, removing the necessity for further evidentiary consideration of the
ODP rejections over the ’298 and ’589 patents.” Appeal Br. 21. Based on
our affirmance of the obviousness-type double patenting rejection over
claims 1–9 of the ’298 Patent in view of Wirths and Giorgini, we see no
basis to enter “a finding of no ODP in fact.”
Because our statement of the rejection of claims 3, 5, 7, 8, and 10–17
for obviousness-type double patenting over claims 1–9 of the ’298 Patent in
view of Wirths and Giorgini differs somewhat from that of the Examiner, we
designate this rejection as a New Ground under 37 C.F.R. § 41.50(b) to
provide Appellant with a full and fair opportunity to react to the rejection.

Obviousness-Type Double Patenting Over Claims 1–15 of the ’589 Patent
The Examiner found that both the pending claims and claims 1–15 of
the ’589 Patent are directed to “administering the same compounds” to
patients with protein aggregation disorders, and therefore “one of ordinary
skill in the art would have been motivated to administer the patented
compounds for the treatment of tau and or protein aggregation with a
reasonable expectation of success using the compounds.” Ans. 4–5.
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We determine that on this record, the Examiner has not established a
prima facie case of obviousness-type double patenting, because the
Examiner has not established that the pending claims and the ’589 Patent
claims recite administering the “same compounds.” The pending claims
recite a genus of bis salts of certain phenothiazine compounds in reduced
form, whereas the claims of the ’598 Patent recite a genus of salts and mixed
salts of the same phenothiazine core compound in oxidized form. Compare
central nitrogen in the structure recited in pending claim 3 with central
nitrogen in structure (4) recited claim 1 of the ’598 Patent. Accordingly, the
compounds are not the “same,” and the Examiner has not articulated a
rationale as to why using the reduced compounds would have been obvious
in view of the methods of using the oxidized compounds recited in the ’589
Patent claims. Cf. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
(“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.”).
Accordingly, we reverse the obviousness-type double patenting
rejection over claims 1–15 of the ’589 Patent.
CONCLUSION
We affirm the rejection of claims 3, 5, 7, 8 and 10–17 on the ground
of nonstatutory obviousness-type double patenting over claims 1–9 of the
’298 Patent in view of Wirths and Giorgini, but designate our affirmance of
as a New Ground of Rejection.
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We reverse the rejection of claims 3, 5, 7, 8 and 10–17 on the ground
of nonstatutory obviousness-type double patenting over claims 1–15 of the
’589 Patent.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed New
Ground
3, 5, 7, 8,
10–17
Obviousness-type
double patenting over
claims 1–9 of US
Patent 8,278,298 in
view of Wirths and
Giorgini
3, 5, 7, 8,
10–17
3, 5, 7, 8,
10–17
3, 5, 7, 8,
10–17
Obviousness-type
double patenting over
claims 1–15 of US
Patent 8,263,589
3, 5, 7, 8,
10–17

Overall
Outcome:
3, 5, 7, 8,
10–17
3, 5, 7, 8,
10–17
TIME PERIOD FOR RESPONSE
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
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(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .
Should Appellant elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
AFFIRMED; 37 C.F.R. § 41.50(b)