Ex Parte Wu et al

Patent Trials and Appeals Board

Apr 10, 2019

14037528 - (D) (P.T.A.B. Apr. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/037,528 09/26/2013
51957 7590 04/12/2019
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
CindyW. Wu
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.
18970(0CU) 7356
EXAMINER
DICKINSON,PAUL W
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
04/12/2019 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):
patents_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED ST ATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CINDY W. WU, MICHAEL R. ROBINSON,
JAMES A. BURKE, and PAT RICK M. HUGHES
Appeal2018-000999
Application 14/037,528
Technology Center 1600
BeforeJEFFREYN. FREDMAN,ELIZABETHA. LAVIER, and
T AWEN CHANG, Administrative Patent Judges.
FRED MAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeaP, 2 under 35 U.S.C. § 134 involving claims to an
extruded biodegradable intraocular implant comprising a biodegradable
polymer matrix and a protein. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affrrm-in-partbut
designate our affrrmance as a new ground of rejection.
1 Appellants identify the Real Party in Interest as Allergan, Inc. (App. Br. 3).
2 We have considered the Specification of Sept. 26, 2013 ("Spec."); Final
Office Action of Sept. 8, 2016 ("Final Action"); Appeal Brief of May 8,
2017 ("Br."); and Examiner's Answer of Sept. 7, 2017 ("Ans.").
Appeal 2018-000999
Application 14/037,528
Statement of the Case
Background
"Biodegradable compositions, such as intraocular implants, capable of
delivering therapeutic levels of functional protein for extended periods could
be extremely useful for the treatment of ocular disease," (Spec. 1 :26 to 2:2).
However, "for macromolecules, such as proteins, that are cleared out via the
aqueous humor, the vitreal half-life is short relative to the duration of
therapy" (Spec. 2:16-17). In addition to "the discomfort and time associated
with frequent injections, direct intraocular injection can involve certain risks
to the patient, including retinal detachment, damage to the lens, and
infection" (Spec. 2:4---6).
The Specification teaches "a biodegradable drug delivery system
(DDS) that can release a therapeutically effective amount of biologically
active protein in vivo for one month or more, two months or more, or three
months or more" (Spec. 2:26-28).
The Claims
Claims 1-14 are on appeal. Claim 1 is representative and reads as
follows:
1. An extruded biodegradable intraocular implant
comprising a biodegradable polymer matrix and a protein
associated with the biodegradable polymer matrix, wherein the
biodegradable polymer matrix comprises a first poly(D,L-
lactide-co-glycolide) and a second poly(D,L-lactide-co-
glycolide ), the frrst poly(D,L-lactide-co-glycolide) having an
ester end group and a D,L-lactide:glycolide ratio of about
75:25, and the second poly(D,L-lactide-coglycolide) having an
acid end group and a D,L-lactide:glycolide ratio of about 50:50,
wherein the implant provides continuous release of the protein
in a biologically active form for about 90 days after placement
of the implant in an eye of a mammal.
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The Rejections
A. The Examiner rejected claims 1-3 and 7-14under 35 U.S.C. § 103(a)
as obvious over Lyons 3 (Ans. 2--4).
B. The Examiner rejected claims 1-14under35 U.S.C. § 103(a)as
obvious over Lyons and Chang4 (Ans. 4).
A. 35 US. C. § 103(a) over Lyons
The Examiner finds Lyons teaches "an extruded (paragraph 19)
biodegradable intraocular implant (paragraph 26) comprising a
biodegradable polymer matrix and a therapeutic agent associated with the
biodegradable polymer matrix" (Ans. 2). The Examiner fmds that Lyons
teaches the polymer matrix is composed of a poly(D ,L-lactide-co-glycolide)
(id.). The Examiner fmds Lyons teaches "continuous release of the
therapeutic agent in a biologically active form for about 90 days after
placement of the implant in an eye of a mammal" (id.). The Examiner fmds
that Lyons teaches therapeutic agents including "cytokines (which are
proteins), growth factors ( which are proteins), and a VEGF inhibitor ( which
is a protein) (paragraph39)" (id.).
The Examiner acknowledges that Lyons does not teach the precise
blend of the glycolide polymers, but fmds the blend obvious because Lyons
"suggests this blend when it teaches that these two polymers may separately
be used in the invention (paragraphs 60, 128, and 137) and thatthe polymers
may be used in combination (paragraph 16)" ( Ans. 3 ).
3 Lyons et al., US 2010/0311808 Al, published Dec. 9, 2010.
4 Chang et al., US 2011/0034448 Al, published Feb. 10, 2011.
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Application 14/037,528
Appellants identify three reasons for nonobviousness over Lyons,
including:
1) Applicants' claimed invention is directed to delivering
proteins to treat disease. Lyons is concerned with preventing
protein expression by delivering siRN As to stop protein
expression to treat disease. Lyons does not teach or suggest
delivery of proteins to treat disease;
2) Lyons does not teach or suggest the use offrrst and second
poly(D, L-lactide-coglycolide) copolymers as claimed by
applicants; and,
3) Lyons teaches delivery of siRNA nucleotides, which are
ribonucleic acids and very different compounds than
proteins, which are comprised of amino acid chains. Due to
these differences, the release kinetics would differ
considerably and very different polymer systems would be
used in applicants' invention than taught in Lyons.
(Br. 13).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that Lyons
suggests the use of therapeutic proteins and copolymers as required by the
claims?
Findings of Fact (FF)
1. Lyons teaches "new drug delivery systems, and methods of
making and using such systems, for administering siRNA molecules to an
eye, for example, to achieve one or more desired therapeutic effects" (Lyons
,r 14).
2. Lyons teaches "[i]ntraocular drug delivery systems in
accordance with the disclosure herein comprise a therapeutic component and
a drug release sustaining component associated with the therapeutic
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Application 14/037,528
component. The therapeutic component comprises at least one siRNA
molecule, and the drug release sustaining component comprises a
biodegradable polymer" (Lyons ,r 15).
3. Lyons teaches the "polymeric component of the present
systems may comprise a polymer and/or a copolymer and/or a block co-
polymer selected from the group consisting of poly-lactic acid (PLA), poly-
glycolic acid (PGA), poly-lactide-co-glycolide (PLGA) ... collagen ... and
combinations thereof' (Lyons ,r 16).
4. Lyons teaches the"% of poly lactic acid in the poly lactic acid
polyglycolic acid (PLGA) copolymer can be 0-100%, preferably about 15-
85%, more preferably about 35-65%. In some systems, a 50/50 PLGA
copolymer is used" (Lyons ,r 70).
5. Lyons teaches:
The polymers chosen for the implants can be obtained from
Boehringer Ingelheim or Purac America, for example.
Examples of polymers include: RG502, RG752, R202H,R203
and R206, and Purac PDLG (50/50). RG502 is (50:50)
poly(D,L-lactide-co-glycolide), RG752 is (75:25) poly(D,L-
lactide-co-glycolide), R202H is 100% poly(D,L-lactide) with
acid end group or terminal acid groups, R203 and R206 are
both 100% poly(D, L-lactide). Purac PDLG (50/50) is (50:50)
poly(D,L-lactide-co-glycolide ).
(Lyons ,r 137).
6. Lyons teaches the "biodegradable polymer matrix of the present
systems may comprise a mixture of two or more biodegradable polymers.
For example, the system may comprise a mixture of a first biodegradable
polymer and a different second biodegradable polymer. One or more of the
biodegradable polymers may have terminal acid groups" (Lyons ,r 71 ).
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7. Lyons teaches that "[i]n certain embodiments, the
macromolecule therapeutic agent is an siRNA having at least one property
selected from the group consisting of anti-angiogenesis, ocular hemorrhage
treatment, non-steroidalanti-inflammatory, growth factor(e.g. VEGF)
inhibitor, growth factor, cytokines and antibiotics" (Lyons ,r 39).
8. Lyons teaches "the therapeutic component can be released into
the eye for a time period from about ninety days to about one year after the
system is placed in the interior of an eye" (Lyons ,r 72).
9. Lyons teaches in "addition to the therapeutic agent ... the
systems may also include one or more additional ophthalmically acceptable
therapeutic agents. For example, a system may include ... one or more
antiviral agents ... Examples of antiviral agents include interferon gamma"
(Lyons ,r,r 84, 92).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Analysis
Claim 1
Biologically active protein
Appellants contend"[ n ]owhere in Lyons is there a teaching of
delivering proteins for the treatment of disease" (App. Br. 13). Appellants
contend "one of ordinary skill would know that siRNAs are not growth
factors but are ribonucleotide segments used for gene silencing" (App. Br.
15). Appellants also contend there is "absolutely no teaching at all in Lyons
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of delivery of collagen, only that collagen can be used as a polymer which
biodegrades to release siRNAs" (App. Br. 16).
We agree that Appellants are entirely correct that siRNAs are not
proteins; that paragraph [39] of Lyons refers solely to siRNAs and not to
proteins; and that the collagen referred to in paragraph [16] of Lyons is not a
biologically active as required by claim 1 (see FF 3, 7).
However, Lyons also teaches that in addition to the siRNA, the
intraocular delivery system may include additional therapeutic agents,
including interferon gamma (FF 9). Interferon gamma is a protein with 144
amino acids that Lyons identifies as having antiviral activity (FF 9).
Therefore, Lyons does suggest an intraocular implant designed to
therapeutically release a combination of siRN A and interferon gamma (FF 1,
9). Because claim 1 uses the open transition clause "comprising," claim 1 is
reasonably interpreted as encompassing compositions that deliver both a
protein such as interferon gamma, along with other therapeutic agents such
as siRNA. See Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322,
1327 (Fed. Cir. 1999) (The transitional term "comprising" is "inclusive or
open-ended and does not exclude additional, unrecited elements or method
steps.").
Because we rely on portions of Lyons not identified by the Examiner
and our reasoning regarding the protein component of the intraocular
implant of Lyons differs from that of the Examiner, we will designate this
affirmance as a new ground of rejection in order to permit Appellants a fair
opportunity to address this reasoning.
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Biodegradable polymer matrix
Appellants contend"[ w ]hile Lyons mentions in paragraph 26 that
there may be 'one or more copolymers' and paragraph 70 teaches a single
copolymer of glycolic acid and lactic acid, there is no teaching in Lyons of
mixtures of copolymers of glycolic and lactic acid" (Br. 18). Appellants
contend that
Paragraph 137 [ofLyons] states: "RG502 is (50:50)poly(D,L-
lactide-co-glycolide), RG752 is (75:25) poly(D,L-lactide-co-
glycolide) ... " RG502 is a single copolymer with a 50:50 ratio
ofD-lactide-co-glycolide and L- lactide-co-glycolide. RG752 is
a single copolymer with a 75:25 ratio ofD-lactide-co-glycolide
and L- lactide-co-glycolide. These are taught as separate
polymer systems and their combination is never taught or
suggested in paragraph 13 7. There is no mixture of the
copolymers taught in paragraph 137 of Lyons.
(Br. 17). Appellants contend that"[ o ]ne of ordinary skill in the art would
know that proteins and siRNAs are vastly different compounds with vastly
different properties. Consequently, how the polymers are blended to release
siRNAs would involve very different considerations than how polymers are
blended to release proteins" (App. Br. 20).
We find this argument unpersuasive. First, as Appellants
acknowledge, Lyons teaches both of the poly(D,L-lactide-co-glycolide)
polymers used to form the implant, the RG502 with a 50:50 ratio and the
RG752 with a 75:25 ratio (FF 5). Second, Lyons teaches that polymers can
be combined, specifically teaching the "biodegradable polymer matrix of the
present systems may comprise a mixture of two or more biodegradable
polymers. For example, the system may comprise a mixture of a first
biodegradable polymer and a different second biodegradable polymer" (FF
6). Thus, Lyons directly suggests that the system may be composed of two
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different polymers such as the RG502 and RG752 (FF 5, 6). Given this
teaching by Lyons, we fmd that the combination of polymers represents a
"combination of familiar elements according to known methods" and "is
likely to be obvious when it does no more than yield predictable results."
KSR, 550U.S. at 416.
We also fmd Appellants' argument that the polymer blends would
necessarily differ based on the presence of siRN As or proteins unpersuasive
because this statement lacks any evidentiary basis, and solely represents
attorney argument. " [ A ]ttomey argument [is] not the kind of factual
evidence that is required to rebut a prima facie case of obviousness." In re
Geisler, 116F.3d 1465, 1470(Fed. Cir. 1997).
Claim2
Appellants contend "there is no teaching or suggestion in Lyons of an
implant or a combination of two copolymers wherein the weight-to-weight
ratio of frrst poly(D,L-lactide-coglycolide) to second poly(D,L-lactide-co-
glycolide) is about 90:10" (App. Br. 21). Appellants also contend that:
By blending RG753S and RG502H at a ratio of90 to 10
(Formulation No. 2, corresponding to claim 2), the PLGA-
bevacizumab implant shows an increased duration of release,
from 1 month to 2 months. This is a significant, profound and
unexpected result which increased the duration of release by
100% and corresponds to claims 1-3.
(App. Br. 22-23).
We fmd these arguments unpersuasive. As to the issue of a
suggestion to blend the polymers to a particular ratio, Lyons suggests that
the polymers may be blended (FF 6), render the particular ratio prima facie
obvious as an optimizable variable. When we consider the obviousness
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position with the asserted secondary consideration of unexpected results, we
are not persuaded, for two reasons.
First, the unexpected results are not identified as unexpected. That is,
other than in Appellants' brief, the Specification does not state that the
results of the 90:10 ratio of polymers was unexpected. See In re Klosak, 455
F.2d 1077, 1080 (CCPA 1972) ("[I]t is not enough to show that results are
obtained which differ from those obtained in the prior art: that difference
must be shown to be an unexpected difference"). It is only in the Attorney's
argument that the results are identified as unexpected (see Br. 22-23). See
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in
a brief cannot take the place of evidence.").
Second, the results are not commensurate in scope with the scope of
claim 1. The results shown are limited to release of a single particular
protein, while claim 1 reasonably encompasses any protein desirable for
ocular treatment, and certainly any protein desirable for treatment of the four
different conditions recited in claim 3. Unexpected results must be
"commensurate in scope with the degree of protection sought by the claimed
subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005).
Claim 3
Appellants contend "[a]s to claim 3, Lyons does not teach or suggest
delivering proteins or antibodies through biocompatible ocular implants to
treat disease/ conditions listed in claim 3 but instead teaches delivery of
siRNAs to either block or inhibit protein synthesis" (App. Br. 21 ).
We find this argument persuasive. The Examiner does not identify
any teaching in Lyons of a protein designed to be included in the ocular
implant, that would treat any of the four conditions recited in claim 3. We
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Application 14/037,528
note that there is no evidence that the interferon gamma protein recited by
Lyons as an antiviral protein would function to treat any of the four
conditions recited in claim 3. We therefore reverse this rejection of claim 3.
Claims 7-13
Appellants do not present any separate arguments for these claims
relative to claim 1, so these claims fall with claim 1. See 37 C.F.R.
§ 4I.37(c); see also In re Dance, 160 F.3d 1339, 1340 n.2 (Fed. Cir. 1998).
Claim 14
Appellants contend "[t]here is nothing in Lyons which teaches or
suggests the step of 'blending the dry powder with at least two poly(D,L-
lactide-co-glycolide) copolymers to form a mixture wherein one of the
copolymers has an ester end group and the other copolymer has an acid end
group'" (App. Br. 22).
We find this argument persuasive because the Examiner identifies no
teaching from Lyons nor other reason for blending a copolymer that has an
ester end with the copolymers as a dry powder. And while Lyons does
mention the use of an acid end group (FF 6), the Examiner does not identify
a teaching or evidence that one of the cited copolymers of Lyons had an
ester end group. The Examiner has the initial burden of establishing a prima
facie case obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that Lyons suggest the use of therapeutic proteins and
copolymers as required claims 1, 2, and 7-13.
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A preponderance of the evidence of record does not support the
Examiner's conclusion that Lyons suggest the use of therapeutic proteins
and copolymers as required by claims 3 and 14.
B. 35 US. C. § 103(a) over Lyons and Chang
The Examiner relies upon Lyons as discussed above but
acknowledges that "Lyons fails to teach an antibody that binds vascular
endothelial growth factor" (Ans. 4).
The Examiner fmds that "Chang is directed to biocompatible
intraocular drug delivery systems and is therefore in the same field of
invention as Lyons. Chang teaches antibodies that bind vascular endothelial
growth factors (paragraphs 3 5, 3 7) are advantageously used to treat posterior
ocular conditions such as macular degeneration (paragraph 60)" (Ans. 4).
The Examiner fmds it obvious to "incorporate antibodies that bind
vascular endothelial growth factor (VEGF) into the formulation of Lyons" in
order "to treat posterior ocular conditions such as macular degeneration"
(Ans. 4).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that Lyons and
Chang suggest the use of therapeutic proteins and copolymers as required by
the claims?
Findings of Fact (FF)
10. Chang teaches "[i]ntraocular drug delivery systems in
accordance with the disclosure herein comprise a therapeutic component and
a drug release sustaining component associated with the therapeutic
component" (Chang,r 8).
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11. Chang teaches "[ t ]herapeutic agents according to the present
invention include peptides, polypeptides, proteins, oligonucleotides, and
nucleic acids" ( Chang ,r 10).
12. Chang teaches an embodiment where the therapeutic agent
"comprises at least a portion of a naturally occurring or synthetic antibody or
antibody mimic having the ability to inhibit human VEGF activity" (Chang
,r 3 7). Chang teaches an alternative embodiment where an siRNA may be
used to silence VEGF (see Chang ,r 40).
13. Chang teaches that "VEGF is a substance that stimulates the
growth of new blood vessels. The development of new blood vessels,
neovascularization or angiogenesis, in the eye is believed to cause loss of
vision in wet macular degeneration" (Chang ,r 78).
14. Chang teaches the "polymeric component of the present
systems may comprise a polymer selected from the group consisting of poly-
lactic acid (PLA), poly-glycolic acid (PGA), polylactide-co-glycolide
(PLGA)" (Chang,r 24).
15. Chang teaches that the "system may comprise a mixture of a
frrst biodegradable polymer and a different second biodegradable polymer"
(Chang ,r 112).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2--4; FF 1-15). We address
Appellants' arguments below.
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Claim 1
Biodegradable polymer matrix
Appellants reiterate their argument that neither of the prior art
references suggests the combination of "first poly(D,L-lactide-co-glycolide)
and a second poly(D,L-lactide-co-glycolide)" (Br. 24).
We remain unpersuaded for the reasons given above. In particular,
Chang expressly teaches the "system may comprise a mixture of a frrst
biodegradable polymer and a different second biodegradable polymer" (FF
15), as well as teaching the polymers acknowledged by Appellants as
expressly recited (see Br. 23-24). Thus, we remain persuaded that the
combination of two known polymers, as suggested by both Lyons and
Chang, would have been prima facie obvious.
Claim2
Appellants reiterate both their argument that the 90:10 ratio of PLGA
copolymers is not obvious (see Br. 24) and their argument that the
Specification demonstrates unexpected results (see Br. 25).
We remain unpersuaded for the reasons given above including that the
ratio of polymers is prima facie obvious as an optimizable variable, and that
the unexpected results are neither identified as unexpected by the
Specification or any Declaration evidence nor commensurate in scope with
the much greater breadth of the claims.
Claim 3
While Appellants do not separately argue claim 3 in this rejection, we
note that while Lyons does not teach the ocular conditions recited in claim 3,
Chang teaches the use of VEGF (FF 12) to treat conditions including
macular degeneration, a condition listed in claim 3 (FF 13 ). We therefore
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agree with the Examiner that it would have been obvious to "incorporate
antibodies that bind vascular endothelial growth factor (VEGF) into the
formulation of Lyons" in order "to treat posterior ocular conditions such as
macular degeneration" (Ans. 4).
Claim 6
Appellants contend that claim 6, much more narrowly drawn to
particular PLGAcopolymers and particular amounts ofVEGF and other
components is unobvious and is supported by unexpected results (see Br. 24,
25). While claim 6 may be sufficiently narrow to be commensurate with the
result shown in the Specification (see Spec. 34:4 to 35 :8), there is still no
statement other than attorney's argument, that these results are, in fact,
unexpected. See Geisler, 116F.3dat 1471 ("[T]heonlyreferenceto
unexpected results was a statement by [Appellant's] counsel, in response to
the examiner's frrst rejection, that [Appellant's] results were 'surprising. '
And, as the [In re] Soni[, 54 F.3d 745, 750 (1995)] court itself noted, naked
attorney argument is 'insufficient to establish unexpected results."').
Claim 14
Appellants contend that "there is nothing in Lyons in view of Chang
which teaches or suggests the step of blending the dry powder with at least
two poly(D,L-lactide-co-glycolide) copolymers to form a mixture wherein
one of the copolymers has an ester end group and the other copolymer has
an acid end group" (Br. 25).
We again fmd this argument persuasive because the Examiner
identifies no teaching from Lyons or Chang or other reason for blending a
polymer with an ester group with the copolymers as a dry powder. And
while Lyons and Chang both mention the use of an acid end group (FF 6;
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Chang ,r 109), the Examiner does not identify a teaching or evidence that
one of the cited copolymers of Lyons had an ester end group. The Examiner
has the initial burden of establishing a prima facie case obviousness under
35 U.S.C. § 103. Oetiker, 977F.2dat 1445.
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
conclusion that Lyons and Chang suggest the use of therapeutic proteins and
copolymers as required by claims 1, 2, 3, and 6.
A preponderance of the evidence of record does not support the
Examiner's conclusion that Lyons and Chang suggest the use of therapeutic
proteins and copolymers as required by claim 14.
SUMMARY
We affrrm the rejection of claims 1-2 and 7-13 under35 U.S.C.
§ 103(a) as obvious over Lyons.
We reverse the rejection of claims 3 and 14 under35 U.S.C. § 103(a)
as obvious over Lyons.
We affrrm the rejection of claims 1-13 under 35 U.S.C. § 103(a) as
obvious over Lyons and Chang.
We reverse the rejection of claim 14 under 35 U.S.C. § 103(a) as
obvious over Lyons and Chang.
Claim 14 is not subject to any pending rejection.
We designate our affrrmance as a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b ). Section4I.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered fmal for judicial review."
Section 41. 5 O(b) also provides:
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When the Board enters such a non-fmal decision, the
appellant, within two months from the date of the decision,
must exercise one of the following two options with respect to
the new ground 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. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of
rejection designated in the decision. Should the examiner reject
the claims, appellant may again appeal to the Board pursuant to
this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41. 52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Pa tent Examining Procedure § 1214.01.
AFFIRMED-IN-PART; 37 C.F.R. §4I.50(b)
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