Ex Parte 6429231 et al

Patent Trial and Appeal Board

Sep 17, 2013

95000319 (P.T.A.B. Sep. 17, 2013)

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.
95/000,319 01/07/2008 6429231 2009982-0019 2173
24280 7590 09/17/2013
CHOATE, HALL & STEWART LLP
TWO INTERNATIONAL PLACE
BOSTON, MA 02110
EXAMINER
JONES, DWAYNE C
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
09/17/2013 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
____________

RIVER’S EDGE PHARMACEUTICALS, LLC
Requester and Respondent

v.

NYCOMED US, INC.
Patent Owner and Appellant
____________

Appeal 2013-003203
Reexamination Control 95/000,319
Patent 6,429,231 B1
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Patent Owner in the above-identified
inter partes reexamination of US 6,429,231 B1. Patent Owner appeals the
Examiner’s decision to reject claims 1, 3, and 4 as obvious under 35 U.S.C. § 103
over prior art. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b),
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134, and 315. We reverse, but set forth a new ground of rejection under 37 C.F.R.
§ 41.77(b).
I. STATEMENT OF THE CASE
The patent in dispute in this appeal is US 6,429,231 B1 (“the ‘231 patent),
which issued August 6, 2002. A corrected request for inter partes reexamination
of the ‘231 patent was filed on January 7, 2008 by a Third Party Requester under
35 U.S.C. §§ 311-318 (2002) and 37 C.F.R. §§ 1.902-1.997 (Request for Inter
Partes Reexamination). The Patent Owner is Nycomed US Inc. (Appeal Br. 1,
dated January 3, 2011). The Third Party Requester did not file a brief or comments
in response to the Examiner Answer or Patent Owner’s Appeal Brief.
The claims of the ‘231 patent are directed to a topical composition
consisting essentially of sodium sulfacetamide, sulfur, and urea, and a method
administering the composition to a subject to treat acne or rosacea. Claims 1, 3,
and 4 are pending. Claims 2, 5, and 6 have been canceled. Claim 1 is an
independent claim, and claims 3 and 4 depend on it.

II. REPRESENTATIVE CLAIM
Representative claim 1 is reproduced below (underlining and bracketing
indicate amendments relative to the original claim):
1. (Amended) A topical composition for treatment of [dermatological
disorders] acne or rosacea consisting essentially of:
(a) a [dermatologically] bactericidally effective amount of a
combination of about 5-20% by weight sodium sulfacetamide
[or a salt thereof] and about 1 to about 10% by weight sulfur;
(b) about 10 to about 40% by weight of urea; and
[(c) sulfur; and]
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(d) a dermatologically acceptable carrier, wherein said (a) and (b)
provide an effective treatment for acne and rosacea upon topical
application of said composition to skin in need thereof.

III. REJECTIONS
Claims 1, 3, and 4 stand rejected by the Examiner as follows:
1. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Sun
(PCT WO 96/19186) in view of Shacknai (US 6,514,489).
2. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Vincent
(US 2,460,776) in view of Shacknai.
3. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Sun in view
of Shacknai and further in view of Stiefel (US 7, 022,332).
4. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Sun in view
of Shacknai and further in view of Thiboutot (Thiboutot, Diane, MD, New
Treatments and Therapeutic Strategies for Acne, 9 Arch. Fam. Med. 179 (2000)).
5. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Vincent in
view of Shacknai, and further in view of Stiefel.
6. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Vincent in
view of Shacknai, and further in view of Sun.
7. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Vincent in
view of Shacknai, and further in view of Thiboutot.
8. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Sun in view
of Shacknai, and further in view of Ferrari (US 3,860,712).
9. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Sun in view
of Shacknai and further in view of Vincent.
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10. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Sun in view
of Shacknai, and further in view of Waldstreicher (US 5,543,417).
11. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Vincent in
view of Shacknai, and further in view of Ferrari.
12. Claims 1, 3 and 4 under 35 U.S.C. § 103(a) as obvious over Vincent in
view of Shacknai, and further in view of Waldstreicher.

IV. REJECTIONS BASED ON VINCENT
Grounds 2, 5-7, 11, and 12 are all based on Vincent combined with different
secondary publications, where each of the secondary publications is cited for
substantially the same teachings. We shall therefore address these rejections as a
group.
The Examiner found that Vincent describes a composition with urea as in
claim 1. See, e.g., Right of Appeal Noticed, dated October 1, 2010 (“RAN”) 18-
19. Vincent contains the following teachings, which we enumerate as findings of
fact:
V1. Vincent describes “a new fluid base composition, a new fused bentonite
sulfur composition, and other compositions made with said fluid base
composition.” (Col. 1, ll. 2-5.)
V2. The fluid base composition “is a valuable synergistic, medicinal, and
cosmetic vehicle which combines the properties of a carrier and of a wetting and
penetrating agent, in addition to a bacteriostatic action.” (Col. 1, ll. 9-12.)
V3. “The new fused bentonite sulfur compositions made by compounding
fused bentonite sulfur with the fluid base, form valuable medicaments for the
treatment of various skin diseases and infections . . .” (Col. 1, ll. 30-34.)
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V4. Fused bentonite “is made by fusing together Wyoming bentonite with
sulfur and grinding the resulting product to a fine state of subdivision.” (Col. 1,
ll. 39-42.)
V5. “The fused bentonite sulfur, when compounded with the fluid base,
gives compositions having active bacteriostatic, bactericidal and fungicidal
properties.” (Col. 1, ll. 42-45.)
V6. The fluid composition comprises urea, sodium taurocholate, quince
seed extract, glycerin, alcohol, water, oil of rose (optional), and coloring agent
(optional) (col. 2, ll. 33-42).
V7. “In the fluid base composition the alcohol and urea appear to act
synergistically in imparting bacteriostatic and bactericidal action to the
composition.” (Col. 3, ll. 59-62.)
V8. “The commercial sodium taurocholate not only acts as a wetting agent
but it contains an active factor or ingredient, which acting synergistically with the
other components of the fluid base, produces bacteriostatic action.” (Col. 3, ll. 66-
71.)
V9. The active principle in the sodium taurocholate is also present in ox
bile, and sodium taurocholate can be substituted in whole or part by ox bile (col. 4,
ll. 5-7 & 54-57).
V10. “The fused bentonite sulfur emulsion also appears to have a general
emollient and healing action on the skin, probably due to a synergistic action
between the fluid base and the fused bentonite sulfur, since neither product acting
alone is as effective.” (Col. 6, ll. 15-20.)
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V11. “The new fused bentonite sulfur emulsions and creams have been
found effective in treating various skin infections. Clinical use of the composition
has shown it to be effective in the treatment of . . . acne . . .” (Col. 8, ll. 68-74.)
The Examiner found that Vincent teaches a composition with sulfur and
urea as claimed, but not with sodium sulfacetamide (RAN 18-19). However, the
Examiner found that Shacknai describes sodium sulfacetamide and sulfur as anti-
microbial agents that are useful in dermatological compositions (id). The
following teachings from Shacknai are pertinent:
Sh1. Shacknai teaches that elemental sulfur in a variety of forms is useful
for the treatment of various dermatological conditions, including rosacea, as a
result of its anti-microbial and anti-fungal activity (col. 1, ll. 14-26).
Sh2. Shacknai teaches various suitable sulfur ingredients including sodium
sulfacetamide (col. 2, ll. 50-54) and elemental sulfur (col. 2, ll. 60-65).
Sh3. Shacknai describes an example of such a composition with sodium
sulfacetamide and sodium thiosulfate (col. 6, Example 1).
The Examiner also found that Stiefel describes dermatological compositions
with sodium sulfacetamide and sulfur (RAN 25). The following findings from
Stiefel are pertinent:
St1. Stiefel teaches that “[s]odium sulfacetamide with and without sulfur
has been utilized for many years to treat acne.” (Col. 1, ll. 32-33.)
St2. Stiefel teaches “a sulfacetamide and a sunscreen in combination for the
treatment of rosacea.” (Col. 2, ll. 42-43.)
St3. Stiefel also teaches a composition with sulfacetamide, precipitated
sulfur (col. 4, ll. 18-19), and a sunscreen avobenzone (col. 3, ll. 10 & 26).
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St4. Stiefel teaches that “[m]issing in the art is a convenient means to ensure
patient compliance with topical administration of a sulfacetamide and a
sunscreen.” (Col. 2, ll. 13-15.) The amount of the sunscreen employed is
sufficient to block some measurable quantity of UV radiation (col. 3, ll. 29-34).
The Examiner found that that it would have been obvious to one having
ordinary skill in the art to include sulfacetamide and sulfur as taught by Shaknai
and Stiefel in the topical, anti-bacterial composition of Vincent “in order to arrive
at the claimed invention with a reasonable expectation of obtaining a more
effective topical composition for treating dermatological disorders, namely acne
and rosacea.” (RAN 19 & 26.) Similar facts and reasoning were set forth in the
rejections based on Thiboutot (RAN 42-43) and Waldstreicher (RAN 66-67).
Patent Owner contends that “even assuming some motivation to combine
Vincent” with Shacknai and Stiefel, the resulting combination would include the
sodium taurocholate of Vincent, which is excluded from claim 1 by the phrase
“consisting essentially of” because the latter affects the basic and novel properties
of the invention (Appeal Br. 7-8 and 9).
The issues in these rejections (Grounds 2, 5-7, 11, and 12) are as follows:
1) Whether “consisting essentially of” as recited in claim 1 excludes sodium
taurocholate as described in Vincent;
2) If sodium taurocholate is excluded, did the Examiner establish by the
preponderance of the evidence that it would have been obvious to have to have
utilized urea only as taught by Vincent or Ferrari combined with sodium
taurocholate as described in Shacknai, Stiefel, Thiboutot, or Waldstreicher.

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Discussion
We first begin with claim interpretation, particularly the proper
interpretation of “consisting essentially of.” Claim 1 is directed to a “topical
composition” that is “consisting essentially of” sodium sulfacetamide, sulfur, and
urea. The term “consisting of” would be read to exclude any other ingredient.
However, “consisting essentially of” is less rigid. The phrase “‘consisting
essentially of’” in a patent claim “has long been understood to permit inclusion of
components not listed in a claim, provided that they do not ‘materially affect the
basic and novel properties of the invention.’” AK Steel Corp. v. Sollac and Ugine,
344 F.3d 1234, 1239 (Fed. Cir. 2003) (citations omitted). The question therefore is
what ingredients are specifically excluded from the claims and which are included
by the recitation of “consisting essentially of.” To answer this question, it is
necessary to consult the written description of the ‘231 patent to identify the “basic
and novel” properties of the claimed invention.
The ‘231 patent teaches that “compositions comprising dermatologically
effective amounts of a combination of antimicrobial agents and urea are not
currently available.” (‘231 patent, col.1, ll. 55-58.) The patent teaches that the
“present invention relates to a topical composition that combines the benefits of
urea and antimicrobial agents.” (Id. at col. 1, ll. 26-27.) Urea is said to have
various activities, including antimicrobial activity (id. at col. 6, ll. 1-4). Both
sulfur and sulfacetamide are known antimicrobial agents (Sh1 and Sh2). The
compositions are said to be “useful in treating dermatological disorders.” (Id. at
col 1, ll. 36-37.) Based on this disclosure, the skilled worker, reading the ‘231
patent, would understand that the invention’s basic and novel property is the
antimicrobial activity of the composition. For this reason, any ingredient that
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affects the composition’s antimicrobial activity is excluded from the composition,
including an additional antimicrobial agent or one that inhibits the activity.
Vincent’s composition contains sodium taurocholate, which is said by
Vincent to contain an active factor that produces bacteriostatic action, namely, it
possesses antimicrobial activity (V8). Consequently, we agree with Patent Owner
that sodium taurocholate is excluded from the claimed composition by the phrase
“consisting essentially of.” Thus, combining Vincent’s composition comprising
sodium taurocholate with the sodium sulfacetamide described in Shacknai, Stiefel,
Thiboutot, or Waldstreicher would result in a composition outside the scope of
claim 1.
The Examiner incorrectly found that “Vincent's sodium taurocholate is
regarded as an adjuvant or additive to its composition” (RAN 23), ignoring the
explicit teaching in Vincent that the latter compound “produces bacteriostatic
action” (V8). Thus, the Examiner did not appreciate or acknowledge the full scope
of what is taught by Vincent.
The next issue is whether it would have been obvious to one of ordinary skill
in the art to use the urea and sulfur in Vincent in combination with the sodium
sulfacetamide described in Shacknai, Stiefel, Thiboutot, or Waldstreicher cited for
the same teachings. In other words, would it have been obvious to exclude sodium
taurocholate from Vincent’s composition?
Vincent specifically teaches that sodium taurocholate acts synergistically
with the other components of the fluid base to produce an antimicrobial action
(V8). Synergy is also described as a property of the composition as a whole (V2),
the alcohol component (V7), urea (V7), and the bentonite sulfur (V10). In view of
this explicit teaching of synergy for each component of Vincent, Vincent does not
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provide a reason to the skilled worker to separate the various components from
each other and use each individually, or omit one or more from the composition.
For example, the urea, itself, is said “to act synergistically in imparting
bacteriostatic and bactericidal action to the composition.” (V7.) There is
insufficient evidence based solely on Vincent that the skilled worker would have
reason to use the urea, alone, when urea’s advantageous and synergistic properties
are achieved with the other components in the fluid base (V7). It also would not
have been obvious to just omit sodium taurocholate from Vincent’s composition
when sodium taurocholate is described as acting synergistically with the other
components (V8).
The Examiner did not provide adequate reason to have picked just urea from
Vincent, and omitted sodium taurocholate, since Vincent teaches that the
components in its composition act synergistically together to produce antimicrobial
activity. Based on Vincent’s teachings, the skilled worker would not have been
prompted to use urea apart from sodium taurocholate and the other components in
Vincent’s composition. Accordingly, we reverse rejections 2, 5-7, 11, and 12.

V. NEW GROUND OF REJECTION BASED ON FERRARI
Ferrari is cited in Rejection 11. Patent Owner states that Ferrari is an
“allege[d]” improvement over Vincent “by substituting an ‘unconjugated bile acid’
such as deoxycholic acid for the taurocholate taught to be essential by
Vincent et al.” (Appeal Br. 10). Ferrari teaches a combination of urea and
unconjugated bile acid in an alcohol base (Ferrari, Abstract). Bile salt is described
by Vincent as having the same active principle in sodium taurocholate that
produces the antimicrobial activity (V8 & V9). Thus, as an agent with
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antimicrobial activity, bile is excluded from claim 1 by the phrase “consisting
essentially of.”
Ferrari teaches, as Vincent similarly teaches, that the combination of urea
and the bile acid is “surprisingly effective” (Ferrari, col. 1, ll. 46-47; emphasis
added.)
Ferrari also contains the following additional pertinent teachings, which we
enumerate as factual findings:
Fe1. Ferrari teaches a combination of urea and unconjugated bile acid in an
alcohol base (Ferrari, Abstract).
Fe2. Ferrari also teaches that its composition is for treating of acne or
seborrhea (Ferrari, col. 1, ll. 4-5).
Fe3. “The use of urea in hastening the healing of wounds and the treatment
of certain skin conditions, such as ichthyosis and other hyperkeratotic skin
diseases, is known.” (Ferrari, col. 1, ll. 38-41.)
In other words, Ferrari contains a teaching that urea alone (e.g., not in
combination with unconjugated bile acid) has been used to treat skin conditions
(Fe3). This latter most teaching was missing from Vincent, since Vincent
describes urea only in synergistic combination with other skin ingredients,
including sodium taurocholate. Ferrari, however, contains broader disclosure
about the use of urea to treat skin conditions.
Since Ferrari describes compositions to treat acne (Fe2), and the
compositions contain urea, one of ordinary skill in the art would have had reason to
use urea in combination with other agents known to treat acne, namely, sodium
sulfacetamide and sulfur, as taught in Shacknai (Sh1-Sh3) and Stiefel (St1), to
have made the subject matter of claims 1, 3, and 4. Furthermore, since Ferrari
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describes urea compositions to treat skin conditions that do not also contain
unconjugated bile acid (Fe3), one of ordinary skill in the art would have reason to
omit unconjugated bile acid and sodium taurocholate from such compositions. It is
routine to formulate skin treatment compositions with one or more active agents to
produce an effective composition for treating various skin conditions (Sh1, Sh3,
St1, and St2).
Since our rationale differs from the Examiner’s, and we rely on a different
combination of prior art publications, we designate it as a new ground of rejection
under 37 C.F.R. § 41.77(b). The rejection is as follows:
Claims 1, 3 and 4 are rejected under 35 US.C. § 103(a) as obvious over
Ferrari, Shacknai, and Stiefel.

VI. REJECTIONS BASED ON SUN
Rejections 1, 3, 4, and 8-10 are all based on Sun combined with different
publications, each of the latter being cited for substantially the same teachings. We
shall therefore address these rejections as a group.
The Examiner found that Sun teaches “a method for the topical treatment of
fungal diseases in nails and the surrounding skin by topical administration of a
composition containing” urea and an antifungal agent (RAN 13). The Examiner
acknowledged that Sun does not describe sulfacetamide and sulfur “as anti-fungal
agents” (id.). To meet this deficiency, the Examiner cited Shaknai (id. at 12),
Stiefel (id. at 25), Thiboutot (id. at 31-32), and Waldstreicher (id. at 57). Based on
these teachings, the Examiner concluded that it would have been obvious to one
having ordinary skill in the art to include “the anti-microbial (anti-bacterial) agents
of sulfacetamide and sulfur as taught” by Shaknai, Stiefel, Thiboutot, and
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Waldstreicher “in the topical composition of Sun et al. in order to arrive at the
claimed invention with a reasonable expectation of obtaining a more effective
topical composition for treating dermatological (fungal) disorders.” (Id. at 13.)
We shall reverse these rejections. All the publications relied upon by the
Examiner for teaching sulfacetamide and sulfur are for the application to the skin,
particularly to treat bacteria and skin disease (Sh1; St1; St2; Thiboutot, Abstract
and pp. 184-185; Waldstreicher, Abstract). Sun, on the other hand, describes
treating fungal disease in nails (Abstract). The Examiner did not provide a
sufficient rationale for why a skilled worker would have been prompted to
incorporate agents for treating skin into a composition for treating nails. Instead,
the Examiner erroneously found that Sun treats skin surrounding the nail, implying
that Sun also treats skin conditions.
Sun teaches:
This invention provides a delivery means for topical treatment of
fungal diseases of the nail which delivers an effective dose of drug to
(a) the diseased nail plate (and consequently, the underlying nail bed),
of which the hydration capability has been significantly increased to
enhance drug permeability (nail route); and (b) the surrounding skin
tissues, including nail bed and matrix via the eponychium and
hyponychium (skin route - see Figure 1).
(Sun, p. 3, ll. 2-9; emphasis added)
Figure 1 of Sun is reproduced below:

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Figure 1 shows the following features as described below:
The term “nail” means the horny cutaneous plate on the dorsal surface
of the distal end of a finger or toe. Fig. 1 is a schematic diagram
showing the basic anatomic structure of human nail and its
surrounding tissues. The topical antifungal drug treatment for nail
fungal disease (onychomycosis) contemplated by this invention is
intended to deliver antifungal drug to the nail plate (the stratum
corneum unguis) and to the nail bed (the modified area of epidermis
beneath the nail, over which the nail plate slides as it grows) through
the nail plate. Desirably, antifungal drug is also concurrently
administered to the nail matrix (the proximal portion of the nail bed
from which growth chiefly proceeds) and nail bed through the skin of
the eponychium (commonly called the cuticle) and the
hyponychium (the thickened epidermis underneath the free distal
end of the nail).
(Sun, p.7, ll. 5-20; emphasis added)
As indicated above, the “surrounding skin tissues” referred to by the
Examiner appear to be the eponychium (cuticle) and the hyponychium (“thickened
epidermis” underneath the distal end of the nail), which are modified epidermis.
The Examiner did not provide adequate evidence that these specialized regions of
the nail are equivalent to the skin regions of Shaknai, Stiefel, Thiboutot, and
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Waldstreicher and susceptible to the same skin disorders described in these
publications. For this reason, we do not agree that the evidence supports the
Examiner’s conclusion that one of ordinary skill in the art would been prompted to
put sulfacetamide and sulfur, agents that are used to treat skin disorders, into Sun’s
composition taught for nails.
Furthermore, the mechanism described in Sun for urea’s activity is specific
for the nail:
Urea is employed in the invention. It is believed that urea’s principal
contribution to the efficacy of the formulation used in the invention is
to inhibit the nail keratin from returning to its original densely packed
cross-linked state (such return to the original densely packed cross-
linked state would be caused by oxidation from the oxygen in the
atmosphere), so that the nail remains more permeable to the antifungal
drug over a longer period of time. (The ability of urea to inhibit the
nail keratin from returning to its original densely packed cross-linked
state probably stems from urea's ability to disrupt non-covalent
interactions in nail keratin.)
(Sun, p. 8, ll. 16-26.)
Sulfhydryl-containing amino acids are utilized in Sun, but these are used to
break the keratin bonds in the nails (Sun, p. 2, ll. 24-26) and enhance permeation of
anti-fungal drugs (id. at p. 10, ll. 41-43). In fact, Sun teaches a device that
“prevent[s] the sensitive eponychium skin from direct contact with the sulfhydryl
penetration enhancer” (id. at p. 26, ll. 3-4), teaching away from the direct
application of sulfur containing compounds to the nail.
In sum, the composition described by Sun operates in an entirely different
way than the skin compositions of Shaknai, Stiefel, Thiboutot, and Waldstreicher.
Given these material differences, the Examiner did not provide a sufficient

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rationale for why one of ordinary skill in the art would have been prompted to
combine Sun with Shaknai, Stiefel, Thiboutot, and Waldstreicher.
For the foregoing reasons, Rejections 1, 3, 4, and 8-10 are reversed.

TIME PERIOD; NEW GROUND OF REJECTION
This decision contains a new ground of rejection pursuant to 37 C.F.R.
§ 41.77(b) which provides that “[a]ny decision which includes a new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Accordingly, no portion of the decision is final for purposes of judicial
review. A requester may also request rehearing under 37 C.F.R. § 41.79, if
appropriate, however, the Board may elect to defer issuing any decision on such
request for rehearing until such time that a final decision on appeal has been issued
by the Board.
For further guidance on new grounds of rejection, see 37 C.F.R. § 41.77(b)-
(g). The decision may become final after it has returned to the Board. 37 C.F.R.
§ 41.77(f).
37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN ONE
MONTH 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. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response must be either an
amendment of the claims so rejected or new evidence relating to the claims so
rejected, or both.
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(2) Request rehearing. The owner may request that the proceeding be
reheard under § 41.79 by the Board upon the same record.
Any request to reopen prosecution before the examiner under 37 C.F.R.
§ 41.77(b)(1) shall be limited in scope to the “claims so rejected.” Accordingly, a
request to reopen prosecution is limited to issues raised by the new ground(s) of
rejection entered by the Board. A request to reopen prosecution that includes
issues other than those raised by the new ground(s) is unlikely to be granted.
A requester may file comments in reply to a patent owner response.
37 C.F.R. § 41.77(c).
Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for all
patent owner responses and requester comments, is required.
The examiner, after the Board’s entry of a patent owner response and requester
comments, will issue a determination under 37 C.F.R. § 41.77(d) as to whether the
Board’s rejection is maintained or has been overcome. The proceeding will then
be returned to the Board together with any comments and reply submitted by the
owner and/or requester under 37 C.F.R. § 41.77(e) for reconsideration and issuance
of a new decision by the Board as provided by 37 C.F.R. § 41.77(f).

REVERSED; § 41.77(b)

ak

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Choate, Hall & Stewart, LLP
Two International Place
Boston, MA 02110

Third Party Requester:

Steven Hultiquist
P.O. Box 14329
Research Triangle Park, NC 27709