Ex Parte Rudolph et al

Patent Trial and Appeal Board

Feb 26, 2018

11597514 (P.T.A.B. Feb. 26, 2018)

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.
11/597,514 11/27/2006 Markus Rudolph MERCK-3253 5580
23599 7590 02/28/2018
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
DAVIS, RUTH A
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
02/28/2018 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARKUS RUDOLPH, STEFAN HENKE, and IRIS MANNECK
Appeal 2017-000647
Application 11/597,514
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to an oral administration form comprising a
pharmaceutically acceptable carrier and at least one species of a probiotic
microorganism. Claims 1—26 are on appeal as rejected under 35 U.S.C.
§ 103. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part and enter a new ground of rejection for claim 26
under 35 U.S.C. § 103(a), pursuant to our authority under 37 C.F.R.
§ 41.50(b).
1 Appellants identify the Real Party in Interest as “Merck Patent GmbH.”
App. Br. 1 (we consider and reference herein the Amended Appeal Brief
submitted May 10, 2016).
Appeal 2017-000647
Application 11/597,514
STATEMENT OF THE CASE
Claims 1, 22, 23, and 26 are the independent claims; they are
representative and are reproduced below:
1. An oral administration form comprising a
pharmaceutically acceptable carrier and at least one species of a
probiotic microorganism, wherein the oral administration form
and/or the probiotic microorganism is/are provided with a
coating comprising at least two cellulose ethers which contain
hydroxyalkyl groups as substituents
wherein said oral administration form does not contain a
gastric juice resistant coating and does not contain a softener.
22. An oral administration form comprising a
pharmaceutically acceptable carrier and at least one species of a
probiotic microorganism that is Lactobacilli, Bifidobacteria or
Streptococci,
wherein the oral administration form and/or the probiotic
microorganism is/are provided with a coating comprising
hydroxypropylmethylcellulose, hydroxypropylcellulose and a
stearate and said coating has a thickness of 5 to 15mg per cm2.
23. An oral administration form comprising a
pharmaceutically acceptable carrier and at least one species of a
probiotic microorganism, wherein the oral administration form
and/or the probiotic microorganism is/are provided with a
coating comprising hydroxypropylmethylcellulose and
hydroxypropylcellulose and
wherein the survival rate of said probiotic microorganisms
in the small intestine is at least 5-fold compared with the
uncoated administration form.
26. An oral administration form comprising a
pharmaceutically acceptable carrier and at least one species of a
probiotic microorganism, wherein the oral administration form
and/or the probiotic microorganism is/are provided with a
coating comprising hydroxypropylmethylcellulose and the
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hydroxypropylcellulose in a weight ratio to one another of 90:10
to 10:90
wherein said oral administration form does not contain a
gastric juice resistant coating and does not contain a PEG
softener.
App. Br. 13, 15—16 (Claims App’x).
The following rejections are on appeal:
Claims 1—10, 12—19, 21, and 23—26 stand rejected under 35 U.S.C.
§ 103(a) over Giampapa2 and Bechtold-Peters.3 Final Action 3.
Claims 1—25 stand rejected under 35 U.S.C. § 103(a) over Giampapa,
Bechtold-Peters, and Robinson.4 Id. at 5.
FINDINGS OF FACT
FF1. The Specification states, “[t]he object of the present
invention was to provide an oral administration form which liberates
the probiotic microorganisms reproducibly in the human and/or
animal intestine in order to ensure the activity of the probiotic
microorganisms.” Spec. 2.
FF2. The Specification states, “[t]he mixing ratios of the
cellulose ethers [HPMC and HPC] to one another which are necessary
in each case for the desired release profile and the layer thickness
which is necessary in each case can be determined and optimised here
with reference to experiments in in-vitro models.” Spec. 4.
FF3. Appellants state, “the present invention provides an oral
administration form which reproducibly liberates probiotic
2 US 2004/0001817 A1 (pub. Jan. 1, 2004) (“Giampapa”).
3 US 2002/0160048 A1 (pub. Oct. 31, 2002) (“Bechtold-Peters”).
4 US 2002/0160046 A1 (pub. Oct. 31, 2002) (“Robinson”).
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Application 11/597,514
microorganisms in the small intestine and ensures the activity of the
probiotic microorganisms without the disadvantages of an enteric
coating or a softener.” App. Br. 4. Further, Appellants state,
the present invention releases probiotic organisms. Rapid release
of probiotic organisms would result in release in the stomach
after oral intake, which would lead to loss of activity of the
probiotic microorganisms due to their destruction in acid gastric
juice. The aim of the present invention is to avoid destruction of
the probiotic microorganisms in gastric juice.
Id. at 5. Moreover, Appellants state, “[rjelease [of probiotic
microorganisms] in the intestine ensures the probiotic viability,
activity and health-promoting benefits.” Id.
FF4. Robinson discloses:
a time-release dosage form for delivering an acid-labile
pharmaceutical, such as omeprazole, into the upper portion of the
gastrointestinal tract downstream of the stomach. The dosage
form includes a drug-containing core surrounded by an inert
time-release coating that delays release of the drug from the core
until expiration of a certain time period after administration,
generally 0.5-5.0 hours or 1-3 hours. When the gastrointestinal
fluid contacts the core, the drug is released rapidly into the GI
tract. The dosage form does not contain an enteric coating.
Robinson Abstract; see also Final Action 5, 7 and Answer 5, 7, 9, 11—
13 (discussing Robinson).
FF5. Robinson discloses, “[t]he core of the solid dosage form
is a substrate such as a . . . tablet core,” which “is formulated into an
immediate-release formulation,” and which “is surrounded by a time-
release coating.” Robinson || 27, 31—32; see also Final Action 5, 7
and Answer 5, 7, 9, 11—13 (discussing Robinson).
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FF6. Robinson discloses “[a] solid dosage form that provides a
delayed and subsequently rapid release” that comprises “a core” and
“a time-release non-enteric water soluble or water erodible coating
surrounding and in contact with the core,” where “the time-release
coating comprises one or more components selected from the group
consisting of HPMC, HPC, PVP, ethylcellulose, non-enteric acrylic
polymer, protein, talc, clay, kaolin, glycerin monostearate, wax,
silicon dioxide, polysaccharide, polyethylene oxide, and alkaline
buffering agent.” Robinson claims 1,21 (emphasis added); see also
Final Action 5, 7 and Answer 5, 7, 9, 11—13 (discussing Robinson).
FF7. Robinson discloses:
The time-release coating will generally comprise film-
forming compounds such as cellulosic derivatives, such as
hydroxypropylcellulose [HPC], methylcellulose, hydroxypropyl
m ethylcellulose [HPMC], hydroxy ethylcellulose, and/or acrylic
polymers including the non-enteric forms of the Eudragit™
brand polymers. Other film-forming materials may be used
alone or in combination with each other or with the ones listed
above. These other film forming materials generally include
poly(vinylpyrrolidone), Zein, polyethylene glycol) [PEG],
polyethylene oxide), poly(vinyl alcohol), poly(vinyl acetate),
and ethyl cellulose, as well as other pharmaceutically acceptable
hydrophilic and hydrophobic film-forming materials.
Robinson 133 (emphasis added); see also Final Action 5, 7 and
Answer 5, 7, 9, 11—13 (discussing Robinson).
FF8. Robinson discloses that “[sjuitable binders,” such as
“poly-ethylene glycol,” “can be added to the formulation.” Robinson
1 53 (emphasis added); see also Final Action 5, 7 and Answer 5, 7, 9,
11—13 (discussing Robinson).
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FF9. Robinson teaches that its disclosed time-release coating
is necessary because the disclosed drug, omeprazole, degrades very
rapidly in acidic aqueous solutions, such as found in the stomach, and
teaches that while an enteric coating could protect the drug for release
downstream from the stomach, there are disadvantages to enteric
coatings making an alternative desirable. Robinson || 2—7; see also
Final Action 5, 7 and Answer 5, 7, 9, 11—13 (discussing Robinson).
FF10. Robinson discloses:
[t]he pH of the film coating during application onto the core is
generally maintained in the neutral to alkaline range, or in the pH
range of about 8-10. This pH range may be achieved by the
incorporation of suitable buffering agents or inherently alkaline
additives, such as ... magnesium stearate . . ., into the
composition from which the time-release coating is made.
Robinson | 50; see also Final Action 5, 7 and Answer 5, 7, 9, 11—13
(discussing Robinson). Robinson also discloses stearates, such as
magnesium stearate, can be included in the composition as an anti­
adherent or lubricant. Robinson || 59, 63; see also Final Action 5, 7
and Answer 5, 7, 9, 11—13 (discussing Robinson).
FF11. Robinson discloses:
The quantity of time-release coating needed for each
formulation will depend upon the surface area of the core, or the
particle size of the pellets/granules, in order to control the lag
time for drug released from the core.
The thickness of the time-release coating will control the
time required for an aqueous solution to penetrate or erode the
coating and reach the core. The influence of film thickness on
the lag time for the core tablet to disintegrate and release drug is
depicted in FIG. 3. As additional coatings of the same
composition are applied to tablet cores, the thickness of the time-
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release coating increases, and the time (lag time) to disintegrate
the tablet and to release the drug into solution increases, as shown
by Profiles “A-C”. Generally, the time-release coating will be
about 100-5000 microns, or about 250-1000 microns, or at least
about 200 microns thick, depending upon the material(s) from
which it is made.
Robinson || 45 46; see also Final Action 5, 7 and Answer 5, 7, 9,
11—13 (discussing Robinson).
FF12. Robinson discloses, “the time-release coating is about
100-5000, or 250-1000 at least about 100, microns thick and delays
the release of omeprazole from the core at least about 1 hour after
administration; 11) the time-release coating delays the release of
omeprazole from the core 1-3 hours after administration.” Robinson
115; see also Final Action 5, 7 and Answer 5, 7, 9, 11—13 (discussing
Robinson).
FF13. Robinson discloses “an exemplary relationship between
the thickness of the time-release coating on the release of omeprazole
from a time-release pellet or tablet. As the thickness of the coating
layer increases from A to C, the lag time, i.e., the delay in the period
of time it takes to begin releasing omeprazole from the core,
increases.” Robinson 123; see also Final Action 5, 7 and Answer 5,
7, 9, 11—13 (discussing Robinson).
FF14. Robinson discloses examples with varying amounts
(% by wt.) of cellulose ethers, e.g., HPMC at 37%, 5%, and 2%, and
without an enteric/gastric juice resistant component or identified
softener component. Robinson || 80—96; see also Final Action 5, 7
and Answer 5, 7, 9, 11—13 (discussing Robinson).
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FF15. Giampapa discloses a nutritional supplement tablet for
oral administration that, among many other things, includes probiotic
microorganisms, such as “Lactobacillus acidophilus, Lactobacillus
plantarum, Bifidobacterium bifidum and Lactobacillus caseifl to
“markedly decrease the inflammatory processes that occur at the
cellular level.” Giampapa Abstract, H 48-49, 61, 117—18, 174—75,
227—28, 419-20, claims 1, 29—34; see also Final Action 3—7 and
Answer 2—13 (discussing Giampapa).
FF16. Further to the preceding finding of fact, Giampapa
discloses a range of doses of probiotic microorganisms from 6.5 x 107
CFU to 1 x 108 CFU in formulations for administering up to three
times per day and also at higher concentrations for once-a-day
formulations, e.g., at 175 mg. Giampapa H 117—18, 174—75, 227—28,
233, 419-20; see also Final Action 3—7 and Answer 2—13 (discussing
Giampapa).
FF 17. Giampapa discloses that the aforementioned probiotic
microorganism complexes are compatible with and provided with
magnesium stearate and a “film coat (hydroxypropyl methylcellulose
[HPMC], hydroxypropyl cellulose [HPC] and polyethylene glycol
[PEG]).” Giampapa 121, 178, 231, 310, 364, 423; see also Final
Action 3—7 and Answer 2—13 (discussing Giampapa).
DISCUSSION
In analyzing obviousness “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). “[I]f a technique [or component] has been used to improve one
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device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill.” Id. at 417.
“There must be some reason, suggestion, or motivation found in the
prior art whereby a person of ordinary skill in the field of the invention
would make the combination. That knowledge can not come from the
applicant’s invention itself.” In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir.
1992). “[Interrelated teachings of multiple patents; the effects of demands
known to the design community or present in the marketplace; and the
background knowledge possessed by a person having ordinary skill in the
art, all [should be considered] in order to determine whether there was an
apparent reason to combine the known elements in the fashion claimed.”
KSR, 550 U.S. at 418.
Obviousness over Giampapa and Bechtold-Peters
The Examiner determined claims 1, 23, and 26 would have been
obvious over Giampapa and Bechtold-Peters, combined, finding Giampapa
essentially taught all the components of the oral pharmaceutical form
claimed, but for the survival result of claim 23 and the specific HPMC:HPC
ratio range of claim 26, and the exclusion of a PEG softener of claims 1 and
26. Final Action 3^4. The Examiner determined the survival result of claim
23 was an inherent, newly discovered property of a coating as disclosed by
Giampapa and that the component ratio range of claim 26 was the result of
obvious optimization of the coating components. Id. As for a coating with
HPMC and HPC, but without an enteric component and a softener, such as
PEG, the Examiner looked to Bechtold-Peters as disclosing the HPMC and
HPC components and optional inclusion or exclusion of PEG in a tablet
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coating, which, the Examiner determined, evidenced that “HPMC and HPC
were routinely used alone and known to be effective film forming agents
without PEG softeners.” Id. at 4 (citing Bechtold-Peters 117 and claims).
Appellants argue Giampapa discloses coatings that contain HPMC,
HPC, and PEG, in every case together, and that PEG is a well-known
softener used in tablet formulations (a point not contested by the Examiner);
therefore, Giampapa does not teach a coating without a softener. App. Br. 4.
Appellants argue the coatings of Giampapa are not identical to the claimed
coatings for this reason, therefore, the Giampapa coatings cannot be
considered to inherently have the same properties of the claimed coating. Id.
Appellants argue the skilled artisan would not have looked to Bechtold-
Peters to teach a coating for a probiotic formulation because one of ordinary
skill would know it would not be prudent to rapidly release a probiotic
ingredient, unlike the small molecule active of the reference (a point not
contested by the Examiner). Id. at 5. Appellants argue Bechtold-Peters
discloses that plasticizers, such as PEG, may be included in its coatings, as
shown in its examples. Id. at 6—7. Appellants argue claim 26 claims a
coating of two cellulose ethers in a ratio of 90:10 to 10:90, which is not
taught by Giampapa or Bechtold-Peters. Id. at 7—8. Appellants note that
claim 26 is not also rejected over Giampapa, Bechtold-Peters, and Robinson.
Id. at 8. Appellants argue claim 23 claims a survival rate of probiotic
microorganisms in the small intestine is at least 5-fold better with the
coating than without it, which is not taught or suggested by the Giampapa
and Bechtold-Peters references, and would not be inherent to Giampapa’s
coating, which is not identical to the claimed invention’s. Id. at 4, 8—9.
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We are persuaded that Giampapa’s disclosure of a probiotic­
comprising formulation would not be combined with a coating designed for
rapid release in the stomach upon oral administration, as is the coating in
Bechtold-Peters. See Bechtold-Peters 14. Combining references can be
based on common sense as long as the reasoning is explained sufficiently.
See Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328—29 (Fed.
Cir. 2009). However, the opposite is also true: not combining references
can also be based on common sense. Appellants state throughout their
Specification and in their briefing that it was well known that the conditions
in the stomach harm probiotic microorganisms and oral therapeutic
administration of probiotic microorganisms relies upon protecting the
microorganisms until they have passed the stomach and reach the small
intestine, which ensures their survival. FF1, FF3. It would be common
sense and scientifically logical to formulate a probiotic composition in such
a way that it is not destroyed in the stomach upon ingestion. Therefore, we
are persuaded that the Examiner did not provide sufficient evidence that the
skilled artisan would have combined Giampapa’s and Bechtold-Peter’s
disclosures.
Further, we are also persuaded by Appellants’ argument that the
coating of Giampapa is not identical to the coating of the claimed invention.
FF17. Where the claimed invention includes HPMC and HPM and excludes
components such as PEG, each embodiment of a film coating disclosed by
Giampapa includes all three components. The Examiner did not provide
sufficient evidence that Giampapa’s film coating would behave identically to
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that of the claimed invention so as to protect probiotic microorganisms
passing through the stomach.
For the above reasons, we reverse the rejection of claims 1—10, 12—19,
21, and 23—26 over Giampapa and Bechtold-Peters.
Obviousness over Giampapa, Bechtold-Peters, and Robinson
The Examiner determined that claims 1, 22, and 23 would have been
obvious over Giampapa, Bechtold-Peters, and Robinson combined, finding,
again, that Giampapa taught an oral dosage formulation with a probiotic
microorganism and with a coating having HPMC and HPC. See Final
Action 5—6; FF15—FF17. The Examiner again noted that Giampapa did not
teach to exclude PEG (relevant to claim 1 as an express limitation and to
claim 23 by virtue of its claimed fimction/result). Final Action 6. While
again citing Bechtold-Peters as disclosing the claimed coating, the Examiner
also determined that Robinson taught pharmaceutical compositions with film
coatings made from HPMC and HPC. See Final Action 6—7; FF4—FF8. The
Examiner also noted that Giampapa does not teach the thickness of the
coating recited at claim 22, but determined that Robinson taught non-enteric
coatings (of HPMC/HPC) where thickness was routinely varied depending
on materials and desired lag time for (delayed) release of the active
component, finding that the claimed thickness range was an obvious
optimizable variable. See Final Action 7; FF9, FF11—FF14.
Appellants generally renew their arguments over the Giampapa-
Bechtold-Peters combination as relevant to the rejection also including
Robinson. App. Br. 9. Appellants argue Robinson teaches including PEG in
dosage forms. Id. (not persuasive, as Robinson is clear this is merely
optional—FF8, FF14). Appellants also argue that, while the Examiner relies
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on Robinson’s disclosure of stearate in its formulation, not all claims
rejected over the reference require stearate. Id. (i.e., claim 22). Appellants
argue that Robinson’s disclosure of film materials is generic and lists
components with “very different properties,” and so it is only with improper
hindsight that the rejection is made. Id. at 10. Regarding claim 23,
Appellants contend the coating disclosed in the Specification, which
includes two cellulose ethers with hydroxyalkyl groups and different
swelling/gel-formation behaviors, protects probiotics by delaying their
release until released into the intestine, which results in at least a 5-fold
increased survival rate compared to an uncoated formulation, which the prior
art combination does to address. Id. at 10-11. Regarding claim 22,
Appellants argue the combined prior art does not teach the “matched
combinations of coating agents,” and Robinson, the only reference
mentioning coating thicknesses, is too general to lead a skilled worker to the
specific matched combination of HPMC, HPC, and stearate agents. Id. at
11. These arguments are not persuasive.
While we found that one of skill in the art would not have combined
the rapid release coating of Bechtold-Peters with the probiotic components
of Giampapa, we conclude that Robinson remedies this deficiency by its
teaching of a delay-release formulation to protect its active component from
the hazards of the stomach by releasing only to the small intestine. FF4—
FF7, FF9.
Regarding claim 1, even though Bechtold-Peters teaches a rapid
release coating, we conclude Robinson teaches a coating of HPMC and
HPC, in various amounts and thicknesses, to provide a delayed-release
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formulation that would protect the probiotic microorganisms of Giampapa
(in disclosed dosages) in the same way it protects the omeprazole of its own
disclosure. FF4—FF17. There would have been motivation to combine the
Robinson and Giampapa disclosures because, as stated by Appellants, it is
crucial to protect probiotics from the stomach environment and doing so
with a coating of HPMC and HPC (and a stearate, but without PEG and
without an enteric component) as disclosed by Robinson provides this
crucial protection so as to allow a probiotic to survive to the small intestine.
FF1, FF3—FF14. Moreover, there would have been motivation to use a
probiotic complex, as taught by Giampapa, with a coating, as taught by
Robinson, because Giampapa teaches that there are important anti­
inflammatory benefits to be obtained from such probiotics and also that its
Lactobacillus and Bifidobacterium microorganisms are compatible with the
HPMC and HPC coating components of Robinson. FF6, FF15, FF17.
Regarding claim 22, we conclude Robinson teaches and suggests a
range of thicknesses for its HPMC/HPC coating and that such thicknesses
can be selected for desired control of the timing of active component release.
FF11—FF13. Further, Robinson teaches its coating components, e.g.,
HPMC, can be provided in varying amounts (% by wt.). FF14. Based on
such teachings, it would have been obvious to find the optimum value for
coating thickness, as claimed. “[Discovery of an optimum value of a result
effective variable in a known process is ordinarily within the skill of the art.”
In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants’ Specification
also confirms that coating thickness and amounts of components are
optimizable variables. FF2.
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Regarding claim 23, we conclude the coating taught and suggested by
Robinson is the same coating of the claim and as disclosed in the
Specification as achieving the claimed survival of the probiotic
microorganisms.
Where ... the claimed and prior art products are identical or
substantially identical ... the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. Whether the
rejection is based on “inherency” under 35 U.S.C. § 102, on
“prima facie obviousness” under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is
evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote
omitted). Here, it would be expected that the coating of Robinson would
necessarily protect the probiotic microorganisms of Giampapa through the
hazards of the stomach environment to then be safely and rapidly released in
the small intestine in the same way the Robinson coating protects
omeprazole. FF5, FF6, FF9. Without its protective coating, the Robinson
tablet core is an immediate-release formulation, which would release
probiotic (or omeprazole) into the stomach, where the environment would
cut the survival rate of microorganisms just as it was shown to do to the
uncoated comparison tablets described in the Specification. FF4—FF6;
Spec. 10.
For the reasons above, we affirm the rejection over Giampapa and
Robinson, with or without Bechtold-Peters.
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NEW GROUND OF REJECTION
As noted by Appellants in the Appeal Brief, “[cjlaim 26 has not been
rejected in view of Giampapa, Bechtold-Peters and Robinson.” App. Br. 8.
As a new ground of rejection, we find claim 26, which requires “a probiotic
microorganism” and “a coating comprising hydroxypropylmethylcellulose
and [] hydroxypropylcellulose in a weight ratio to one another of 90:10 to
10:90,” but explicitly “does not contain a gastric juice resistant coating and
does not contain a PEG softener,” would have been obvious over the
Robinson-Giampapa combination, with or without Bechtold-Peters.
As discussed above, it would have been obvious to combine
Giampapa and Robinson to use the HPMC/HPC, non-enteric coating in a
delayed-release probiotic formulation to protect the probiotic
microorganisms in the stomach environment and deliver them to the small
intestine. We incorporate our findings of fact and discussion, set forth
supra, here.
Further, the claimed ratio range of claim 26 is extremely broad, failing
to include only extreme differences in amounts of HPMC and HPC.
Robinson teaches and suggests incorporating HPMC and HPC in its coating
and teaches and suggests adjusting the amounts of such components. FF11—
FF14.
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. These cases have consistently held
that in such a situation, the applicant must show that the
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particular range is critical, generally by showing that the claimed
range achieves unexpected results relative to the prior art range.
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citations omitted,
emphasis in original). Here, there is no evidence that the claimed range of
ratios is critical or non-obvious over the prior art, which discloses the
combination of coating components as claimed. Appellants’ Specification
also confirms that the ratio of HPMC to HPC is optimizable. FF2.
SUMMARY
The obviousness rejection over Giampapa and Bechtold-Peters is
reversed.
The obviousness rejection over Giampapa, Bechtold-Peters, and
Robinson is affirmed.
We reject claim 26 under 35 U.S.C. § 103(a) as unpatentable over
Robinson and Giampapa, with or without Bechtold-Peters, in a new ground
of rejection.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b), which provides, “[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:
When the Board enters such a non-final 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 amend­
ment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter
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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 Patent Examining Procedure § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED-IN-PART; 37 C.F.R, $ 41.50(b)
18