Ex Parte Klocke et al

Patent Trial and Appeal Board

Dec 13, 2018

12761993 (P.T.A.B. Dec. 13, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/761,993 04/16/2010
26875 7590 12/17/2018
WOOD, HERRON & EV ANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI, OH 45202
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Stefan Klocke
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.
GGS-OlBl 2418
EXAMINER
CABRAL, ROBERTS
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
12/17/2018 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):
usptodock@whe-law.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEP AN KLOCKE, HARALD WALTER,
and ALEXANDER STUCK1
Appeal2017-010602
Application 12/761,993
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge FLAX.
Opinion Dissenting-in-Part filed by Administrative Patent Judge PRATS.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method of forming a pharmaceutical dosage. The Examiner's
rejections of claims 11-24 and 26 under 35 U.S.C. §§ 102(b) and 103(a) are
appealed. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 The Real Party in Interest is identified as "I-Property Holding Corp."
Appeal Br. 1. We herein refer to the Specification of Apr. 16, 2010
("Spec."); Final Office Action of May 26, 2016 ("Final Action"); Appeal
Brief of Feb. 27, 2017 ("Appeal Br."); Examiner's Answer of June 7, 2017
("Answer"); and Reply Brief of Aug. 7, 2017 ("Reply Br.").
Appeal2017-010602
Application 12/761,993
STATEMENT OF THE CASE
Independent claim 11, reproduced below, is representative:
11. A method of forming a pharmaceutical dosage form
compnsmg:
impressing, on at least one of a surface and an interface of the
dosage form, an area with at least one micro- and/ or
nano structure;
the dosage form comprising a quantity and distribution of
ingredients so as to enhance an optical contrast effect caused by
the impressed micro and/or nanostructure, so that the micro-
and/or nanostructure is observable by the human eye,
wherein the impressing is defined by only direct compression of
a mixture of selected ingredients with a punching tool to create
the solid pharmaceutical dosage form, with the direct
compression performed at room temperature without heating and
without modifying the physical nature of the material in the
mixture, the punching tool having a micro and/or nano-structured
surface formed in a tool surface geometry, and wherein particles
of the mixture of selected ingredients are sized such that at least
some of the particles are reconfigured or deformed by the
compressing, these particles thereby taking the shape of the
micro and/or nano-structured surface of the punching tool.
Appeal Br. 12 (Claims Appendix).
The following rejections are on appeal:
Claims 11, 13-17, and 26 stand rejected under 35 U.S.C. § I02(b) as
anticipated by Walter. 2 Final Action 2.
Claims 11-17 and 26 stand rejected under 35 U.S.C. § I03(a) over
Walter. Id. at 5.
2 WO 2006/027688 Al (published Mar. 16, 2006) ("Walter").
2
Appeal2017-010602
Application 12/761,993
Claims 11, 13-17, 19-22, and 26 stand rejected under 35 U.S.C.
§ I03(a) over Walter and McCormick. 3 Id.
Claims 11, 13-17, 23, 24, and 26 stand rejected under 35 U.S.C.
§ I03(a) over Walter and Vergnault. 4 Id. at 8.
Claims 11, 13-18, 20, and 26 stand rejected under 35 U.S.C. § I03(a)
over Walter and Creevy. 5 Id. at 10.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability.
[Only once] that burden is met, the burden of coming forward with evidence
or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992).
"Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). "The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). However, "obviousness requires a suggestion of all limitations
in a claim." CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333, 1342 (Fed.
Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
The Examiner determined that Walter anticipated claims 11, 13-1 7,
and 26 and would have rendered these claims and claim 12 obvious, and
3 Douglas McCormick, Special Report Evolutions in Direct Compression,
PHARMA. TECH. 52---62 (April 2005) ("McCormick").
4 US 2007/0110807 Al (published May 17, 2007) ("Vergnault").
5 US 2,444,282 (issued June 29, 1948) ("Creevy").
3
Appeal2017-010602
Application 12/761,993
further that combinations of Walter with McCormick, Vergnault, or Creevy
would have rendered the other claims obvious. Each rejection, however,
relies on the Walter reference for a disclosure of the subject matter of
independent claim 11, upon which all other claims depend.
Appellants present a persuasive argument, which is "Walter actually
fails to teach the enhancement of an optical contrast effect," or, as claimed,
"the dosage form comprising a quantity and distribution of ingredients so as
to enhance an optical contrast effect caused by the impressed micro and/or
nanostructure, so that the micro-and/or nanostructure is observable by the
human eye." Appeal Br. 4. The Examiner's position is that Walter's
teaching that optical effects can be modified, but can still be seen teaches
this claim element and that modification equates to enhancement. Final
Action 3; Answer 2.
Merriam-Webster defines "enhance" as "to increase or improve in
value, quality, desirability, or attractiveness." 6 We conclude the term's
usage in Appellants' claims comports with this ordinary meaning. The term
"modify" is defined by the dictionary to mean "to make minor changes in"
and "to make basic or fundamental changes in often to give a new
orientation to or to serve a new end. "7 Thus, the two terms are not
synonyms and the Examiner's rationale does not establish a prima facie case
for anticipation or obviousness in reliance on Walter, which does not teach
6 MERRIAM-WEBSTER, enhance, https://www.merriam-
webster.com/dictionary/enhance, visited Dec. 4, 2018.
7 MERRIAM-WEBSTER, modify, https://www.merriam-
webster.com/dictionary/modify, visited Dec. 4, 2018.
4
Appeal2017-010602
Application 12/761,993
improving optical effects based on the ingredients of a pharmaceutical
dosage form.
For this reason, we must reverse the Examiner's rejections for
anticipation and obviousness.
SUMMARY
The anticipation and obviousness rejections are each reversed.
REVERSED
5
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEP AN KLOCKE, HARALD WALTER,
and ALEXANDER STUCK
Appeal2017-010602
Application 12/761,993
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
PRATS, Administrative Patent Judge, dissenting-in-part.
I respectfully dissent from my colleagues' decision to reverse the
Examiner's rejection of claims 11, 13-17, and 26 as anticipated by Walter
(WO 2006/027688 Al (published Mar. 16, 2006) ("Walter")). I would
affirm that rejection.
Claim 11 is the only independent claim subject to the Examiner's
anticipation rejection. Appellants do not dispute that Walter describes a
process that includes the sole step recited in claim 11-using a punching
tool at room temperature to impress a micro- and/or nanostructure into the
surface of a pharmaceutical dosage form. See Appeal Br. 4---6; Reply Br. 2-
3.
Rather, Appellants contend only that the Examiner erred in finding
that Walter's process meets the requirement in claim 11 for the impressed
Appeal2017-010602
Application 12/761,993
dosage form to "include[] 'a quantity and distribution of ingredients so as to
enhance an optical contrast effect caused by the impressed micro and/ or
nano structure."' Appeal Br. 4 ( quoting claim 11 ); Reply Br. 2.
I do not find Appellants' argument persuasive.
Viewing the claim limitation at issue in full, Appellants' claim 11
requires the impressed dosage form to "compris[ e] a quantity and
distribution of ingredients so as to enhance an optical contrast effect caused
by the impressed micro and/or nanostructure, so that the micro- and/or
nanostructure is observable by the human eye." Appeal Br. 12 (claim 11;
emphasis added).
Thus, when read in its entirety, the claim limitation at issue only
requires the impressed dosage form to include a quantity and distribution of
ingredients that enhances the optical contrast effect of the impressed
microstructure/nanostructure "so that the micro- and/ or nano structure is
observable by the human eye." Id.
As the Examiner found, Walter discloses that the
microstructure/nanostructure impressed into the surface of its dosage form is
visible to the human eye. See Walter 3 (disclosing that, despite the presence
of a transparent coating, the imprinted "optical effects are modified but still
can be seen"). I therefore agree with the Examiner that the process
described in Walter uses a dosage form with a quantity and distribution of
ingredients that enhances the optical contrast effect of the impressed
microstructure/nanostructure, "so that the micro and/or nanostructure is
observable by the human eye" (Appeal Br. 12 (claim 11)), which is all that
Appellants' claim 11 requires.
2
Appeal2017-010602
Application 12/761,993
In arguing that Walter does not anticipate claim 11, Appellants
repeatedly ignore the fact that, by its express terms, claim 11 only requires
the optical contrast effect enhancement to render the impressed
microstructure/nanostructure observable by the human eye. See Appeal Br.
4 ( quoting limitation at issue but not including recitation that enhancement
results in impressed microstructure/nanostructure being observable by
human eye); Reply Br. 2 (same).
It is well settled that it is improper to ignore express language in a
claim at issue. See In re Angstadt, 537 F.2d 498, 501 (CCPA 1976) ("[W]e
must give effect to all claim limitations."); In re Wilder, 429 F.2d 447, 450
(CCP A 1970) ("[E]very limitation positively recited in a claim must be
given effect in order to determine what subject matter that claim defines.").
Because Appellants' assertion of error on the part of the Examiner in this
instance ignores express language in claim 11, Appellants do not persuade
me that the Examiner's finding of anticipation is erroneous.
As Appellants contend (see Appeal Br. 5), the Specification explains
that Appellants' invention involves the discovery that, when impressing a
microstructure or nanostructure into the surface of a dosage form, the
presence of a dye enhances the ability to discern visually the presence of the
pattern impressed into the surface of the dosage form. See Spec. 4 ("The
applicant found that only dry-compression techniques using certain pressure
parameters can be employed in order to reliably obtain microreliefs in
pharmaceutical dosage forms. In addition, the use of certain dyes is
necessary, as the resulting colors strongly increase the human perception of
the optical microstructures. ") ( emphasis added).
3
Appeal2017-010602
Application 12/761,993
Although the contrast effect-enhancing limitation at issue in claim 11
might, thus, encompass the presence of a ( apparently critical) dye, claim 11
does not expressly recite the use of a dye to improve the visual discernibility
of the impressed micro/nanostructures. See Appeal. Br. 12.
I am not persuaded that it is proper to import a requirement for a dye,
or any other contrast-enhancing ingredient, from the Specification into claim
11, where the express language of claim 11 requires only that the dosage
form ingredients render the impressed micro/nanostructure observable by the
human eye. See In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299
(Fed. Cir. 2007) ("[W]hile 'the specification [should be used] to interpret the
meaning of a claim,' courts must not 'import[ ] limitations from the
specification into the claim.' ... [I]t is improper to 'confin[ e] the claims to
th[ e] embodiments' found in the specification .... ") ( quoting Phillips v.
AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (citations omitted,
bracketed text in internal quotes in original).
It is well settled that during examination the PTO must interpret terms
in a claim using "the broadest reasonable meaning of the words in their
ordinary usage as they would be understood by one of ordinary skill in the
art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant's specification." In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
As explained in In re Zletz, 893 F.2d 319,322 (Fed. Cir. 1989), the
reason for this rule of claim interpretation is that "during patent prosecution
4
Appeal2017-010602
Application 12/761,993
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed."
In the present case, as discussed above, Appellants' assertions of error
on the part of the Examiner rely on an improper claim interpretation that
ignores express language in claim 11. As discussed above, Appellants also
improperly seek, at least impliedly, to import limitations not present in claim
11 from the Specification. Appellants do not persuade me, therefore, that
the Examiner erred in finding Walter describes a process having all of the
steps and features of Appellants' claim 11. Accordingly, I would affirm the
Examiner's rejection of claim 11, and its dependent claims 13-17, and 26, as
anticipated by Walter.
Except as to claim 12, discussed below, I would also affirm each of
the remaining rejections entered by the Examiner, all of which are for
obviousness. In particular, other than claim 12, Appellants argue only that
the references cited by the Examiner fail to remedy the alleged deficiency of
Walter in relation to claim 11, discussed above. See Appeal Br. 6-11. As
discussed above, however, I am not persuaded that Walter fails to describe a
process having all of the steps and features of Appellants' claim 11.
Accordingly, except as to claim 12, I would affirm each of the Examiner's
obviousness rejections.
Claim 12 recites "[t]he method of claim 11, wherein at least one of the
ingredients to enhance the optical contrast includes a dye." Appeal Br. 12.
Claim 12, thus, encompasses a process in which a dosage form having a
dyed surface is impressed with a microstructure/nanostructure according to
the teachings in Walter.
5
Appeal2017-010602
Application 12/761,993
I agree with the Examiner (see Final Act. 5 (entered May 26, 2016))
that a claim reciting a combination of known prior art elements functioning
in an expected manner is obvious under§ 103. See KSR Int'! Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007) ("[W]hen a patent 'simply arranges old
elements with each performing the same function it had been known to
perform' and yields no more than one would expect from such an
arrangement, the combination is obvious.") (quoting Sakraida v. Ag Pro,
Inc., 425 U.S. 273 (1976)).
In the present case, as discussed in Walter, it was known in the art to
impress the surface of a dosage form with a visible microstructure. As to the
other element required by claim 12, Appellants' Specification discloses that
dyed dosage forms were known in the prior art. See Spec. 8 ("While most
pharmaceutical pills are white, notable examples such as Viagra® are blue,[]
others are red.").
As to the dye component required by Appellants' claim 12, however,
the Examiner relies on teachings on page 1 of Walter. Final Act. 5 ( citing
Walter 1:9).
As Appellants argue, when viewed in context, the portion of page 1 of
Walter cited by the Examiner relates to the use of dyes in labels associated
with the product, as opposed to using dyes in the dosage form itself:
"Products or articles are currently protected against counterfeiting
predominantly by attaching security labels to the products or to the
packaging of the product. Such labels possess, for example, optical variable
devices like holograms or colour changing inks, fluorescent dyes, special
6
Appeal2017-010602
Application 12/761,993
printing techniques like microprinting and the like." Walter 1: 6-12
( emphasis added).
Because the Examiner's rejection of Appellants' claim 12 fails to
provide an evidentiary basis for finding that it was known in the art to
include dyes on the surface of pharmaceutical dosage forms, as required by
claim 12, I am constrained to agree with my colleagues that the Examiner's
rejection of claim 12 should be reversed.
In sum, for the reasons discussed, I would affirm each of the
Examiner's rejections, except for the Examiner's rejection of claim 12 for
obviousness over Walter. I therefore respectfully dissent.
7