Ex Parte FRANK et al

Patent Trial and Appeal Board

Nov 9, 2018

13005810 (P.T.A.B. Nov. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/005,810 01/13/2011
23872 7590 11/09/2018
MCGLEW & TUTTLE, PC
P.O. BOX 9227
SCARBOROUGH STATION
SCARBOROUGH, NY 10510-9227
FIRST NAMED INVENTOR
Franz FRANK
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.
73807 3274
EXAMINER
ALTER, MITCHELLE
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
11/09/2018 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
Ex parte FRANZ FRANK, MARAL HAAR,
JURGEN MANIGEL, KAI KUCK, SUSANNE STAHLKOPF,
MARCEL VOIGT, THOMAS BOUILLON,
MARTIN LUGINBUHL, and PETER SCHUMACHER
Appeal2017-000434
Application 13/005,810
Technology Center 3700
Before STEFAN STAICOVICI, EDWARD A. BROWN, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Franz Frank et al. ("Appellants") appeal under 35 U.S.C. § 134(a)
from the Examiner's decision rejecting claims 38--42, 44--58, 62, and 64. 1
An oral hearing, pursuant to 3 7 C.F .R. § 41.4 7, was held on October 31,
2018. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and ENTER A NEW GROUND OF
REJECTION pursuant to our authority under 37 C.F.R. § 41.50(b ).
1 Drager Medical GmbH and Inselspital Bern, Direktion Lehre und
Forschung are identified as the real party in interest. Appeal Br. 1.
Appeal2017-000434
Application 13/005,810
THE CLAIMED SUBJECT MATTER
Appellants' invention "pertains to a process for monitoring a patient
being anesthetized by means of at least one anesthetic with the use of a
monitoring device." Spec. ,r 2. Claim 38, reproduced below, is illustrative
of the claimed subject matter.
3 8. An anesthetic process comprising the steps of:
administrating a plurality of active anesthetic ingredients to a
patient undergoing a painful procedure;
determining a concentration of each of the active
anesthetic ingredients at a site of action;
determining an action of each of the active anesthetic
ingredients from the determined concentrations of each active
anesthetic ingredient at the site of action;
determining an interaction relationship between each of
the active anesthetic ingredients;
combining the actions of the plurality of active anesthetic
ingredients according to the interaction relationship to obtain a
combined potency of all the plurality of active anesthetic
ingredients;
converting said combined potency to a Noxious Stimulus
Response Index (NSRI), said NSRI being a one-dimensional
parameter and having a full scale range with a first endpoint
of said range indicating an alert and non-anesthetized patient,
and with a second endpoint of said range indicating a deepest
anesthesia;
displaying the NSRI to an operator controlling said
administering of the plurality of active anesthetic ingredients.
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REJECTIONS 2
1) Claims 38, 39, 56, 62, and 64 are rejected for failing to comply
with the enablement requirement of 35 U.S.C. § 112, first
paragraph. 3
2) Claims 38, 39, 45, 56, 62, and 64 are rejected as indefinite under
35 U.S.C. § 112, second paragraph.
3) Claims 38--42, 45-52, 54, 55, 57, and 64 are rejected under 35
U.S.C. § 102(b) as anticipated by Noah D. Syroid et al.
(Development and Evaluation of a Graphical Anesthesia Drug
Display, 96 Anesthesiology, 565-74 (2002)) ("Syroid").
4) Claim 44 is rejected under 35 U.S.C. § I03(a) as unpatentable over
Syroid.
5) Claims 53 and 56 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Syroid, Bouillon (US 2006/0081244 Al,
published Apr. 20, 2006), and Andrews (US 6,186,977 Bl, issued
Feb. 13, 2001).
DISCUSSION
Rejection 1
The Examiner finds that "the specification, while being enabling for
NSRI being calculated by equations 1 and 8, does not reasonably provide
enablement for the term 'NSRI"' because equations 1 and 8 are not
2 A rejection of claim 61 for failing to comply with the written description
requirement of 35 U.S.C. § 112, first paragraph, was withdrawn in the
Examiner's Answer. Ans. 7; Final Act. 2.
3 The Examiner states that claims 59---63 would be allowable if rewritten to
overcome the rejections under 35 U.S.C. § 112, second paragraph, and to
include all limitations of the base claim and any intervening claims. Final
Act. 8. Of these claims, however, only claim 62 is currently rejected.
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commensurate with the scope of the claims. Final Act. 2-3. Appellants
contend that NSRI is recited in the claims as "a parameter having a range
with one endpoint that indicates an alert and non-anesthetized patient, and
another endpoint that indicates a deepest anesthesia." Appeal Br. 11.
Appellants argue that equations 1 and 8 in the Specification enable the
claims and that one of "ordinary skill in the art, given the definition ofNSRI
in the claims, could convert the combined potency to a NSRI parameter
using a different conversion than that described in equations 1 and 8, without
undue experimentation." Id. Appellants submit that the preferred
embodiment described in paragraph 30 of Appellants' Specification "is an
inverted sigmoid function" and notes other types of inverted sigmoid
functions are known in the art. Id.
The Examiner responds that Appellants' Specification defines NSRI
"by equations 1 and 8 and no other definition or alternate method of
calculating NSRI is provided such that NSRI can only be equations 1 and 8."
Ans. 9. The Examiner asserts that "it would require undue experimentation
to derive the NSRI parameter by another method." Id
When rejecting a claim under 35 U.S.C. § 112 for lack of enablement,
the Examiner bears an initial burden of setting forth a reasonable explanation
as to why the scope of protection provided by the claim is not adequately
enabled by the description of the invention provided in the specification of
the application. See In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993).
The enablement provision in the first paragraph of 35 U.S.C. § 112 requires
that the full scope of a claim be enabled. ALZA Corp. v. Andrx Pharm.,
LLC, 603 F.3d 935, 943 (Fed. Cir. 2010). Determining whether any
necessary experimentation is undue involves consideration of many relevant
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factors including, but not limited to: (1) the breadth of the claims; (2) the
nature of the invention; (3) the state of the prior art; (4) the level of one of
ordinary skill; ( 5) the level of predictability in the art; ( 6) the amount of
direction provided by the inventor; (7) the existence of working examples;
and (8) the quantity of experimentation needed to make or use the invention
based on the content of the disclosure. In re Wands, 858 F.2d 731, 737 (Fed.
Cir. 1988).
The Examiner correctly notes that Appellants' Specification provides
two equations that can be used to determine NSRI. Spec. ,r,r 31, 45.
Appellants, however, argue that undue experimentation is not required to
determine NRSI by means other than equations 1 and 8 because, inter alia,
one of ordinary skill in the art would understand that other methods of
calculating NSRI are available and specifically directs us to other inverted
sigmoid functions that it asserts are known in the art. The Examiner does
not dispute that these other inverted sigmoid functions are known in the art
or adequately explain why undue experimentation would be required to use
these functions instead of equations 1 and 8. See Ans. 8-9. Even though
calculating NSRI using other known inverted sigmoid functions may require
some experimentation on the part of ordinarily skilled artisans, a disclosure
may nonetheless be enabling despite the need for experimentation. The test
is whether such experimentation is undue. In re Angstadt, 537 F.2d 498, 504
(CCPA 1976). The Examiner does not provide any analysis of the Wands
factors to support the assertion that undue experimentation would be
required. See Final Act. 2-3; Ans. 8-9.
In the absence of a persuasive analysis of the Wands factors, the
Examiner fails to provide adequate reasoning to support the assertion that
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Application 13/005,810
undue experimentation would be required to determine NSRI by a method
other than equations 1 and 8 in Appellants' Specification. Therefore, we do
not sustain this rejection.
Rejection 2
Claims 38, 39, 56, 62, and 64
The Examiner rejects these claims as indefinite because "the metes
and bounds of what constitutes NSRI are uncertain unless such term is
defined by equations 1 and 8." Final Act. 3.
Appellants contend that NSRI is a one dimensional parameter "that
has a full scale range with endpoints" and the endpoints of the recited range,
"[a]n alert and non-anesthetized patient" and "deepest anesthesia" are well
known in the art. Appeal Br. 14. Consequently, according to Appellants,
because the "the metes and bounds are certain, these claims are not
indefinite with regard to what constitutes NSRI." Id. The Examiner
responds that "the metes and bounds of what constitutes NSRI are uncertain
unless such term is defined by equations 1 and 8" and here "the end points
... are unrelated to the formula used to determine the NSRI numerical
parameter, but rather the formula defines the NSRI numerical parameter."
Ans. 9. For the following reasons, we do not sustain this rejection.
"[W]e apply the approach for assessing indefiniteness approved by
the Federal Circuit in Packard, i.e., '[a] claim is indefinite when it contains
words or phrases whose meaning is unclear."' Ex parte McAward, No.
2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017)
(precedential) (quoting In re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir.
2014)). The language in 35 U.S.C. § 112, second paragraph, "of
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Application 13/005,810
'particular[ity ]' and 'distinct[ ness ]' indicates[] claims are required to be cast
in clear-as opposed to ambiguous, vague, indefinite-terms." Packard,
7 51 F .3d at 1313 (internal citations omitted). "The definiteness inquiry
focuses on whether those skilled in the art would understand the scope of the
claim when the claim is read in light of the rest of the [S]pecification."
Union Pacific Resources Co. v. Chesapeake Energy Corp., 236 F.3d 684,
692 (Fed. Cir. 2001). The breadth of a claim, however, is not to be equated
with indefiniteness. See, e.g., In re Miller, 441 F .2d 689, 693 ( CCP A 1971 ).
In this case, Appellants' Specification explains that the "NSRI index
corresponds to the probability of a reaction or response of the patient to a
painful stimulus ... NSRI equals 100 in case of an alert and
non-anesthetized patient, and it has the value O in case of the deepest
anesthesia." Spec. ,r 32. As discussed, the Specification also provides 2
equations for determining NSRI. See id. ,r,r 31, 45. Although the claimed
term NSRI may be broad, we determine that the term is not unclear because
one of ordinary skill in the art would understand the scope ofNSRI when
read in light of the Specification. Therefore, we do not sustain this rejection.
Claim 45
The Examiner determines that "'interaction term' is indefinite because
the metes and bounds are uncertain and the instant Specification does not
provide a means to determine it." Final Act. 3. Appellants respond that
"interaction term" is not indefinite because the Specification provides
several interaction terms that are combined with the anesthetic efficacy to
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determine a combined potency. Appeal Br. 18-19 (citing Spec. pp. 15-18).4
For the following reasons, we sustain the rejection of claim 45 as indefinite.
Claim 45, which depends from claim 38, provides that the combined
potency "is determined based on a mean anesthetic efficacy of the active
ingredients used and an interaction term." Claim 3 8 recites an "interaction
relationship" is used "to obtain a combined potency." "[I]nteraction term"
appears in paragraph 32 of Appellants' Specification in connection with
determining the combined potency N. See Spec. ,r 32. Appellants do not
direct us to any special definition in the Specification of "interaction term"
or any portion of the Specification that draws a distinction between an
"interaction relationship" recited in claim 3 8 and an "interaction term"
recited in claim 45. Id. It is unclear from the claims and Specification the
metes and bounds of the phrase "interaction term." Further, it is unclear
whether it is different than "interaction relationship" and, consequently,
whether its inclusion in claim 45 adds any additional limitation to claim 38.
Consequently, we agree with the Examiner that the term would be unclear to
one of ordinary skill in the art after reading the claims and Specification.
Therefore, we sustain the rejection of claim 45 as indefinite under 35 U.S.C.
§ 112, second paragraph.
Rejection 3
The Examiner finds that Syroid anticipates independent claims 3 8 and
64 including disclosing the step of "determining an interaction relationship
between each of the active anesthetic ingredients." Final Act. 4 ( citing
Syroid, p. 566, 2: 12-p. 567, 1:7, Fig. 2). Appellants contend that Syroid
4 Appellants indicate a willingness to remove "interaction term" from claim
45 if prosecution continues. Appeal Br. 19.
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does not anticipate claim 3 8 or claim 64 because it does not disclose
"determining an 'interaction relationship."' Appeal Br. 15. Appellants
argue that the claims require "determining ... how the active anesthetic
ingredients actually 'interact."' Id. According to Appellants, Syroid "does
state that a combined effect is calculated ... but this combined effect does
not include determining an interaction relationship." Id. Further, because,
according to Appellants, Syroid does not disclose "determining an
interaction relationship," Syroid does not use the "interaction relationship to
determine a combined potency." Id. at 16.
The Examiner responds that Appellants' Specification "teaches [that]
the interactions can be additive." Ans. 11 (citing Spec. ,r 25) 5. Based on this
teaching, the Examiner maintains the rejection because the broadest
reasonable interpretation of "interaction relationship" includes adding the
effects of the ingredients and the limitation is, therefore, "met by Syroid's
teaching of using an additive property." Id. For the following reasons, we
do not sustain the rejection of claim 38.
We agree with the Examiner that, based on paragraph 25 of the
Specification, the broadest reasonable interpretation of "interaction
relationship" encompasses adding the potency of the active ingredients, if
appropriate, as well as taking into account synergistic or antagonistic effects
of the ingredients in combination. See Spec. ,r 25 ("the actions of the active
ingredients being used are combined corresponding to the type of interaction
of these active ingredients, for example, either additively, synergistically or
antagonistically."). However, we do not agree with the Examiner's finding
5 The Examiner refers to paragraph 33 of the Specification but that appears
to be a typographical error.
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that Syroid discloses determining an interaction relationship between each of
the active ingredients using an additive property. Ans. 11. The Examiner
relies on the following description in Syroid and Figure 2 to support this
finding. Final Act. 4. Syroid provides that
For simplicity, we calculate the combined effect using the sum
of the predicted effect-site concentrations ... [ of] each drug
(i.e., the drug display does not incorporate drug-drug synergism
or antagonism). If the total effect-site concentrations of all
drugs are greater than 100%, then the contributions from each
drug become a fraction of the total.
Syroid, p. 566, 2: 12-p. 567, 1:7, Fig. 2. Although Syroid refers to summing
the effects of the active ingredients, Syroid states that this is done for
simplicity and does not incorporate any synergistic or antagonistic effects
caused by ingredient interaction. Further, the percentages of the ingredients
shown in Figure 2 of Syroid are reduced in the case where the total effect of
all ingredients exceeds 100%. This supports Appellants' arguments that
Syroid's summation does not disclose an actual interaction relationship
between the individual ingredients because one of ordinary skill in the art
would understand that a total effect greater than 100% does not account for
antagonistic effects of the ingredients. The Examiner's finding that Syroid
anticipates claim 3 8 and claim 64 is not supported by the requisite
preponderance of the evidence. We, thus, do not sustain the rejection of
independent claims 38 and 64 and of claims 39--42, 45-52, 54, 55, and 57
which depend from claim 3 8.
Rejection 4
Claim 44 depends from claim 38. Claims App. 4. The Examiner
rejects claim 44 as unpatentable over Syroid. Final Act. 7-8. The
Examiner's additional findings from Syroid in the rejection of claim 44 fail
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to cure the deficiencies in the rejection of claim 38 discussed supra. Id.
We, thus, do not sustain the rejection of claim 44 as unpatentable over
Syroid.
Rejection 5
Claims 53 and 56 depend from claim 38. Claims App. 4--5. The
Examiner rejects claims 53 and 56 as unpatentable over Syroid, Bouillon,
and Andrews. Final Act. 8. The Examiner's findings based on the
disclosure of Bouillon and Andrews fail to cure the deficiencies in the
rejection of claim 38 discussed supra. Id. We, thus, do not sustain the
rejection of claims 53 and 56.
NEW GROUND OF REJECTION
We enter a new ground of rejection of claims 40 and 41 as indefinite
under 35 U.S.C. § 112, second paragraph.
Claim 40 depends from claim 3 8 and recites steps of "combining the
actions for each of the active anesthetic ingredients in each class to
determine a class potency," "determining an interaction relationship between
the different classes of active anesthetic ingredients," and then "combining
the class potencies according to the interaction relationship." Claims App.
3. Claim 3 8 recites "determining an interaction relationship between each of
the anesthetic ingredients." Id. It is unclear which of the interaction
relationships recited in claims 3 8 and 40 is used in claim 40 when combining
the class potencies. In addition, claim 3 8 recites "converting said combined
potency to a Noxious Stimulus Response Index." It is unclear, for claim 40,
whether the class potency recited in claim 3 8 or the class potency recited in
claim 40 is converted to a Noxious Stimulus Response Index. For these
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reasons, we enter a new ground of rejection against claim 40 and claim 41,
which depends from claim 40, as indefinite under 35 U.S.C. § 112, second
paragraph.
DECISION
The Examiner's rejection of claims 38, 39, 56, 62, and 64 for failing
to comply with the enablement requirement of 35 U.S.C. § 112, first
paragraph, is reversed.
The Examiner's rejection of claims 38, 39, 56, 62, and 64 as indefinite
under 35 U.S.C. § 112, second paragraph, is reversed.
The Examiner's rejection of claim 45 as indefinite under 35 U.S.C.
§ 112, second paragraph, is affirmed.
The Examiner's rejection of claims 38--42, 45-52, 54, 55, 57, and 64
under 35 U.S.C. § 102(b) is reversed.
The Examiner's rejections of claims 44, 53, and 56 under 35 U.S.C.
§ 103(a) are reversed.
We enter a NEW GROUND OF REJECTION of claims 40 and 41 as
indefinite under 35 U.S.C. § 112, second paragraph.
FINALITY OF DECISION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 4I.50(b). 37 C.F.R. § 4I.50(b) 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, Appellants, within
two months from the date of the decision, must exercise one of the following
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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
[E]xaminer unless an amendment or new Evidence not
previously of Record is made which, in the opinion of the
[E]xaminer, overcomes the new ground of rejection designated
in this decision. Should the examiner reject the claims, ...
[Appellants] 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 new grounds of rejection can be
found in the MANUAL OF PATENT EXAMINING PROCEDURE§ 1214.01 (9th
Ed., Rev. 08.2017, Jan. 2018).
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. § 4I.50(b)
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