Jean Krutmann

Patent Trials and Appeals Board

Mar 24, 2020

13038641 - (R) (P.T.A.B. Mar. 24, 2020)

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.
13/038,641 03/02/2011 Jean Krutmann BITA0104PUSA1 9227
62836 7590 03/24/2020
Brooks Kushman P.C. / BERLINER & ASSOCIATES
1000 Town Center, 22nd Floor
22nd Floor
Southfield, MI 48075
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
03/24/2020 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEAN KRUTMANN
Appeal 2019-000294
Application 13/038,641
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN G. NEW,
RACHEL H. TOWNSEND Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
This is Request for Rehearing Pursuant under 37 C.F.R. § 41.52
(“Req. Reh’g”) (filed Jan. 27, 2020) of the Decision on Appeal (“Dec.”)
(Entered Nov. 26, 2019). We have jurisdiction under 35 U.S.C. § 6(b). The
rehearing is DENIED.

Appeal 2019-000294
Application 13/038,641

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Discussion
In the Decision on Appeal, the Examiner’s final rejection of claims 11
and 13 as failing to comply with the enablement requirement was affirmed.
Dec. 2. Claim 11, the only independent claim, is reproduced below.
11. A method for counteracting lung tissue exposure to
suspended particulate in a patient in need thereof, comprising
administering by inhalation an effective amount of at least one
osmolyte selected from ectoine, hydroxyectoine or a
pharmacologically compatible salt thereof to the patient.

Appellant filed a Request for Rehearing of the Board’s decision to
affirm the rejection of the claims. Appellant contends that we misinterpreted
claim 11. Specifically, Appellant contends that that “the Board either
ignored, defined in isolation, or misinterpreted: (a) ‘counteracting,’ (b)
‘prophylactic effect’ and ‘exposure,’ and (c) ‘also suitable for the treatment
of diseases.’” Req. Reh’g 2.
In the Decision, we interpreted “counteracting” to mean “having a
restraining or neutralizing effect.” Dec. 4. Based on this interpretation and
the disclosure in the Specification, we found that “counteracting lung tissue
exposure to suspended particulate in a patient” by administering one of the
recited osmolytes included both disease prevention and disease treatment.
Dec. 5. As explained in the Decision:
When a disease is treated by the recited osmolyte, the noxious
effects of the particulate are counteracted because their disease-
causing effects are neutralized (dictionary definition of
“counteract”). The result of administering the osmolyte is to
treat the disease and therefore the noxious influence of
suspended particulate is counteracted, even if the treatment
occurs after the particulate has caused the disease and the
treatment treats a secondary result (e.g., tissue injury) of the
particulate activity.
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Application 13/038,641

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Dec. 6.
Appellant did not identify a flaw in this reasoning. Rather, Appellant
repeats the same argument about there being a distinction between
“prophylactic counteracting and treating” (Req. Reh’g 2) which was
addressed in the Decision. Appellant also states:
For example, nowhere in the specification will one find any of
the following diseases that the Examiner touted and the Board
bought into: on page 4 of the Answer: “asbestosis, silicosis,
cystic fibrosis, cancers such as mesothelioma, squamous, small
cell lung cancer, etc.” then, “antiangiogenic therapies” on page
5. None of these diseases are ever mentioned in claim 11.
Req. Reh’g 2.
None of these diseases need to be mentioned in the claim. The reason
that certain diseases were identified in the Examiner’s Answer and Decision
on Appeal was to illustrate that the scope of the claim is broad because it
includes “treatment” of any disease. The examples were illustrative to show
that many different types of diseases fall within the claim.
Appellant further argues that it “chose to not claim treating but to
claim prophylactically counteracting exposure to suspended particulate, a
concept not shown by prior art.” Req. Reh’g 2. This argument does not
persuade us that there was any misapprehension in the Board’s Decision.
The claim, as reproduced above, does not recite the term “prophylactically
countering.” The claim recites “counteracting lung tissue exposure to
suspended particulate in a patient.” The term “prophylactically” does not
appear in the claim. Therefore, the claim is not expressly limited to
prophylaxis.
The Decision on Appeal explained why we construed the claim to
include disease treatment. Appellant did persuasively demonstrate that such
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Application 13/038,641

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an interpretation of the claim is unreasonable. Appellant attempts to import
the word “prophylactic” into the claim, but for the reasons discussed in the
Decision on Appeal, we reject this narrow reading of the claim.
Appellant states that, while the Specification mentioned that the
claimed osmolytes are suitable for the treatment of diseases, the “only
reasonable interpretation is to give the claims the scope actually stated in
claim 11, namely that ‘counteract’ is prophylactic, i.e., to prevent disease,
not treat it.” Req. Reh’g 3. For the reasons discussed in the Decision,
namely that counteracting the noxious effect of particulates when a patient
has the disease would result in disease treatment, we do not agree
Appellant’s interpretation of the claim is the broadest, most reasonable, one.

Disease prevention
The Decision also stated that “even if treatment were excluded, the
same rationale [of lack of enablement] applies to disease prevention and
other neutralizing effects of the osmolyte.” Dec. 8. We explained that the
broad concentration range of the osmolyte covered by the claim, the failure
to disclose an effective amount of osmolyte, and the failure to disclose of
frequency of administration of the osmolyte, indicates that the guidance in
the Specification to achieve the stated purpose of the claims is inadequate to
enable the full scope of the claim. Dec. 8. As stated in the Decision:
[T]he only examples (Wands factor 3) disclosed in the
Specification are Examples 1 and 2 of making gas and powder
inhalants comprising ectoine and hydroxyectoine. Spec. 7.
There is no example in which either osmolyte, alone or both
combined as in the inhalants of Examples 1 and 2, are used to
counteract a particulate in the lung, let alone prevent or treat a
condition caused by the particulate.
Dec. 8 (emphasis added.)
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Application 13/038,641

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The Decision also stated that Appellant:
did not explain how this high level of skill [in the art] and the
lung studies would enable one of ordinary skill in the art to
carry out the full scope of the claim, such as to determine the
dosages and frequency of administration to prevent
inflammation and malignant pulmonary disease.
Dec. 10 (emphasis added).
In sum, the Decision also found the Specification deficient in enabling
the prophylactic aspect of the claims.
In light of the above, we conclude that Appellant did not identify in
the Request for Rehearing any points that were misapprehended or
overlooked in the Decision. Accordingly, the Rehearing is denied.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
11, 13 112 Enablement 11, 13
DENIED