Ex Parte Ei-Habbal

Patent Trial and Appeal Board

Oct 13, 2016

12920345 (P.T.A.B. Oct. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/920,345 08/31/2010
11982 7590 10/17/2016
Bay State IP, LLC
One Boston Place
201 Washington St, Suite 2600
Boston, MA 02108
FIRST NAMED INVENTOR
Magdi Ei-Habbal
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.
1001.55.MEH 2897
EXAMINER
WORSHAM, JESSICA N
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
10/17/2016 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):
patents@baystatepatent.com
abruno@baystatepatent.com
gmacinnis@baystatepatent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MAGDI EI-HABBAL
Appeal2015-004051
Application 12/920,345
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving an antiviral
composition comprising zinc and trimethoprim. The Examiner rejected the
claims as indefinite, as not further limiting, as anticipated, and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"A variety of agents are associated with acute viral respiratory tract
infections (VR TI) ... The clinical syndromes of acute VR TI range from
1 Appellant identify the Real Party in Interest as Dr. Magdi El-Habbal (see
Br. 3).
Appeal2015-004051
Application 12/920,345
mild illnesses such as the common cold to severe, potentially life-threatening
conditions such as severe influenza A infection" (Spec. 1:4--10).
"Thus, there is a need for a treatment that is effective when viral
disease strikes, that is easily administered, is rapidly acting and terminates
the illness in a short time" (Spec. 2:6-8).
The Claims
Claims 21, 23-31, 3 3, and 3 5 are on appeal. 2 Claim 21 is
representative and reads as follows:
21. An antiviral composition comprising zinc and
trimethoprim wherein the weight ration [sic] of the zinc to the
trimethoprim is from about 1 :3 to about 1 :7.
The Issues
A. The Examiner rejected claims 27, 30, 31, 33, and 35 under 35 U.S.C.
§ 112, second paragraph as indefinite (Final Act. 3-5).
B. The Examiner rejected claims 23, 31, 33, and 35 under 35 U.S.C.
§ 112, fourth paragraph (Final Act. 6).
C. The Examiner rejected claims 21, 23-31, 33, and 35 under 35 U.S.C.
§ 102(b) as anticipated by Sim63 (Final Act. 7-8).
2 The Examiner objected to the Specification (Final Act. 2-3). However, the
propriety of the Examiner's objections relate to petitionable matters and not
to appealable matters. Objections to the Specification are petitionable
matters under 37 C.F.R. § 1.181 to the Director of the USPTO. See MPEP
§ 706.01; the "Board will not hear or decide issues pertaining to objections
and formal matters which are not properly before the Board." Accordingly,
we will decline to address the objections of record.
3 Simo et al., Interactions of metal ions with a 2,4-diaminopyrimidine
derivative (trimethoprim) Antibacterial studies, 81 J. INORGANIC
BIOCHEMISTRY 275-283 (2000).
2
Appeal2015-004051
Application 12/920,345
D. The Examiner rejected claims 21, 23-31, 33, and 35 under 35 U.S.C.
§ 103(a) as obvious over Rehmani4 and Turner5 (Final Act. 8-10).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds that with respect to claim 27 "it is unclear how
C14H1sN4Q3· ZnSQ4 and C14H1sN4Q3· Zn014H22C12 represent a zinc salt when
the formula comprises both trimethoprim and a zinc salt. Instead it seems to
more clearly represent a salt of the admixture as opposed to just zinc" (Final
Act. 4; Ans. 4).
Appellant responds "the formula represents a zinc acetate/zinc
gluconate salt" (App. Br. 12).
We find that the Examiner has the better position. While one of the
molecules listed in claim 27 appears to be a zinc acetate/zinc gluconate salt,
the other two molecules appear to be complexes of trimethoprim and a zinc
salt, not zinc salts alone. If the C14H1sN4Q3 portion represents trimethoprim
and the ZnSQ4 or Zn014H22C12 portions represent sulphate or digluconate
salts of zinc, then we agree with the Examiner that it is indefinite if these
two compounds in claim 2 7 are intended to represent a zinc
salt/trimethoprim complex of some sort or if these two compounds are
simply intended to exemplify the zinc sulfate and zinc digluconate salts.
Appellant provides no clear explanation rebutting the Examiner's position.
4 Rehmani et al., Coordination of Septran Drug with Trace Metal Ions in the
Biological System, 3 INT. J. BIOLOGY AND BIOTECHNOLOGY 439--442 (2006).
5 Turner et al., Effect of Treatment with Zinc Gluconate or Zinc Acetate on
Experimental and Natural Colds, 31 CLINICAL INFECTIOUS DISEASES 1202-
1208 (2000)
3
Appeal2015-004051
Application 12/920,345
B. 35 U.S.C. § 112,fourthparagraph
The Examiner finds that:
Claim 23 recites "wherein the composition comprises between
about 0.1 mg and 200 mg of zinc and between about 50 mg and
about 1000 mg trimethoprim." This does not further limit claim
21 which recites that the ratio of zinc to trimethoprim is
between about 1:3 and about 1:7. If only 0.1 mg zinc and 50
mg of trimethoprim were present, using the lower ends of both
ranges, the ratio would be 1:500. This falls outside of the ratio
of claim 21 and thus does not further limit the claim.
(Final Act. 6).
Appellant contends that "these ranges all fall within the scope of
claim 21" (App. Br. 15).
We find for Appellant because the claims are reasonably construed as
further limiting. Claim 21 establishes a ratio of zinc and trimethoprim, but
provides no specific dosing amounts. Claim 23 limits claim 21 by limiting
the amounts of zinc to 0.1 mg to 200 mg and the amounts of trimethoprim to
50 mg to 1000 mg. For example, there cannot 300 mg of zinc or 5 mg of
trimethoprim within the scope of claim 23, while claim 21 could encompass
such values. The Examiner is correct that particular points could be selected
for zinc and trimethoprim within the ranges of claim 23 that would fall
outside the ratio required by claim 21. However, these selections would not
fall within the scope of the claims because claim 23 is dependent upon claim
21. Therefore, any selection of zinc to trimethoprim values that fall outside
the ratio of claim 21 does not fall within the scope of these claims.
4
Appeal2015-004051
Application 12/920,345
C. 35 U.S. C. § 102(b) over Simo
The Examiner finds that Simo teaches
synthesis of zinc salt complexed with trimethoprim. For
example zinc chloride was complexed with trimethoprim
wherein 0.07 g of ZnCh was combined with 0.29 g of
trimethoprim. In addition, zinc acetate (0.11 g) was combined
with trimethoprim (0.29g). See page 276, Synthesis of
Complexes. These limitations meet the weight ratio of from 1 :3
to 1:7 of zinc to trimethoprim and 0.1 to 200 mg zinc and 50 to
1000 mg trimethoprim.
(Final Act. 7).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Simo teaches a composition
where the weight ratio of "zinc to the trimethoprim is from about 1 :3 to
about 1 : 7" as required by claim 21?
Findings of Fact
1. The Specification teaches, in Example 2, that
A trimethoprim and zinc sulfate mixture was administered to all
16 subjects. They all reported recovery full to partial within 48
hours ... The zinc/trimethoprim compositions (Tri-Z)
administered were in the following dosage range: 0.18 mg of
zinc to 1 mg of Trimethoprim for 25 dosages of 100 mg (82 mg
Trimethoprim and 18 mg Zinc) to dosages of 400 mg (328 mg
Trimethoprim and 72 mg zinc) once or twice daily for up to 5
days.
(Spec. 23:19-27).
2. Simo teaches:
Synthesis of [Zn(Trim)2Ch] (2). The complex was prepared as
follows: A methanolic solution of ZnCh (0.50 mmol, 0.07 g)
5
Appeal2015-004051
Application 12/920,345
was added to a methanolic solution of trimethoprim ( 1 mmol,
0.29 g). The final volume was 100 ml. By slow evaporation of
the obtained solution at room temperature, almost colorless
crystals suitable for X-ray structure determination were formed
after 5 days.
(Simo 276, col. 1 ).
3. Simo teaches: "Synthesis of Zn(Trim)(CH3CQ0)2 (3). A
methanol solution of Zn(CH3CQ0)2· 2H20 (0.50 mmol, 0.11 g) was added to
a methanolic solution of trimethoprim (1 mmol, 0.29 g) with continuous
stirring. The final volume was 100 ml. A colorless microcrystalline
compound was obtained after 3--4 days" (Simo 276, col. 1).
4. Appellants acknowledge that the "weight ratio of ZnCb to
trimethoprim in Simo is 0.07 g:0.29g and thus 1 :4.14" (App. Br. 17).
5. The Appellants' Appendix analysis of Simo is reproduced
below:
i Zn Comp Mass r .. . . . . ...... .
Simo mol.wt. Zn mol.wt. !Ratio of zim: j {g) Zinc Mass Trirn9thoprim Mass iRatio Znifri(1i'x}.
Zn:"A-::12 183.48 85.38~2 li:~;:i;:·1U:)1r, ~1,.r ........ v .... ~"t"· '<,/ !0.1 1 o. 03s~1: ·97 842 0.29
r .. :· .. : .. ·.:. ·. ·.· · .. : ·.
~:rag:sae6523:-:=
65 . .3S~? In ···o~src~~2 r .. ·~~ ........ ·Ji·:..·:.. jo.·1 ·~ 0.0327-85467 0.29 h•s~F1~·i83§ • ,,,,, ............ .t ~~ • ,., .
S5,3E;2 l OA 7963SO 71 jG.07 O. OJJ5.f 4 735· 0,29 ~~ ~"'4''"1 +" !l}J~,;r >,;' 1'4
.
The Appendix shows that in the zinc acetate/trimethoprim composition the
ratio of elemental zinc to trimethoprim is 7. 3 9 8.
Principles of Law
Anticipation under 35 U.S.C. § 102 requires that "each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference." In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999).
6
>:
Appeal2015-004051
Application 12/920,345
"An essential purpose of patent examination is to fashion claims that
are precise, clear, correct, and unambiguous. Only in this way can
uncertainties of claim scope be removed, as much as possible, during the
administrative process." In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
Analysis
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The specific term
at issue in claim 21 is "zinc".
Appellant interprets the term "zinc" as limited to elemental zinc (see
App. Br. 17), while the Examiner finds that "neither the claims nor the
specification clearly state that the ratio refers to elemental zinc as opposed to
the zinc compound" (Ans. 6).
As we interpret the term "zinc" in light of the Specification, and
Example 2 in particular, we find that the Examiner has the better position.
Example 2 of the Specification teaches a "trimethoprim and zinc sulfate
mixture was administered" but then further references to this mixture are to
"zinc/trimethoprim compositions" (FF 1 ). Thus, the Specification is
reasonably interpreted as using the term "zinc" to encompass "zinc sulfate"
(FF 1 ). Therefore, the broadest reasonable interpretation of the term "zinc"
in claim 21 is that the term "zinc" encompasses zinc salts such as zinc
sulfate. Appellants did not choose to amend claim 21 by referring to a ratio
using only elemental zinc or some other limiting phrase.
Therefore, as acknowledged by Appellant, Simo teaches a
composition comprising a "weight ratio of Zn Cb to trimethoprim in Simo is
0.07g:0.29g and thus 1:4.14" (FF 2 and 4), and anticipates the composition
7
Appeal2015-004051
Application 12/920,345
of claim 21. The "antiviral" preamble limitation is not limiting because
claim 21 defines "a structurally complete invention in the claim body and
uses the preamble only to state a purpose or intended use for the invention."'
Catalina Mktg. Int'!, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed.
Cir. 2002).
Even if the term "zinc" were interpreted as limited to elemental zinc,
Simo still reasonably anticipates claim 21. As Appellant's own Appendix
shows, Simo teaches that in the zinc acetate/trimethoprim composition the
ratio of elemental zinc to trimethoprim is 7 .398 (FF 3, 5). Because claim 21
uses the phrase "about 1 :7" when referring to zinc/trimethoprim ratios, the
upper bound of the ratio claimed does not end precisely at 1 :7. The
"[a]pplication's use of the term 'about' shows that the applicants did not
intend to limit the claimed ranges to their exact end-points." In re Harris,
409 F.3d 1339, 1343 (Fed. Cir. 2005). Here, the 1:7.398 ratio in the zinc
acetate/trimethoprim composition of Simo is reasonably interpreted as
anticipating the "about 1 :7" ratio of claim 21 and Appellants did not delete
the term "about" from claim 21. The Federal Circuit has explained that it is
"during patent prosecution when claims can be amended, ambiguities should
be recognized, scope and breadth of language explored, and clarification
imposed." Zletz, 893 F.2d at 321.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that Simo
teaches a composition where the weight ratio of "zinc to the trimethoprim is
from about 1 :3 to about 1 :7" as required by claim 21.
8
Appeal2015-004051
Application 12/920,345
D. 35 U.S.C. § 103(a) over Rehmani and Turner
The Examiner finds that Rehmani teaches "a composition comprising
trimethoprim and zinc. The composition is effective against viruses" (Ans.
8). The Examiner finds that Turner teaches "lozenges comprising 5 mg or
11. 5 mg of zinc acetate or lozenges comprising 13 .3 mg of zinc gluconate to
treat rhinovirus cold" (Ans. 9).
The Examiner finds that "the determination of suitable ranges,
percentages or ratios can be obtained through routine or manipulative
experimentation." (Id.). The Examiner concludes that
formulations and modifications of amount of active
ingredient are well within the purview of the skilled
artisan to optimize in order to provide a composition
with greater efficacy, bioavailability, and compliance
as evidenced by Roxas et al. which teach various
dosages of zinc as sulfate, gluconate, and acetate salts
in lozenge and syrup form.
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Rehmani and Turner render a
composition with the zinc/trimethoprim ratios required by claim 21 obvious?
Findings of Fact
6. Rehmani teaches "[s]eptran is a sulphonamide combination
drug containing trimethoprim and sulpha methaoxazole" (Rehmani 439).
7. Rehmani teaches that"[ o ]ver 3300 sulphonamides have been
prepared ... They are effective against gram-positive bacteria ... and virus"
(Rehmani 439).
9
Appeal2015-004051
Application 12/920,345
8. Rehmani teaches "complex formation of sulpfamethoxazole
[sic] and trimethoprim with trace metal ions such as ... Zn(II)" (Rehmani
439).
9. Rehmani teaches that "[a]ll the titration[s] were done at room
temperature, 20 ml of0.01 M metal ion solution mixed with 20ml of 0.01 M
septran drug solution and titrated with O.OlM NaOH solution" (Rehmani
440).
10. Turner teaches that "[z]inc compounds appear to have little
utility for common-cold treatment" (Turner 1202, Abstract).
11. Turner teaches "in these studies zinc gluconate had a modest
and inconsistent effect on common-cold symptoms, and zinc acetate had no
beneficial effect" (Turner 1207, col. 1 ).
Principles of Law
As stated in Antonie, while discovery of an optimum value of a
variable is normally obvious, one exception to this rule is the situation where
the parameter optimized was not recognized to be a result-effective variable.
See In re Antonie, 559 F.2d 618, 620 (CCPA 1977).
Analysis
Appellant contends that while "it may be possible to calculate by
weight an amount of zinc used in the methods of Rehmani it is not possible
to calculate an amount of trimethoprim in weight as the only information
provided is a molarity of Septran, a combination of two drugs, and not a
molarity of trimethoprim" (App. Br. 25). Appellant, nevertheless, contends
that in Rehmani' s solutions "the ratio of zinc to trimethoprim is 5: 1, which
falls outside the ratio in applicant's amended claims" (App. Br. 24).
10
Appeal2015-004051
Application 12/920,345
Appellant contends that "[ t ]here is nothing in the reference of
Rehmani that indicates, suggests, or hints that one should use zinc and
trimethoprim (in the form of Septran or in any other form) together for
anything" (App. Br. 24). Appellant contends that "there is no teaching in
Rehmani of any anti-viral activity for trimethoprim" (App. Br. 31 ).
The Examiner responds that "the claims are directed to a composition,
not method of treating. Therefore Rehmani does not need to specifically
teach a method of treating viral infections as argued by the appellant" (Ans.
8).
We find that Appellant has the better position. The Examiner's reason
for combining trimethoprim and zinc is, essentially, a Kerkhoven rationale to
combine two known elements for the benefits of each element separately.
See In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) ("It is prima facie
obvious to combine two compositions each of which is taught by the prior
art to be useful for the same purpose, in order to form a third composition
which is to be used for the very same purpose.")
However, as Appellant correctly notes, there is no evidence that
trimethoprim has antiviral activity, and consequently even if zinc gluconate
is useful as an antiviral, there would have been no reason to combine zinc
gluconate with trimethoprim because the two drugs are not useful for the
same purpose.
If the Examiner is, instead, relying upon the obviousness of
combining the entire trimethoprim and sulpha methaoxazole composition
known as Septran with zinc gluconate, because the sulpha methaoxazole
component allegedly might have antiviral activity (FF 7), then there would
11
Appeal2015-004051
Application 12/920,345
have been no reason to optimize the ratio of trimethoprim to zinc, because
that ratio would not have been recognized as a results optimizable variable
in anti-viral activity. Antonie, 559 F.2d at 620.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Rehmani and Turner render a composition with the zinc/trimethoprim
ratios required by claim 21 obvious.
SUMMARY
In summary, we affirm the rejection of claims 27, 30, 31, 33, and 35
under 35 U.S.C. § 112, second paragraph as indefinite.
We reverse the rejection of claims 23, 31, 33, and 35 under 35 U.S.C.
§ 112, fourth paragraph.
We affirm the rejection of claim 21under35 U.S.C. § 102(b) as
anticipated by Simo. Claims 23-31, 33, and 35 fall with claim 21.
We reverse the rejection of claims 21, 23-31, 33, and 35 under 35
U.S.C. § 103(a) as obvious over Rehmani and Turner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
12