Ex Parte Shields et al

Patent Trial and Appeal Board

Oct 30, 2017

14402977 (P.T.A.B. Oct. 30, 2017)

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.
14/402,977 11/21/2014 Shelly Lynn Shields PC71928A 2060
110408 7590
Zoetis
10 Sylvan Way
Parsippany, NJ 07054
EXAMINER
OGUNBIYI, OLUWATOSIN A
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
11/01/2017 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):
AnimalHealthDocketing @ zoetis .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHELLY LYNN SHIELDS and
OMAR YOUSIF ABDELMAGID1
Appeal 2017-000052
Application 14/402,977
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a bacterial disease in a dog caused by Bordetella bronchiseptica,
which have been rejected as anticipated, and provisionally rejected for
nonstatutory double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We have jurisdiction under 35 U.S.C. § 6(b). We affirm and enter
New Grounds of Rejection.
1 Appellants identify the Real Party in Interest as Zoetis Services LLC.
(App. Br. 3.)
Appeal 2017-000052
Application 14/402,977
STATEMENT OF THE CASE
Appellants’ invention “relates to compositions comprising Canine
Respiratory Coronavirus (CRCoV) preparation for treatment or prevention
of multi-factorial diseases, particularly comprising bacterial infections, in a
dog.” (Spec. 1:7-9.)
As background, the Specification explains, “[d]ogs infected with
multiple respiratory pathogens, particularly both viral and bacterial
pathogens, may contract canine infectious respiratory disease complex
(CIRDC), which is a highly contagious multifactorial disease common in
dogs housed in crowded conditions, such as re-homing centers and boarding
or training kennels.” {Id. at 1:19—22.) The Specification further explains
that “[rjespiratory pathogens seen in dogs infected with CIRD include the
bacterium Bordetella bronchiseptica . . . [and] canine respiratory
coronavirus (CRCoV),” among others. {Id. at 1:23—29.)
Claims 1,3, and 7—9 are on appeal. Claim 1 is illustrative:
1. A method of treating a bacterial disease in a dog caused by
Bordetella bronchiseptica, comprising administering to the dog
a composition comprising an antigenic component, the
antigenic component consisting of canine respiratory
coronavirus (CRCoV) and one or more of canine parainfluenza
virus (CPIV), canine adenovirus-2 (CAV-2), canine influenza
virus (CIV), canine distemper virus (CDV), canine parvovirus
(CPV), enteric canine coronavirus (CCV), canine adenovirus,
Leptospira canicola, Leptospira grippotyphosa, Leptospira
icterohaemorrhagiae, Leptospira pomona, Leptospira
bratislava, canine herpesvirus, canine pneumovirus, Leishmania
organisms, a Borrelia species, Mycoplasma species, rabies, and
Ehrlichia canis.
(App. Br. 12 (Claims App.) (emphasis added).)
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Application 14/402,977
The claims stand rejected as follows:
I. Claims 1, 3, and 7—9 under 35 U.S.C. § 102(b) by Tucker.2
II. Claims 1, 3, and 7—9 under 35 U.S.C. § 102(e) by Abdelmagid
’8213 or Abdelmagid ’369.4 Abdelmagid ’821 and Abdelmagid
’369 are the respective PCT and U.S. publications of patent
application PCT/IB2012/050512. Given the overlapping
disclosures, we focus in this Decision on Abdelmagid ’369.
III. Claims 1, 3, and 7—9 under 35 U.S.C. § 102(e) by Abdelmagid
’8205 or Abdelmagid ’733.6 Abdelmagid ’820 and Abdelmagid
’733 are the respective PCT and U.S. publications of patent
application PCT/IB2012/050510. Given the overlapping
disclosures, we focus in this Decision on Abdelmagid ’733.
IV. Claims 1,3, and 7—9 are provisionally rejected for nonstatutory
double patenting over claims 1—20 of co-pending U.S.
Application No. 13/983,127 (“the ’127 Application”).
REJECTIONS I—III
Issue
We address the anticipation rejections together. The Examiner
rejected claims 1,3, and 7—9 as anticipated by Tucker (Rejection I),
Abdelmagid ’369 (Rejection II), or Abdelmagid ’733 (Rejection III).
2 Tucker et al., US 2010/0028379 Al, published Feb. 4, 2010.
3 Abdelmagid et al., WO 2012/104821 Al, published Aug. 9, 2012.
4 Abdelmagid et al., US 2013/0302369 Al, published Nov. 14, 2013.
5 Abdelmagid et al., WO 2012/104820 Al, published Aug. 9, 2012.
6 Abdelmagid et al., US 2014/0079733 Al, published Mar. 20, 2014.
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Application 14/402,977
The Examiner finds Tucker teaches “administering to [a] dog
therapeutically effective amounts of a vaccine comprising viral antigens and
bacterial antigens wherein the vaccine comprise[s] canine respiratory
coronavirus, Bordetella bronchiseptica, canine parvovirus,” and other
antigens along with “a pharmaceutically acceptable carrier.” (Ans. 2—3
(citing Tucker Abstract and Tflf 5, 6, 7, 45 and 50).)
The Examiner finds Abdelmagid ’369 “disclose[s] a method of
treating or preventing canine infectious respiratory disease complex
(CIRDC[)] in a canine by administering to the canine a vaccine composition
comprising Bordetella bronchiseptica and further comprising canine
respiratory coronavirus (CRoV),” along with other antigens and a
pharmaceutically acceptable carrier. {Id. at 3^4 (citing Abdelmagid ’369
claims 1—20).)
The Examiner finds Abdelmagid ’733 also anticipates Appellants’
invention because it teaches “treating or preventing canine infectious
respiratory disease complex (CIRDC[)] in a canine by administering to the
canine including a dog a vaccine composition comprising Bordetella
bronchiseptica and further comprising canine respiratory coronavirus
(CRoV), canine parainfluenza virus (CPIV),” along with other antigens as
well as a pharmaceutically acceptable carrier. {Id. at 4—5.) According to the
Examiner, Abdelmagid ’733 further teaches the method “treat[s] bacterial
disease in a dog caused by B. bronchiseptica . . . and protects] against a
multifactorial canine respiratory disease,” and “will also have a duration of
efficacy against the bacterial disease for a period of at least 6 months.” {Id.
at 5 (citing Abdelmagid ’733 Tflf 1—14, 33, and claims 1—20).)
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Application 14/402,977
Appellants argue the Examiner misinterpreted claim 1 as not
excluding a B. bronchiseptica antigen. (App. Br. 7—8.) According to
Appellants, in using the transitional phrase “consisting of,” “[t]he claim
recites the closed-claiming language with regard to the antigenic
component.” (Id. at 8.) Appellants contend the definition of “antigen”
provided in the Specification encompasses B. bronchiseptica (or a part
thereof), yet “B bronchiseptica antigens are not recited within the antigenic
component” of claim 1. (App. Br. 7—8 (citing Spec. 5:17—29).)
Properly interpreted, Appellants argue, the claims are not anticipated
because “all references cited by the Examiner disclose methods of protecting
a dog from B bronchiseptica infection by administering the dog a
composition comprising a B bronchiseptica antigen.” (Id. at 6.)
The issue on appeal is whether a preponderance of the evidence
supports the Examiner’s finding that Tucker, Abdelmagid ’369, or
Abdelmagid ’733 disclose the claimed subject matter.
Findings of Fact (FF)
FF 1. Tucker teaches “a method of treating a dog for canine diseases
comprising administering to the dog therapeutically effective amounts of a
vaccine, wherein the vaccine comprises viral antigens, a bacterin, or both.”
(Tucker Abstract.) Tucker teaches:
The viral antigens comprise one or more of 1) canine distemper
(CD) virus, 2) canine adenovirus type 2 (CAV-2), 3) canine
parainfluenza (CPI) virus, 4) canine parvovirus (CPV), 5) and
canine coronavirus (CCV), and wherein the bacterin comprises
one or more of Leptospira canicola . . . L. bratislava, and
Bordetella bronchiseptica', and any combination of viral antigens
and bacterin thereof.
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Application 14/402,977
(Tucker | 5 ; see also id. 11 6-7.)
FF 2. Tucker teaches, “[i]n one embodiment, the viral antigens are
CD virus, CAV-2, CPI virus, and CPV. ... In still another embodiment,
these four viral antigens are combined with the CCV antigen and a bacterin
composed of Leptospira canicola, L. grippotyphosa, L.
icterohaemorrhagiae, and L. pomona” (Id. | 8; see also id. at claim 5.)
FF 3. Tucker teaches “[t]he treated canine diseases comprise one or
more of the following: 1) CD caused by CD virus . . . ; 3) respiratory disease
caused by CAV-2 or respiratory CCV . . . ; and 7) infectious
tracheobronchitis (‘kennel cough’) caused by Bordetella bronchiseptica.”
(Id. 19; see also id. 145 and claim 7.)
FF 4. Tucker teaches therapeutically effective amounts for live
viruses and attenuated viruses, and the bacterins. (Id. 46, 47.) Tucker
further teaches the vaccines may include pharmaceutically acceptable
vehicles, excipients, etc. (Id. 150.)
FF 5. Abdelmagid ’733 teaches compositions “against canine
respiratory diseases, including canine infectious respiratory disease complex
(CIRDC).” (Abdelmagid ’733 11; see also id. 2—14.) Abdelmagid ’733
teaches “[t]he pathogenesis of CIRDC is considered to be multifactorial,
involving several viruses and bacteria. Infectious agents known to be
causative agents of CIRDC include canine respiratory coronavirus
(CRCoV)[,] . . . CIV[,] . . . and the bacterium Bordetella bronchiseptica.”
(Id. 13.)
FF 6. Abdelmagid ’733 teaches “[i]n one embodiment, an
immunogenic composition comprises a canine influenza virus (CIV) and a
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Application 14/402,977
canine respiratory coronavirus (CRCoV). In another embodiment, the
immunogenic composition further comprises a Bordetella bronchiseptica.”
{Id. 112; see also id. at claims 1, 13, and 14 (administering a composition
comprising CIV and CRCoV to treat or prevent CIRDC in canines).)
FF 7. Abdelmagid ’733 teaches the compositions prevent CIRDC for
a period of six months or more. {Id. 120 and claim 14.)
Analysis
Claims 1,3, and 7—9 have not been argued separately. We select
claim 1 as representative. 37 C.F.R. § 41.37(c)(l)(iv).
We start with claim construction. At issue is the phrase “the antigenic
component consisting of,” as recited in claim 1. More specifically, whether
the claim is limited to the antigens that follow the phrase and those antigens
alone — “canine respiratory coronavirus (CRCoV) and one or more of
canine parainfluenza virus, canine adenovirus-2 (CAV-2),” etc. Or, as
asserted by the Examiner, whether the phrase “comprising” earlier in claim 1
should be construed as opening the claim to other antigenic components
such as B. bronchiseptica.
We agree with Appellants that claim 1 is closed and excludes un­
recited antigenic components. “Use of the transitional phrase ‘consisting of
to set off a patent claim element creates a very strong presumption that that
claim element is ‘closed’ and therefore ‘exclude[s] any elements, steps, or
ingredients not specified in the claim.’” Multilayer Stretch Cling Film
Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016)
(citing AFG Indus., Inc. v. CardinalIG Co., Inc., 239 F.3d 1239, 1245 (Fed.
Cir. 2001).) As described and defined in the Specification, B.
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Application 14/402,977
bronchiseptica is an antigen. (See, e.g., Spec. 5:17—29 and 6:1—3.) And,
because it is not among the list of antigens following the claim phrase “the
antigenic component consisting of,” it is excluded from claim 1.
The Examiner is correct that the term “comprising” appearing
elsewhere in claim 1 leaves the claim open. (Ans. 9—10.) But the claim is
open only to other elements that are not encompassed by Appellants’
definition of antigen (e.g., diluents like water or saline.) Even if the
Specification describes “adjuvants” as potentially including other antigens,
which the Examiner points out (Ans. 10), any adjuvant used with the method
and composition in claim 1 cannot include un-recited antigenic components
— otherwise the composition falls outside the scope of the claim.7
Although we disagree with the Examiner’s claim interpretation, the
analysis does not end. Tucker (Rejection I) teaches administering to dogs
vaccines that include the antigenic components in claim 1, without the
excluded antigens like B. bronchiseptica. Tucker, for example, discloses an
embodiment of a vaccine including viral antigens that are canine
coronavirus,8 canine distemper virus, canine adenovirus type 2, canine
7 The Examiner cites In re Crish, 393 F.3d 1253 (Fed. Cir. 2004) in support
of the Examiner’s claim interpretation. (Ans. 11—12.) That decision is
inapplicable to the claims here as argued by Appellants. (Reply Br. 8—9.)
8 Different forms of coronavirus can cause respiratory and enteric disease in
dogs (Spec. 13:23—28), but we find the skilled person would interpret
Tucker’s disclosure as including antigens of canine respiratory coronavirus
as Tucker expressly teaches treating respiratory disease caused by
respiratory CCV. (FF 3.) The Examiner also found, and Appellants did not
dispute, that Tucker teaches administering vaccines comprising canine
respiratory coronavirus. (Ans. 2—3.)
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Application 14/402,977
parainfluenza vims, and canine parvovims, along with four bacterins. (FF
1—2.) The viral antigens and bacterins in this embodiment are all present in
claim 1. And B. bronchiseptica is not included. Tucker also teaches the
vaccines may include “one or more” of five viral antigens and “one or more”
of six bacterins, and “any combination” of those antigens and bacterins. (FF
1.) The only one of these eleven antigenic components excluded from claim
1 is B. bronchiseptica. Based on these disclosures in Tucker, we find that
combinations with the claimed antigenic components (and excluding B.
bronchiseptica) are expressly taught, or would be immediately apparent to
the skilled artisan. Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683
F.3d 1356, 1361 (Fed. Cir. 2012); In re Petering, 301 F.2d 676, 681-82
(CCPA 1962) (holding a disclosure that allows a skilled artisan to “at once
envisage each member of [a] limited class” can anticipate).
Tucker teaches treating tracheobronchitis caused by Bordetella
bronchiseptica, but does not explicitly disclose doing so with compositions
that lack B. bronchiseptica. (FF 3.) Absent persuasive evidence to the
contrary, however, we find that treating9 a bacterial disease caused by
Bordetella bronchiseptica, as recited in claim 1, is an inherent byproduct of
administering to dogs Tucker’s compositions, such as the one having nine-
antigenic components described in the preceding paragraph. (FF 2-A.) In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (“It is a general mle that
merely discovering and claiming a new benefit of an old process cannot
render the process again patentable.”) That a composition comprising at
9 As defined in the Specification, “treating” includes, inter alia, inhibiting or
protecting against the disease. (Spec. 12:23—29.)
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Application 14/402,977
least canine respiratory coronavirus and canine influenza virus, with no B.
bronchiseptica, would provide the “treating” as claimed is further evidenced
by Abdelmagid ’733. Abdelmagid ’733 (discussed further below) discloses
that (i) CIRDC is a multifactorial disease caused, in part, by Bordetella
bronchiseptica, and (ii) that CIRDC may be treated or prevented with
compositions comprising canine influenza virus and canine respiratory
coronavirus. (FF 5—7.)
Like Tucker, Abdelmagid ’733 (Rejection III) does not require
Bordetella bronchiseptica in its immunogenic compositions. To the
contrary, Abdelmagid ’733 teaches CRCoV-containing vaccines with and
without additional antigens. (FF 5—7; see also Abdelmagid ’733 ]Hf 133—
154.) Abdelmagid ’733 describes an embodiment comprising CIV and
CRCoV, and teaches “[i]n another embodiment, the immunogenic
composition further comprises a Bordetella bronchiseptica.'1'’ {Id. 112
(emphasis added); FF 5—6.) In other words, B. bronchiseptica is required in
only some embodiments. And Abdelmagid ’733 teaches that immunogenic
compositions with CRCoV and CIV, and without B. bronchiseptica, are
suitable for treating CIRDC. (FF 5—6.) As discussed above, Bordetella
bronchiseptica is a known causative agent for CIRDC. (FF 5.) Thus, we
find unpersuasive Appellants’ contention that Abdelmagid ’733 requires
compositions containing B. bronchiseptica antigen for treating diseases
caused by Bordetella bronchiseptica. (App. Br. 10.)
For the reasons above, we affirm the Examiner’s rejection of claim 1
as anticipated by Tucker or Abdelmagid ’733 (and the PCT counterpart
Abdelmagid ’820 reference). Dependent claims 3 and 7—9 fall with claim 1.
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Application 14/402,977
Nevertheless, because we disagree with the Examiner’s claim interpretation,
and because our findings and explanation expand upon and/or differ from
the Examiner’s in some ways, we designate our affirmance as New Grounds
of Rejection, giving Appellants a fair opportunity to respond in prosecution.
With respect to Rejection II, the Examiner cited no supporting
disclosures in Abdelmagid ’821 and only cited claims 1—20 from the related
Abdelmagid ’369 reference. (Ans. 3—4.)10 Claims 1—20 of Abdelmagid
’369 all require compositions including either Bordetella bronchiseptica or
recombinant p68 pertactin antigens. (Abdelmagid ’369 claims 1 and 14.)
Those antigens are not recited in, and so are excluded from, claim 1 and
dependent claims 3 and 7—9 for the reasons explained above. We thus
reverse the Examiner’s rejection of claims 1,3, and 7—9 over Abdelmagid
’821 and Abdelmagid ’369.
REJECTION IV
The Examiner provisionally rejected claims 1,3, and 7—9 over claims
1—20 of the ’127 Application for nonstatutory double patenting. (Ans. 5—6.)
The cited claims of the ’127 Application all require a composition
comprising Bordetella bronchiseptica and/or an isolated pertactin antigen, or
a method of administering a composition including those antigens. (See
Claims mailed Nov. 2, 2015 and Claims mailed June 29, 2017.) For the
10 We decline to decide in this appeal whether the claims are anticipated (or
obvious) based on disclosures in Abdelmagid ’821 and/or Abdelmagid ’369
that were not cited to us by the Examiner. The exercise of authority under
37 C.F.R. § 41.50(b) is discretionary, and no inference should be drawn
from the decision to exercise that discretion with respect to only some of the
references on appeal.
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Application 14/402,977
reasons discussed above, the antigens recited in the claims of the ’127
Application are excluded from the scope of the claims on appeal here. The
Examiner’s double patenting rejection is, thus, unpersuasive and is reversed.
NEW GROUND OF REJECTION UNDER 35 U.S.C § 112,14
We enter a further New Ground of Rejection of claim 7 for being in
improper dependent form. Claim 1 requires CRCoV and at least one
additional antigenic component. Claim 7 purports to include CRCoV as the
only antigenic component and, thus, does not include all the elements of
claim 1, from which claim 7 depends.
SUMMARY
We affirm the rejection of claims 1,3, and 7—9 as anticipated by
Tucker (Rejection I), or by Abdelmagid ’820 or Abdelmagid ’733 (Rejection
III), but we designate the affirmances as New Grounds of Rejection. We
reverse the rejection of claims 1,3, and 7—9 as anticipated by Abdelmagid
’821 or Abdelmagid ’369 (Rejection II). We reverse the provisional
nonstatutory double patenting rejection (Rejection IV). We also enter a New
Ground of Rejection of claim 7 under 35 U.S.C. § 112, fourth paragraph
(pre-AIA).
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 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
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Application 14/402,977
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
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 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 (9th
Ed, Rev. 07.2015, Nov. 2015).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED: 37 C.F.R, § 41.50(b)
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