Ex Parte Seeberger et al

Patent Trials and Appeals Board

Apr 15, 2019

14385948 - (D) (P.T.A.B. Apr. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/385,948 09/17/2014
62008 7590 04/17/2019
MAIER & MAIER, PLLC
345 South Patrick Street
ALEXANDRIA, VA 22314
FIRST NAMED INVENTOR
Peter H. Seeberger
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.
05390003US 1022
EXAMINER
KRISHNAN, GANAPATHY
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
04/17/2019 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):
patent@maierandmaier.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER H. SEEBERGER, PIERRE ST ALLFOR TH,
GENNARO DE LIBERO, and MARCO CA V ALLARI
Appeal2018-007787
Application 14/385,948
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
VALEK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to carbohydrate-glycolipid conjugates. The Examiner rejected the
claims as obvious and for obviousness-type double patenting ("ODP"). We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
Claims 32, 36, 41, 42, 44--49, 51, and 55 are on appeal, and can be
1 Herein we refer to the Declaration under 37 C.F.R. § 1.132 of Peter H.
Seeberger, Ph.D. dated January 23, 2017 ("Seeberger Deel."), Final Office
Action mailed September 21, 201 7 ("Final Act."), Appeal Brief filed
February 21, 2018 ("App. Br."), Examiner's Answer mailed May 17, 2018
("Ans."), and Reply Brief filed July 17, 2018 ("Reply").
Appeal2018-007787
Application 14/385,948
found in the Claims Appendix of the Appeal Brief. Claim 32 is the only
independent claim and is directed to a compound of general formula (XIV).
The portion of claim 32 depicting that formula is copied below.
32. Compound of the general fori:Ht.da (XIV).
(XIV)
App. Br. 17. As shown above, Formula (XIV) requires an a-galactosyl
ceramide moiety (a-GalCer) conjugated through a linker (L) to a
carbohydrate antigen (A) at the C6-position of the sugar ring. See App. Br.
17.
Appellants seek review of the following grounds of rejection made by
Examiner:
I. Claims 32, 36, 41, 42, 44--49, 51, and 55 under 35 U.S.C.
§ 103(a) as obvious over Leadbetter, 2 Leadbetter II, 3 and
Cadeddu. 4
II. Claims 32, 36, 49, and 51 for ODP over claim 1 ofHacohen et
al., (US 8,273,357 B2 ("Hacohen").
2 Elizabeth Leadbetter et al., WO 2007/051004 A2, published May 3, 2007
("Leadbetter").
3 Elizabeth Leadbetter et al., NK T Cells Provide Lipid Antigen-Specific
Cognate Help For B Cells, PNAS, Vol. 105, 8339-8344 (2008) ("Leadbetter
II").
4 Aline Banchet-Cadeddu et al., The Stimulating Adventure of KRN 7000,
Org. Biomol. Chem., Vol. 9, 3080-3104 (2011) ("Cadeddu").
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Application 14/385,948
App. Br. 3. Appellants do not argue the dependent claim separately from
claim 32 for either rejection so those claims stand or fall with claim 32. 37
C.F.R. § 41.37 (c)(l)(iv).
Findings of Fact
FF 1. Leadbetter teaches antigen conjugates of the formula shown below.
Leadbetter 3--4. Leadbetter teaches that R1 and R4 are H, R2 is a hydroxyl
substituted alkyl chain, and R3 is OH in the above formula, which corresponds
to a-GalCer. Id. at 4.
FF2. Leadbetter teaches that "[c]onjugation may occur at any carbon in the
sugar ring of Formula I shown above and may involve either the direct
binding of the antigen or attachment of antigen via a linker." Leadbetter 4.
Formula II of Leadbetter shows this conjugation at C2 of the sugar ring. Id.
Leadbetter further teaches that the antigen may be bonded "via the 2' -, 4' -,
or 6'-position of the ring." Id. at 13.
FF3. Leadbetter teaches that the antigens for its conjugates include
"polysaccharides such as glycans." Leadbetter 19. Leadbetter explains that
these "antigens may be derived from bacteria, mycobacteria, viruses, fungi
and parasites." Id. at 21-26 (listing antigen sources).
FF4. Leadbetter teaches exemplary reaction pathways for "the synthesis of
antigen conjugates" in Figures 2 and 3. Leadbetter 9, Fig. 2-3.
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Application 14/385,948
FF5. Leadbetter II teaches procedures for the synthesis ofNP-a-GalCer,
i.e., the hapen, 4-hydroxy-3-nitrophenyl (NP), conjugated to a-GalCer.
Leadbetter II 8339, 8343--44.
Analysis
Obviousness Rejection of Claims 32, 36, 41, 42, 44--49, 51, and 55
Examiner finds that Leadbetter discloses a-GalCer residues
conjugated to a carbohydrate antigen as recited in claim 32. Final Act. 4.
While Leadbetter "does not exemplify a conjugate that is attached to the
sugar ring via a linker through the oxygen of the sugar ring at the 6-
position," Examiner determines that Leadbetter teaches that the antigen may
also be conjugated at the C6 position "and still produce a strong immune
response." Id. at 4--5. Examiner further finds that the cited references teach
procedures for making such conjugates and that "Leadbetter is an enabling
reference." Id. 6-7.
Appellants contend that "a skilled artisan would not have been able to
conjugate a bacterial polysaccharide or oligiosaccharide antigen as listed on
page 4 of the Leadbetter reference to the glycosphigolipid a-
galacosylceramide (a-GalCer)." App. Br. 9. In addition, Appellants argue
that Leadbetter and Leadbetter II "only provide a single example of a lipid
antigen conjugate (NP-a-GalCer), wherein the antigen is conjugated ... via
the C2-position" as opposed to the C6-position, as claimed. Id. at 10.
Appellants urge that the Seeberger Declaration "demonstrates the superiority
of a compound encompassed by claim 32 ... in terms of kinetics and
immunogenicity" compared to a prior art conjugate (ST3-CRM197 ). Id. at
10-11.
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Application 14/385,948
We are not persuaded by Appellants' arguments and agree with
Examiner's statement of the rejection and responses to Appellants'
arguments in both the Answer and Final Action, which we adopt and
incorporate by reference. We provide the following additional comments to
Appellants' arguments.
Appellants have not presented sufficient evidence to overcome the
presumption that Leadbetter is an enabling reference. See In re Morsa, 713
F.3d 104, 109 (Fed. Cir. 2013) ("[A] prior art printed publication cited by an
examiner is presumptively enabling barring any showing to the contrary by a
patent applicant or patentee."). Appellants rely on their attorney's argument
that "commonly used methods for peptide conjugation" will not work to
synthesize a conjugate of a carbohydrate antigen and a-GalCer because
"peptides and lipids (i.e., a-GalCer) differ fundamentally in their chemical
and physical properties, such as stability and solubility, thereby requiring
different conjugation reagents, linkers and different reaction conditions such
as solvents." See App. Br. 9. Examiner, however, found that Leadbetter
provides an exemplary reaction pathway for making a-GalCer conjugates in
Figure 2 and that this pathway could be adapted to conjugate a carbohydrate
antigen at the C6-position. Final Act. 4--5. In addition, Examiner found that
Leadbetter II "teaches the reagents used and conditions for synthesizing the
components and also provides [additional] references for the same ... [that]
would enable one of ordinary skill in the art to make the conjugates" in
claim 32. Id. at 8. Examiner's findings are supported by the underlying
references. See FF4--FF5. The mere fact that the specific antigen in
Leadbetter II is NP does not, as Appellants urge, demonstrate that one of
skill in the art would not be able to adapt the procedures taught there to
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Application 14/385,948
conjugate a carbohydrate antigen, as claimed. See App Br. 9-10. Therefore,
after fully considering the evidence and arguments before us, Appellants'
challenge to the presumptive enablement of the Leadbetter references
remains unpersuasive. See Morsa, 713 F.3d at 110.
We are also not persuaded by Appellants' argument that Leadbetter
does not render obvious conjugation at the C6-position of the sugar ring.
See App. Br. 10-11. While it is true that Leadbetter teaches that is
"preferred attachment site" is at C2, its disclosure is not limited to
attachment at that position. Leadbetter 3, 1. 13. Indeed, Leadbetter teaches
that the antigen can be conjugated at any position on the sugar ring and
specifically recites the C6-position for binding to the antigen. FF2.
We also disagree with Appellants' argument that the Seeberger
Declaration demonstrates "unique and unexpected advantages associated
with the claimed compounds" as compared to the prior art. App. Br. 10-11.
The Seeberger Declaration compares experimental results from "a
compound encompassed by claim 32 ... (ST3-GSL)" to a prior art
conjugate (ST3-CRM193). CRM193 is a protein. See Seeberger Deel. 45.
Thus, Appellants are relying on a comparison of one of their claimed
conjugates to an antigen-protein conjugate and not an antigen-a-GalCer
conjugate as taught in Leadbetter. Because Appellants' evidence does not
demonstrate unexpected results as compared to the closet prior art, it is not
persuasive here in outweighing the evidence of obviousness. In re Baxter-
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.").
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For all these reasons, Appellants' arguments fail to persuade us that
Examiner erred in rejecting claims 3 2, 3 6, 41, 4 2, 44--4 9, 51, and 5 5 as
obvious over Leadbetter, Leadbetter II, and Caddedu.
ODP Rejection of Claims 32, 36, 49, and 51
Examiner finds that claim 1 of Hacohen renders claims 32, 36, 49 and
51 obvious. Claim 1 of Hacohen read as follows: "A composition
comprising at least one mannose oligosaccharide conjugated to a molecule
selected from the group consisting of a protein or glycoprotein, a lipid,
chemically modified lipid, or glycolipid, polysaccharide, or small molecule,
wherein the composition is capable of binding to a protein present on a
dendritic cell." Hacohen col. 85, 11. 28-33. Examiner determines that the
"mannose oligosaccharide" in claim 1 is a carbohydrate antigen and the
claim teaches that this antigen may be conjugated to anyone of various
generic classes of molecules, such as a "glycolipid," which would include a-
GalCer. See Ans. 12; Final Act. 10.
In contrast to the generic classes of molecules recited in Hacohen
claim 1, Appellants argue that "claim 32 is directed to a specific glycolipid
(i.e., a-GalCer) having a defined structure .... " App. Br. 14. Thus,
Appellants contend that Examiner "has not established obviousness for the
specific sub-genus of compounds recited in Claim 32 in view of the broad
genus defined by Claim 1 of Hacohen." Id.
On this record, we find that Appellants have the better position with
respect to the ODP rejection. Accepting Examiner's logic that "mannose
oligosaccharide" is a species of the claimed carbohydrate antigen, Hacohen
claim 1 recites a Markush group of six classes of carrier molecules, each of
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Application 14/385,948
which is itself a broad genus of compounds, e.g., a "protein or glycoprotein,"
"glycolipid," "small molecule," etc. Examiner has not articulated a
sufficient rationale as to why it would be obvious for the skilled artisan to
select Appellants' claimed sub-genus ( a-Gal Cer) from the much broader
"glycolipid" genus taught in Hacohen claim 1. Accordingly, we reverse the
rejection of claims 32, 36, 49 and 51 for ODP over Hacohen claim 1.
SUMMARY
We affirm the rejection of claims 32, 36, 41, 42, 44--49, 51 and 55
under 35 U.S.C. § 103 over Leadbetter, Leadbetter II, and Cadeddu.
We reverse the rejection of claims 32, 36, 49, and 51 for obviousness-
type double patenting over claim 1 of Hacohen.
TIME PERIOD FOR RESPONSE
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
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