DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The response filed 12-19-2025 has been entered into the record.
Drawings
The drawings in this application have been accepted. No further action by Applicant is required.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Information Disclosure Statement
The information disclosure statements have been considered. Initialed copies are enclosed.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12-19-2025 is acknowledged. Claims 49-55 are under examination. Claims 56-66 are withdrawn from consideration as drawn to a non-elected invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 49-54 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,986,704 Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims 49 and 53-55 recite a polypeptide comprising serotype 2 OspA fragments comprising SEQ ID NO:219 and variants of 95% identical to residues 126-273 of SEQ ID NO:19 and differs by the addition of at least one disulfide bond and pharmaceutical compositions comprising such. The homodimeric polypeptide having the structure S2D1 in the claims 1-12 of the ‘704 patent and intended use as a vaccine anticipates the instant claims herein. The inclusion of conventional adjuvants in a vaccine is prima facie obvious.
Instant dependent claims 50-52 are anticipated by claims 1-12 of the ‘704 Patent in view of the recitation of Lip-S1D1-S2D1 (SEQ ID NO:186) and Lip-S2D1-S1D1 (SEQ ID NO:192) in pharmaceutical compositions comprising excipients and carriers therein.
Claims 49-55 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 6-9 of U.S. Patent No. 10,544,194. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 6-9 of the ‘704 patent recite Lip-S1D1-S2D1 (SEQ ID NO:186) where S2D1 per se anticipates claim 49. The pharmaceutical compositions of claims 6-9 of the ‘704 Patent comprising Lip-S1D1-S2D1 (SEQ ID NO:186) comprising a pharmaceutically acceptable excipient or carrier, wherein the carrier can be L-methionine and/or aluminum hydroxide anticipates claims 50-55.
Claims 49-55 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 13 and 15-17 of U.S. Patent No. 11,208,439. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the ‘439 patent recite Lip-S1D1-S2D1 (SEQ ID NO:186), Lip-S2D1-S1D1 (SEQ ID NO:192), Lip-S1D4-S2D1 (SEQ IDNO:197) and S2D1-S1D4 (SEQ IDNO:204) anticipate claims 49-52. The S2D1 is a polypeptide that meets the limitation set forth in claim 49 and the heterodimeric polypeptides correspond to those recited in instant claims 50-52. The pharmaceutical compositions comprising these heterodimeric polypeptides (claims 15-17) anticipate the instant claims 53-55 as the compositions comprises a polypeptide that meets the limitation of the claims and has a pharmaceutically acceptable carrier or excipient of aluminum hydroxide (see claim 17 of the patent).
Claims 49-55 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 5-10 of U.S. Patent No. 11,466,058. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 5 and 8 of the ‘058 Patent recite a composition comprising the protein Lip-S1D1-S2D1 (SEQ ID NO:186). The S2D1 portion recited (i.e. the heterodimer comprises S2D1) and therefore meets the limitation of claim 49 and the full-length heterodimers meet the limitation of instant claims 50-52 along with a pharmaceutically acceptable carrier or excipient wherein the excipient is L-methionine and/or aluminum hydroxide (claims 8-10 of the ‘058 patent) meet the limitations of instant claims 53-55.
Claims 49-55 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 4, and 7-8 of U.S. Patent No.US 9,975,927. Although the conflicting claims are not identical, they are not patentably distinct from each other because the pharmaceutical composition of SEQ ID NO:29 and compositions comprising a carrier or excipient of the patented claims comprises S1D1-S2D1 of SEQID NO:186 and has S2D1 which anticipates instant claim 49. As such, the pharmaceutical compositions comprising SEQ ID NO:29 anticipates claim 49, 53, and 54 herein.
Claims 49-55 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 10-12 of U.S. Patent No. 10,766,931. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent claim 11 recites a pharmaceutical composition comprising Lip-S1D1-S2D1 of SEQ ID NO:29 is identical with LipS1D1-S2D1 (SEQ ID NO:186) set forth in instant claims 50-52 as such the claims are anticipated. The S2D1 portion anticipates instant claim 49 herein and it likewise anticipated by the patented claim 11. Additionally, the ‘931 patent indicates that the pharmaceutical compositions can comprise excipients (claim 10) and that the excipients can comprise L-methionine and/or alum (claim 12). As such it would have been obvious to the skilled artesian at the time of filing to add the excipients of claim 11 to the pharmaceutical composition of claim 11 to arrive a the instantly claimed compositions of claims 53-55.
Claims 49-53 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No.12,514,912. Although the conflicting claims are not identical, they are not patentably distinct from each other because the administration of fusion protein comprising the Lip-S1D1-S2D1 having SEQ ID NO:1 is identical to that of SEQ ID NO:186 Lip-S1D1-S2D1 claimed herein. As such Lip-S1D1-S2D1 having SEQ ID NO:1 of the ‘912 Patent anticipates instant claims 49-53.
Claims 49-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 19/401,907. The ‘907 application teach compositions to be administered to humans comprising Lip S1D1-S2-D1 (SEQ ID NO:1) where the compositions further comprise an aluminum adjuvant. The compositions anticipate the instant claims as S2D1 meets the structure of the claimed serotype 2 fragment and Lip-S1D1-S2D2 has the same structure as instantly claimed.
This is a provisional nonstatutory double patenting rejection.
Free of Prior Art
Claims 49-55 are free of the prior art. The closest prior art is Crowe et al (US 2011/0293652, December 1, 2011) which teaches a Serotype 1 OspA/Serotype 2 OspA fusion protein which is optionally lapidated. While Crowe et al broadly contemplate variants of OspA and conservative variants, Crowe et al does not teach serotype 2 OspA having cysteine replacements or cysteine variants that provide for the addition of at least one disulfide bond. The prior art does not teach or suggest either the inclusion of the disulfide bonds or the specific positional variants of SEQ ID NO:219 from OspA serotype 2.
Status of the Claims
All claims stand rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached on 7:30 am-5:30 pm, M-Th.
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/PATRICIA DUFFY/Primary Examiner, Art Unit 1645
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