DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with partial traverse of Group I, claims 1, 2, 8, 10, 16, 19, 21, 22, 25, 26, 28, 31-33, 38, 41, and 80-85 in the reply filed on August 27, 2025 is acknowledged.
The traversal is on the grounds that Groups I and III are related as combination and sub-combination. This is not found persuasive because the present restriction requirement is based on the lack of unity of invention, as discussed in the restriction requirement on April 30, 2025. Since Frangione et al. (US Patent 7,479,482) teach the claimed polypeptide, as discussed in the 35 U.S.C. 102 art rejection below, Applicant’s invention does not contribute a special technical feature when viewed over the prior art they do not have a single inventive concept and thus the claims lack unity of invention. Therefore, the instant invention lacks Unity of Invention and restriction is set forth as it applies to U.S. practice. the requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 27, 2022 and November 10, 2021 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 8, 10, 16, 19, 21, 22, 25, 26, 28, 31-33, 38, 41, and 84-85 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are drawn to an isolated protein or peptide thereof comprising the amino acid sequence of an isolated protein or polypeptide thereof comprising the an amino acid sequence of at least 15 and up to 50 consecutive amino acids from the amino acid sequence of SEQ ID NO: 1
MX2X3X4XsX6GXgw Xi0L Xi2LFV X16X17W X19D X21G X23 CK K X27PK PGGX33 WNTGG X39SR YPGQGX47PGGNR YP XssQGGXs59X60W GQPHGGGW GQPHGGX76W GQPHGGX34WG QPHGGXo92X93 X94. X95 X96 X97 X98X99X100GWGQX 105GX107X10sHX110QW X113KPX116KPKTX121 Xi2KHXi2sAGAAAAGAVVGGLGGY X142LGSAMSRP X15) JHFGX1s6DX1ssEDRY YRENMX}1 68RYPX172QVY Y X177PX179 X1g0X181 Y X183X184QN X1s7F V X190 DC VNITX 197K X199 HT VT TTTKG ENFTETD X216K X21sME X221 VVEQMC X228TQ Y X232X233 EX235X236 AX238X239 X240 X241 X242 X243 X244 X24s X246 X247 X248 X249 FSX252PPV X2s6LLIS X261L1X264 LIVX268 (SEQ ID NO: 1)
wherein X2is V or A; X3is K or null; X4is S or null; Xs is N or H; Xeis I, V, L or M; Xg is S$, G, Y or C; X10 is I, L or M; Xi2 is V, A, or L; X16 is A, T, or V; Xi7is T or M; Xi9 is S or T; X21 is V, I, M; X23 is L or F; X27 is R or W; X33 is G or null; X39 is G or null; X47S or I; Xs5518 P or S; Xs9is G or null; X6o0is G or T; X71s G or S; Xg4is G or S; Xo2 is G or null; X93 1s W or null; Xo41s G or null; X95 is Q or null; X96is P or null; X971s H or null; X9gis G or null; X99 is Gor null;; X100is G or null; X1osis G or S; X107is G or null; Xiogis T, A, or S; X110is G, N, or S; X1i3is N or G; Xiieis S or N; Xi21 1s N or S; X122is M or L; Xi2sis V or M; X142is M or L; Xisiis L, M or i; Xis6is N or S; Xisgis Y or W; Xiegis Y or H; Xi72is N or E; X1771is R or K; X179 is V or M; Xisois D, N or S; X1g1is Q, R or E; Xig3is S or N; Xigais N or S; Xig7is N, S, or T, X19018 H or R; Xi97is V or I; Xi99is Q or E; X216is V, M or I; X21¢1s M or I; X221 is R or Q; X228 1s I or V; X2321s Q, E, or R; X233 R, Q, or K; X235is S or Y; X23618 Q or E; X23 18 Y, S, F, or A; X23918 Y or Q; X24018 Q, D, or G; X24118 G or null; X242 R or null; X2431s R or K; X244 is G, S, or A; X24sis A or S; X246is S or G; X2471s V, T, A, M or null; X24gis I, L, V; X249is L or I; X252 is S or P; X2s6is I or V; X2611s F or L; X264is F or L; X26gis G or R; and wherein the isolated protein or polypeptide thereof comprises at least two single amino acid variations from a corresponding of any one of prion proteins of SEQ ID Nos: 2-34.
Claims are rejected because there is a lack of structure and function correlation between the multiple variants of present SEQ ID NO: 1 and the required function of a vaccine comprising multiple copies of the claimed variants.
Additionally, the recitation of “at least two single amino acid variations from a corresponding of any one of prion proteins of SEQ ID Nos: 2-34” makes the claimed genus even larger, without knowing which variations from SEQ ID NO: 2-34 are to be incorporated within already very variable SEQ ID NO: 1.
Applicant’s specification lists a number of species that are able to perform the claimed function, such as SEQ ID NO: 64, 65, 66, 67, 68 and 69.
Example 1 in Applicant’s specification discusses plasmid construction comprising live attenuated Salmonella LVR01 expressing multiple species of peptides and inoculation of transgenic mice with the Salmonella prion vaccine. Example 1 states that the results indicate that all intestinal antibodies developed by the different multi-species combination inoculations reacted with all species of actual prion protein PrP from different species prionic disease (Figure 6).
Applicant’s specification does not show how many different variants of SEQ ID NO: 1 were comprises in the Salmonella prion vaccine.
Thus, because of the lack of structure and function correlation between the large genus of SEQ ID NO: 1 variants and the required function a vaccine against prior disease, and the lack of sufficient written description support for the claimed genus, the present claims are rejected as failing to comply with the written description requirement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 8, 10, 16, 21, 26, 28, 81, 84 and 85 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Frangione et al. (US Patent 7,479,482).
Frangione et al., disclose a prion protein comprising an amino acid sequence having at least 15 and up to 50 consecutive amino acids from SEQ ID NO: 1 (see sequence alignment below and SEQ ID NO: 27 in Frangione) comprising at least two single amino acids variations from a corresponding prion protein of SEQ ID NO: 2 (see SEQ ID NO: 27 in Frangione) and comprising a sequence identical with present SEQ ID NO: 35 (see SEQ ID NO: 31 in Frangione).
Regarding present claim 21, Frangione teach that the prior peptides have the tendency to polymerize and teach a conjugate in which a polypeptide or peptide of the present invention is cross-linked to an immunostimulatory polymer molecule (see column 14, lines 40-44).
Regarding present claims 16 and 26, Frangione teaches prion polypeptide further comprising an adjuvant linked to the polypeptide (see claims 7 and 8, and colums ).
Present SEQ ID NO: 1 and SEQ ID NO: 27 in Frangione
Query Match 91.5%; Score 1000; Length 258;
Best Local Similarity 70.0%;
Matches 187; Conservative 0; Mismatches 70; Indels 10; Gaps 3;
Qy 1 MXXXXXGXWXLXLFVXXWXDXGXCKKXPKPGGXWNTGGXSRYPGQGXPGGNRYPXQGGXX 60
| | | | ||| | | | ||| ||||| ||||| ||||||| ||||||| |||
Db 1 MVKSHIGSWLLVLFVATWSDIGFCKKRPKPGGGWNTGG-SRYPGQGSPGGNRYPPQGGGG 59
Qy 61 WGQPHGGGWGQPHGGXWGQPHGGXWGQPHGGXXXXXXXXXGWGQXGXXHXQWXKPXKPKT
||||||||||||||| ||||||| ||||||| |||| | | || || ||||
Db 60 WGQPHGGGWGQPHGGGWGQPHGGGWGQPHGG--------GGWGQGGGSHGQWGKPSKPKT 111
Qy 121 XXKHXAGAAAAGAVVGGLGGYXLGSAMSRPXIHFGXDXEDRYYRENMXRYPXQVYYXPXX
|| |||||||||||||||| |||||||| |||| | ||||||||| ||| |||| |
Db 112 NMKHVAGAAAAGAVVGGLGGYMLGSAMSRPLIHFGNDYEDRYYRENMYRYPNQVYYKPVD 171
Qy 181 XYXXQNXFVXDCVNITXKXHTVTTTTKGENFTETDXKXMEXVVEQMCXTQYXXEXXAXXX
| || || |||||| | |||||||||||||||| | || |||||| ||| | |
Db 172 QYSNQNNFVHDCVNITVKQHTVTTTTKGENFTETDMKIMERVVEQMCVTQYQRESEA-AY 230
Qy 241 XXXXXXXXXFSXPPVXLLISXLIXLIV 267
|| ||| |||| || |||
Db 231 YQRGASAILFSPPPVILLISLLILLIV 257
Present SEQ ID NO: 2 and SEQ ID NO: 27 in Frangione
Query Match 94.6%; Score 1369.5; Length 258;
Best Local Similarity 94.6%;
Matches 245; Conservative 6; Mismatches 5; Indels 3; Gaps 3;
Qy 1 MVKSHIGGWILLLFVATWSDVGLCKKRPKP-GGWNTGGGSRYPGQGSPGGNRYPPQGGGG 59
||||||| |:|:||||||||:| ||||||| ||||| |||||||||||||||||||||||
Db 1 MVKSHIGSWLLVLFVATWSDIGFCKKRPKPGGGWNT-GGSRYPGQGSPGGNRYPPQGGGG 59
Qy 60 WGQPHGGGWGQPHGGGWGQPHGGGWGQPHGGGGWGQGGGSHSQWGKPNKPKTNMKHVAGA
||||||||||||||||||||||||||||||||||||||||| |||||:||||||||||||
Db 60 WGQPHGGGWGQPHGGGWGQPHGGGWGQPHGGGGWGQGGGSHGQWGKPSKPKTNMKHVAGA 119
Qy 120 AAAGAVVGGLGGYMLGSAMSRPLIHFGNDYEDRYYRENMYRYPEQVYYRPVDQYSNQNNF
||||||||||||||||||||||||||||||||||||||||||| ||||:|||||||||||
Db 120 AAAGAVVGGLGGYMLGSAMSRPLIHFGNDYEDRYYRENMYRYPNQVYYKPVDQYSNQNNF 179
Qy 180 VRDCVNITVKQHTVTTTTKGENFTETDMKIMERVVEQMCVTQYQKESE-AYYQRGASAIL
| ||||||||||||||||||||||||||||||||||||||||||:||| |||||||||||
Db 180 VHDCVNITVKQHTVTTTTKGENFTETDMKIMERVVEQMCVTQYQRESEAAYYQRGASAIL 239
Qy 239 FSPPPVILLISLLILLIVG 257
|||||||||||||||||||
Db 240 FSPPPVILLISLLILLIVG 258
Present SEQ ID NO: 35 and SEQ ID NO: 31 in Frangione wherein X55 is S, X59 is G and X60 is G
Query Match 98.6%; Score 138; Length 263;
Best Local Similarity 87.5%;
Matches 21; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 RYPXQGGXXWGQPHGGGWGQPHGG 24
||| ||| |||||||||||||||
Db 51 RYPSQGGGGWGQPHGGGWGQPHGG 74
Thus, by this disclosure, Frangione anticipate the present claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 8, 10, 16, 19, 21, 22, 25, 26, 28, 31-33, 38, 41, 81, 84 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Frangione et al. (US Patent 7,479,482) in view of Wisniewski et al. (US Patent 9,926,353).
Frangione et al., disclose a prion protein comprising an amino acid sequence having at least 15 and up to 50 consecutive amino acids from SEQ ID NO: 1 (see sequence alignment below and SEQ ID NO: 27 in Frangione) comprising at least two single amino acids variations from a corresponding prion protein of SEQ ID NO: 2 (see SEQ ID NO: 27 in Frangione) and comprising a sequence identical with present SEQ ID NO: 35 (see SEQ ID NO: 31 in Frangione).
Regarding present claim 21, Frangione teach that the prior peptides have the tendency to polymerize and teach a conjugate in which a polypeptide or peptide of the present invention is cross-linked to an immunostimulatory polymer molecule (see column 14, lines 40-44).
Regarding present claims 16 and 26, Frangione teaches prion polypeptide further comprising an adjuvant (see claims 7 and 8).
Frangione does not teach glutaraldehyde and containing the GSG linker
Regarding present claims 19, Wisniewski teaches prion proteins polymerized with glutaraldehyde and containing the GSG linker linked with adjuvants (see column 13, lines 1-67, column 15, lines 40-67,
Regarding present claims 21, 22, 25, 26, 31, 32, 33, Wisniewski teaches polymeric prion proteins (see claims 1-18, column 13, lines 25-60).
Regarding claims 33, 38, and 41, Wisniewski teaches a recombinant bacteria transformed with a vector prion protein (column 14, lines 19-54).
It would have been prima facie obvious at the time of the present invention to provide the composition of Frangione and to modify it as suggested by Wisniewski to provide prion protein polymers expressed by bacterial vectors, because Wisniewski teaches that prion proteins in polymeric form are useful for treatment and prevention of amyloid disease (see Abstract, Figures 3 and 4 and figure description in column 3).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Claim Objection
Claims 80, 82 and 83 are objected to for depending from rejected base claim but they would be allowable if amended to incorporate all limitations of the claims they depend from.
Conclusion
Claims 80, 82 and 83 are free of prior art.
Contact Information
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648