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 .
DETAILED ACTION
Claims 1-19 are pending and under examination.
Claim Objections
Claims 1, 2, are objected to because of the following informalities: the claims contain grammatical errors, redundant, and convoluted language.
In claim 1 and claim 11, all iterations of SEQ ID NO.: should be amended to SEQ ID NO:
In claim 2, the word “and” in line 3 should be amended to “or”.
Claim 8 may be amended to: The recombinant fusion protein of claim 1, wherein the linker fuses the first protein to the second protein.
In claim 9, “the” should be added before “first protein” and “second protein”. “Orientation” should be amended to “orientations”, and a comma is missing after “claim 1”.
Claim 10 may be amended to: An expression vector comprising the nucleotide sequence of claim 1.
Claim 12 should be amended to: said at least one recombinant fusion protein is present at a concentration of…said at least one non-fusion protein is present at a concentration of…said at least one additive is present at a concentration of…
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the polypeptides" in line 3. There is insufficient antecedent basis for this limitation in the claim.
In item c) of claim 1, the claim recites: nucleotide which is at least 80% similar to. It is unclear whether “similar to” means 80% sequence identity.
Claims 2-10 are also rejected as they depend from claim 1.
Claims 2, 3, 5, and 14-16 contain Markush groups, but recite open language, i.e., selected from the group comprising of. See MPEP 2173.05(h), which states “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group ‘consisting of’ (rather than ‘comprising’ or ‘including’) the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group ‘comprising’ or ‘consisting essentially of’ the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as ‘at least one member’ selected from the group), or within the list of alternatives (such as ‘or mixtures thereof’).” Claims 5 and 16 also recite “or” at the end of the list of alternatives instead of “and”, so the group of alternatives is not a closed group.
Regarding claim 3, the phrase "and the like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claim 8 recites: nucleotide which is at least 80% similar to. It is unclear whether “similar to” means 80% sequence identity.
Claim 11 recites the limitation "the polypeptides" in line 7. There is insufficient antecedent basis for this limitation in the claim. The claim also recites: nucleotide which is at least 80% similar to. It is unclear if “similar to” means 80% sequence identity or means something else.
Claims 12-19 are also rejected as they depend from claim 11.
Claim 12 recites protein and additive percentages but does not recite the units of concentration, i.e., wt%, % volume, etc. Therefore, the required percentage range of protein/additive is indefinite.
Regarding claim 18, the phrase "and the like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Claim 19 is indefinite because it can be interpreted as an intended use limitation, or as a “use” claim that attempts to claim a process without setting forth any steps involved in the process. MPEP § 2173.05(q) states that attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 19 recites: dairy and related products. It is unclear what are considered products that are related to dairy as the term “related products” is not defined in the specification.
Claim Rejections - 35 USC § 112(a)
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 1-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-10 are drawn to a recombinant fusion protein comprising:
at least a first protein comprising an amino acid sequence having at least 80% sequence identity to the polypeptides as encoded by a nucleotide sequence selected from SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, and SEQ ID NO:7.
at least a second protein comprising an amino acid sequence having at least 80% sequence identity to the polypeptides as encoded by a nucleotide sequence consisting of SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, and SEQ ID NO:13, and
at least a linker comprising an amino acid sequence coded by nucleotide sequence which is at least 80% similar to sequences selected from the group consisting of SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, and SEQ ID NO:21.
Claims 11-19 are drawn to a composition comprising:
at least a first protein comprising an amino acid sequence having at least 80% sequence identity to the polypeptides as encoded by a nucleotide sequence selected from SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, and SEQ ID NO:7.
at least a second protein comprising an amino acid sequence having at least 80% sequence identity to the polypeptides as encoded by a nucleotide sequence consisting of SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, and SEQ ID NO:13, and
at least a linker comprising an amino acid sequence coded by nucleotide sequence which is at least 80% similar to sequences selected from the group consisting of SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, and SEQ ID NO:21.
MPEP 2163.05 II states “the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that ‘only describe[d] one type of structurally similar antibodies’ that ‘are not representative of the full variety or scope of the genus.’). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us].’”
There are no prior art references that teach a fusion protein comprising:
a polypeptide encoded by a nucleotide sequence with at least 80% sequence identity to SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, or SEQ ID NO:7,
a polypeptide encoded by a nucleotide sequence with at least 80% sequence identity to SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21,
and a linker encoded by a nucleotide sequence with at least 80% sequence identity to SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, or SEQ ID NO:21.
The specification does not disclose all nucleotide sequences with up to 20% sequence divergence from instant SEQ ID NOs:1-21. Therefore, the disclosed species are not representative of the entire genus of nucleotide sequences that share 80% sequence identity to instant SEQ ID NOs:1-21.
In summary, neither the instant specification, nor the prior art, discloses a structure-function relationship between conserved nucleotide residues and taste profile of the encoded protein. One of ordinary skill in the art cannot reasonably predict which residues of SEQ ID NOs:1-21 may be modified to generate fusion protein that may be used as a dairy substitute. Based on the instant disclosure, those skilled in the art would not conclude that the applicant was in possession of all claimed variants.
To obviate the rejection, Applicant may consider the following amendment, which has been drafted by the Examiner:
Claim 1. A recombinant fusion protein comprising:
at least a first protein encoded by the nucleotide sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, and SEQ ID NO:7;
at least a second protein encoded by the nucleotide sequence selected from the group consisting of SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, and SEQ ID NO:13; and
at least a linker peptide encoded by the nucleotide sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, and SEQ ID NO:21.
Claim 11. A composition comprising:
at least one recombinant fusion protein;
at least one non-fusion protein; and
at least one additive,
wherein the at least one recombinant fusion protein comprises:
at least a first protein encoded by the nucleotide sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, and SEQ ID NO:7;
at least a second protein encoded by the nucleotide sequence selected from the group consisting of SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, and SEQ ID NO:13; and
at least a linker peptide encoded by the nucleotide sequence selected from the group consisting of SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19, SEQ ID NO:20, and SEQ ID NO:21.
Pertinent Prior Art
The closest prior art reference is that of Lanquar et al., (US 10,947,552 B1). Lanquar teaches recombinant fusion proteins comprising a milk protein and a structured mammalian, avian, plant, or fungal protein (Abstract). Lanquar teaches that the fusion protein may comprise beta-lactoglubulin (instant SEQ ID NO:1) or kappa-casein (instant SEQ ID NO:3). However, Lanquar does not teach that the fusion protein may comprise brazzein (instant SEQ ID NO:8), thaumatin (SEQ ID NO:9), monellin (SEQ ID NO:10), miraculin (SEQ ID NO:11), curculin (SEQ ID NO:12), or neoculin (SEQ ID NO:13). Moreover, the nucleotide sequences of Lanquar encoding beta-lactoglobulin and kappa-casein do not share 80% sequence identity to instant SEQ ID NO:1 or 3.
The closest prior art sequence to instant SEQ ID NO:1 is SEQ ID NO:101 of Pandya et al., (US20170164632A1), which shares 73.8% sequence identity to instant SEQ ID NO:1. The closest prior art sequence to instant SEQ ID NO:2 is SEQ ID NO:157 of Pandya et al., (US20170164632A1), which shares 81.9% sequence identity to instant SEQ ID NO:2. The closest prior art sequence to instant SEQ ID NO:3 is SEQ ID NO:148 of Pandya, which shares 81.5% sequence identity to instant SEQ ID NO:3. The closest prior art sequence to instant SEQ ID NO:4 is SEQ ID NO:22 of Carr et al., (US20020192744A1), which shares 83.5% sequence identity to instant SEQ ID NO:4. The closest prior art sequence to instant SEQ ID NO:5 is SEQ ID NO:145 of Pandya, which shares 78.7% sequence identity to instant SEQ ID NO:5. The closest prior art sequence to instant SEQ ID NO:6 is that of . The closest prior art sequence to instant SEQ ID NO:7 is SEQ ID NO:144 of Pandya, which shares 81.2% sequence identity with instant SEQ ID NO:7. Neither Pandya nor Carr teach any one of SEQ ID NOs:1-7 as part of a fusion protein.
The closest prior art sequences to instant SEQ ID NOs:8-13 are: SEQ ID NO:5 of Hellekant et al., (US Patent No. 5527555), which shares 79.2% sequence identity to instant SEQ ID NO:8, SEQ ID NO:21 of Stahl et al., (US20090031458A1), which shares 100% sequence identity with instant SEQ ID NO:9, GenBank Accession No. JQ282905.1 submitted 03/31/2012 by Jin, X.Y., et al., which shares 100% sequence identity to instant SEQ ID NO:10, SEQ ID NO:10 of Ezura et al., (US20090205068A1), which shares 100% sequence identity to instant SEQ ID NO:11, SEQ ID NO:1 of Abe (US20080305522A1), which shares 99.7% sequence identity to instant SEQ ID NO:12, SEQ ID NO:1 of Abe (US20080305522A1), which shares 99.7% sequence identity to instant SEQ ID NO:13.
The closest prior art sequence to instant SEQ ID NOs:14-21 are: SEQ ID NO:140254 of Plesch et al., (US20140259212A1), which shares 100% sequence identity to instant SEQ ID NO:14, SEQ ID NO:325 of Blasing et al., (US20110098183A1), which shares 92.4% sequence identity to instant SEQ ID NO:15, GenBank Accession AC095642, submitted 05/09/2003 by Muzny et al., which shares 63.3% sequence identity with instant SEQ ID NO:16, SEQ ID NO:38552 of Abad et al., (US20070234438A1), which shares 89.2% sequence identity to instant SEQ ID NO:17, SEQ ID NO:812 of Bratzler et al., (US20040067902A1), which shares 100% sequence identity to instant SEQ ID NO:18, SEQ ID NO:496584 of Bentwich (US20060003322A1), which shares 100% sequence identity to instant SEQ ID NO:19, GenBank Accession No. AM910985, submitted 11/23/2007 by Boehme et al., which shares 76.7% sequence identity to instant SEQ ID NO:20, and GenBank Accession AK265497, submitted 07/26/2007 by Noji et al., which shares 100% sequence identity to instant SEQ ID NO:21. The prior art does not teach SEQ ID NO:14-21 as linker sequences that may be incorporated into fusion proteins.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657