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 without traverse of claims 1-7 in the reply filed on 12/10/2025 is acknowledged. Applicant’s election without traverse of the species [1] a protein consisting of the amino acid sequence represented by SEQ ID NO: 2, 4, 6, 8, or 10; SEQ ID NO: 2; and position 9 in claim 1 in the reply filed on 3/17/2026 is acknowledged.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the replies filed on 12/10/2025 and 3/17/2026.
In view of the prior art search, the species election is expanded to include option [3] and residue 238 in claim 1.
Priority
This application is a 371 of PCT/JP2022/006790 (2/18/2022) which claims priority to JP2021-025170 (2/19/2021).
The certified copy of the foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
The effective filing date is considered to be 2/18/2022. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 8/18/2023, 10/9/2023, and 12/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “I to 20 amino acids” This should instead be “1 to 20 amino acids”. Appropriate correction is required.
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 1-7 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.
Regarding written description, 35 U.S.C. 112(a) and the first paragraph of pre-AlA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention (MPEP § 2163(I)).
MPEP 2163(II)(A)(3)(a)(i and ii) states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., .759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, claim 1 recites “a homologous protein having an α -1,2-fucosyltransferase activity and consisting of an amino acid sequence having an identity of 80% or more with the amino acid sequence represented by SEQ ID NO: 2”. Claim 1 additionally recites that the protein has an improved α-1,2-fucosyltransferase activity. There is not sufficient written description support for a protein with a sequence that is 80% identical to SEQ ID NO: 2, with mutations at the claimed positions, which has the claimed activity. The specification does not indicate which residues are critical for function, i.e. which regions or residues may or may not be mutated to obtain a protein with the claimed function, other than the specifically disclosed residues that are mutated. SEQ ID NO: 2 has 286 amino acid residues. This means that up to 57 residues may differ from the wildtype sequence. This encompasses a vast number of potential sequences, and it is not clear which of these would maintain the claimed activity. While there is written description support for the specifically disclosed SEQ ID NOs and residue mutations, these are not representative of the entire genus of sequences which are 80% identical to SEQ ID NO: 2, and it is not clear which of these many sequences would have the claimed activity.
For these reasons, claim 1 fails to comply with the written description requirement, as it is not clear that the applicant had possession of the full scope of the invention at the time of filing.
Claims 2-7 are included in this rejection because they depend on a rejected claim and do not clarify the issue.
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 1-7 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.
The term “improved” in claim 1 is a relative term which renders the claim indefinite. The term “improved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. On page 12 of the instant specification, it states that “it can be confirmed that the α-1,2-fucosyltransferase activity of the protein is improved as compared with the original protein by detecting the fucose-containing carbohydrate in the reaction liquid using a carbohydrate analyzer”. However, it is not clear what degree of difference between fucose-containing carbohydrates is required to consider the activity “improved” compared to an original protein. Thus, the full scope of what is considered a protein with improved α-1,2-fucosyltransferase activity would not be clear to a skilled artisan.
Claims 2-7 are included in this rejection because they depend on a rejected claim and do not clarify the issue.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 3-4, and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Martin et al., US 2024/0279698 A1 (effective filing date 8/5/2021).
Regarding claim 1, Martin teaches fucosyltransferase proteins and associated sequences for production of human milk oligosaccharides (Martin p. 1 para. 1). Martin teaches a sequence, SEQ ID NO: 11, that is 88.9% identical to instant SEQ ID NO: 2 with a substitution at position 238 (see sequence alignment in OA appendix).
Regarding the limitation “having an improved α-1,2-fucosyltransferase activity”, this is a functional limitation of the claimed protein. Any protein having the same structure as the claimed protein must necessarily have the same function, absent any unclaimed essential features. A protein having the same structure as claimed, i.e. consisting of a sequence having an identity of 80% or more with SEQ ID NO: 2 and having a substitution at residue 238, is taught by Martin. Therefore, the protein taught by Martin is considered to be capable of the claimed function.
Regarding claims 3-4 and 6, Martin teaches a protein with a sequence according to SEQ ID NO: 11, which is 88.9% identical to instant SEQ ID NO: 2 and has a substitution of alanine at position 238 (see sequence alignment in OA appendix).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over McCoy et al., US 2017/0081353 A1.
Regarding claim 1, McCoy teaches α-1,2-fucosyltransferase proteins and associated sequences for production of human milk oligosaccharides (p. 1 para. 2-4). McCoy teaches an α-1,2-fucosyltransferase from Helicobacter mustelae with a sequence according to SEQ ID NO: 2, that is 100% identical to instant SEQ ID NO: 2 (McCoy p. 9 para. 77; see sequence alignment in OA appendix). McCoy teaches that changes can be introduced by mutation into the nucleic acid sequence or amino acid sequence of any of the genes or gene products described, and that substitutions at non-essential amino acid residues can be made in the sequence of any of sequences expressly disclosed (McCoy p. 13 para. 86). Non-essential amino acid residues are those that are poorly conserved among members of the protein family and are more likely to be amenable to alteration (McCoy p. 13 para. 86). McCoy teaches a sequence alignment of Helicobacter mustelae FutL with other α-1,2-fucosyltransferase sequences (see Fig. 3B). The amino acid residue at position 9 of FutL is not highly conserved among homologous sequences (see Fig. 3B, Fig. 4).
It would have been obvious for a skilled artisan to arrive at an α-1,2-fucosyltransferase protein with a sequence consisting of the amino acid sequence represented by SEQ ID NO: 2, with a substitution of another amino acid at position 9. McCoy teaches a sequence that is identical to instant SEQ ID NO: 2, and also teaches that the α-1,2-fucosyltransferase sequences may be substituted, particularly at residues that are considered non-essential, i.e. not highly conserved among homologous proteins. Residue 9 of H. mustelae FutL is not highly conserved among other proteins in the family, as shown in McCoy Figs. 3 and 4. Therefore, a protein with a sequence consisting of instant SEQ ID NO: 2 with a substitution at position 9 is considered obvious, and a skilled artisan would have had a reasonable expectation of success in obtaining such a protein, as it is known that substitutions may be introduced at non-essential residues.
Regarding the limitation “having an improved α-1,2-fucosyltransferase activity”, this is a functional limitation of the claimed protein. Any protein having the same structure as the claimed protein must necessarily have the same function, absent any unclaimed essential features. A protein having the same structure as claimed, i.e. consisting of the sequence according to SEQ ID NO: 2 and having a substitution at residue 9, is obvious in view of McCoy. Therefore, the protein taught by McCoy is considered to have the claimed function.
Regarding claim 2, the amino acids at residues 68, 75, 86, and 238 are not highly conserved among α-1,2-fucosyltransferase proteins (see McCoy Figs. 3 and 4). Thus, a protein with a sequence consisting of instant SEQ ID NO: 2 with a substitution at positions 9, 68, 75, 86, and 238 is considered obvious, and a skilled artisan would have had a reasonable expectation of success in obtaining such a protein, as it is known that substitutions may be introduced at non-essential residues as taught by McCoy.
Regarding claims 3-5, McCoy teaches that preferably, conservative amino acid substitutions are made at one or more predicted non-essential amino acid residues, and that conservative substitutions are ones in which the amino acid residue is replaced with an amino acid residue having a similar side chain (McCoy p. 13 para. 88). McCoy teaches that families of amino acids having similar side chains are known in the art, and that lysine, arginine, and histidine are amino acids with basic side chains (McCoy p. 13 para. 88). Residue 9 of SEQ ID NO: 2 is a histidine. Therefore, it would have been obvious for a skilled artisan to make a conservative substitution at this predicted non-essential residue, i.e. a substitution of histidine for lysine or arginine.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Martin et al., US 2024/0279698 A1 (effective filing date 8/5/2021) in view of McCoy et al., US 2017/0081353 A1.
Martin teaches a protein with a sequence according to SEQ ID NO: 11, which is 88.9% identical to instant SEQ ID NO: 2 and has a substitution of alanine at position 238 (see sequence alignment in OA appendix).
Martin does not teach that the protein has an amino acid sequence with a substitution of arginine at position 9.
Regarding claim 7, McCoy teaches an α-1,2-fucosyltransferase from Helicobacter mustelae, and teaches that substitutions at non-essential amino acid residues can be made in the sequence of any of sequences expressly disclosed, which includes residues 9 and 238 as discussed above (McCoy p. 13 para. 86; Figs. 3 and 4).
McCoy teaches that preferably, conservative amino acid substitutions are made at one or more predicted non-essential amino acid residues, and that conservative substitutions are ones in which the amino acid residue is replaced with an amino acid residue having a similar side chain (McCoy p. 13 para. 88). McCoy teaches that families of amino acids having similar side chains are known in the art, and that lysine, arginine, and histidine are amino acids with basic side chains (McCoy p. 13 para. 88). Residue 9 of SEQ ID NO: 2 is a histidine.
Therefore, it would have been obvious for a skilled artisan to modify the protein of Martin which has a substitution of alanine at position 238, and make a conservative substitution to arginine at position 9. As residue 9 is a predicted non-essential residue, a protein with a conservative mutation at this residue is considered obvious in view of the prior art.
Conclusion
Claims 1-7 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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