DETAILED ACTIONNotice 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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/JP2021/032154, filed 09/01/2021. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2020-149797, filed on 09/07/2020 in Japan.
Status of the Claims
Claims 1-5 are pending; claims 1 and 4 are amended; claims 1-5 are examined below.
In the interest of compact prosecution, Applicant’s amendment has been entered. However, it is noted that claim 3, submitted 10/24/2025, is not in compliance with the patent rules regarding the manner of making amendments to the claims, set forth in the MPEP (See MPEP 714). These claims are presented with a status of “Original” but the text of the claims was previously amended. See specifically, previously omitted language “or 2” which was shown with strike through in previous amendments to the claims (see claims 09/09/2022) is shown as restored at claims filed 10/24/2025, however the text added back is not shown as underlined, and the claim should be indicated with the status “amended”.
Withdrawn Objections/Rejections
The previous objection to the drawings is withdrawn in response to Applicant’s amended drawings (filed in black and white).
The previous rejections of claims under 35 U.S.C. 102 and 35 U.S.C. 103, citing Adachi as primary reference, are withdrawn in response to Applicant’s amendments to the claims.
The previous rejections of claims under 35 U.S.C. 102 and 35 U.S.C. 103, citing Yamanaka et al. are withdrawn in response to Applicant’s submission of the certified English translation of the foreign application in order to perfect the foreign priority claim, as well as Applicant’s amendments to the claims.
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 1-5 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. See MPEP 2163.
Claim 1 recites “β-1,6-glucan binding protein is a β-1,6-glucanase mutant having no cleavage activity of a β-1,6-glucan and having specific binding activity to a β-1,6-glucan”, the claim is directed to a particular β-1,6-glucanase mutant described in terms of function rather than structure, namely that is “a β-1,6-glucan binding protein… having no cleavage activity of a β-1,6-glucan and having specific binding activity to a β-1,6-glucan”.
Regarding Applicant’s actual reduction to practice, Applicant’s originally filed specification at para [0061] refers to a specific species of mutant that meets the functional requirements claimed, namely a mutant derived from Neurospora crassa (Neg1-E321Q), Applicant citing Non-patent literature citation No. 5, Yamanaka et al., Development of a novel β-1,6glucan-specific detection system using functionally-modified recombinant endo-β-1,6-glucanase, J. Biol. Chem., 295(16), (2020), p. 5362-5367 (cited previously) (see each of Applicant’s examples refers to this species of the genus).
Regarding disclosure of the structural features of this particular species of mutant, see for example Yamanaka, who report that the probe is developed by modifying Neurospora endo-β-1,6-glucanase Neg1, namely plasmids encoding the mature form of the Neg1 protein with point mutations at the catalytic positions, i.e., Glu-225, Glu321 or both) to glutamine were generated, the recombinant Neg1 and its variants were efficiently expressed in E. coli (Yamanaka, page5363, col. 2, para 1). The Neg1-E225Q, NEG1-E321Q and Neg1-E225Q/E321Q mutants were then screened to evaluate whether the glucan binding activity was preserved in Neg1 with the different point mutations. See at page 5363, col. 2, paras 3 and 4, Neg1-E321Q showed increased binding activity. Applicant’s actual reduction to practice refers only to the species having the structure comprising the point mutation E[Wingdings font/0xE0]Q a position 321.
Other than the species indicated in Yamanaka et al., it is not clear or predictable, what other point mutations/ β-1,6-glucanase mutants would exhibit the claimed functional abilities (bind and have no cleavage activity while retaining specific binding activity to a β-1,6-glucan).
The level of skill and knowledge in the assay art regarding the detection/quantification of branched glucan structures is high. It is not readily predictable what other species of β-1,6-glucanase mutants binding protein exhibit the recited functional ability, one having ordinary skill in the art cannot readily visualize what species of the claimed genus of β-1,6-glucanase mutants are encompassed by the claimed invention. Applicant’s originally filed specification only appears to support possession of the singular claimed species.
Regarding the predictability in the prior art, other than that species disclosed in the prior art by Yamanaka et al., it is not predictable what other species achieved the desired functional ability, or even if other species having only mutations at the catalytic domain (like the single species disclosed by Applicant) would also meet the functional requirements of the claim (bind but not exhibit cleavage activity).
There is no disclosed correlation between function and structure, such that one having ordinary skill can readily predict or visualize what structural mutants would be capable of the claimed function (i.e., in terms of what residue positions can tolerate mutation such to retain binding, but not exhibit cleavage activity).
For all of these reasons, the written description fails to support Applicant was in possession of all possible mutants encompassed by the claimed genus.
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 1-5 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.
Claims 1 and 4 recite reagent (A) “consists of a first fusion protein having a split reporter protein”, however then the claim further recites “the first fusion protein includes a β-1,3-glucan binding protein and one of the split reporter proteins”. As a result, the recited language is indefinite because the first citation indicates reagent (A) consists of (is limited to) the first fusion protein and a split reporter protein, however, the later recited language suggest that first part of the reagent (A), the fusion protein, includes a β-1,3-glucan binding protein and a split reporter protein. This would suggest that reagent (A) is β-1,3-glucan binding protein and a split reporter protein, and another split reporter protein, rather than merely a β-1,3-glucan binding protein and a first split reporter protein.
Further, the language at claim 1 (and also claim 4), “one of the split reporter proteins” is indefinite because it is unclear which “split reporter protein” the claim is in reference to, since the claim previously recites three different instances of “a split reporter protein” (the one with the first fusion protein, the one with the second fusion, as recited at (A), and the “split reporter protein” recited at reagent (B)).
Claim 1 recites at lines each of 14-15, 16-17, 19 and 23 “the other of the split reporter proteins”, however, the claim does not previously or clearly refer to any one “split reporter protein” as a first or an “other” split reporter protein (see also, the language recited in claim 4). The language is indefinite because it is unclear exactly which split reporter protein each instance of this language is in reference to (see previously “split reporter” is referenced multiple times).
The claim recites “the split reporter protein is capable of forming an active reporter protein by making a pair of separated two of the split reporter proteins”, however, it is not clear which two split reporter proteins are part of the same pair that make an active reporter protein.
Response to Arguments
Applicant's arguments filed 10/24/2026 have been fully considered but they are not persuasive for the following reasons.
Regarding the previous objection to the drawings (remarks pages 6-7), see as indicated in detail above, the previous objection is withdrawn in response to Applicant’s amendments to the claims.
The previous prior art rejections under 35 U.S.C. 102 and 35 U.S.C. 103 are withdrawn in response to Applicant’s amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677