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 .
The Response of 13 March 2026 has been entered.
Claims 9-11 and 13 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group VII in the reply filed on 13 March 2026 is acknowledged.
Claim Rejections - 35 USC § 112(a) (written description)
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.
Claims 9-11 and 13 are rejected under 35 U.S.C. 112(a) 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 instant claims recite a method for crosslinking a protein comprising a step of allowing a laccase to act on a protein, wherein the laccase comprises: a) SEQ ID 1; b) a polypeptide with one or several substitutions, insertions, deletions or additions to SEQ ID 1 and having laccase activity equivalent to that of SEQ ID 1 in a pH range including the alkaline range; or c) a polypeptide having 70% or more identity to SEQ ID 1 and having laccase activity equivalent to that of SEQ ID 1 in a pH range including the alkaline range. The specification states that the laccase activity includes protein crosslinking activity and is measured under specific conditions (Published Spec. US20240287475, [0054]-[0055]). The specification also states that an equivalent laccase activity is when "the amount of a crosslinked protein produced by an action of the polypeptides of (b) and (c) is 80 to 120% of the amount of a crosslinked protein produced by" SEQ ID 1 (Spec., [0056]). SEQ ID 1 is a protein of 587 amino acids, such that the 70% identity limitation encompasses a genus of polypeptides having up to 176 amino acid differences from SEQ ID 1. Since the equivalent activity is defined broadly to include 80-120% of the activity of SEQ ID 1 at any pH within the alkaline range (defined as >8.5; Spec., [0053]), the claims encompass a large and varied genus of potential polypeptide that would include enzymes having substantially different activity than the disclosed species of SEQ ID 1 (e.g., activity at different pH within the alkaline range and/or greater activity than SEQ ID 1).
To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus, which in the case of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species 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 (MPEP 2163).
The instant specification discloses only the sequence of SEQ ID 1 (Spec., [0129]), and does not provide any additional examples other than SEQ ID 1 that could be considered a representative number of species supporting the claimed genus. The specification further states that "amino acids at positions 126, 128, 166, 168, 429, 432, 434, 484, 485, 486, 490, and 495 in the amino acid sequence shown in SEQ ID NO: 1 are considered to contribute to activity, and thus it is desirable not to introduce substitutions or deletions into these sites" (Spec., [0049]). However, the claims do not restrict substitutions, additions, deletions, etc. to any specific site within the sequence, and the specification fails to provide any structure-function relationship or other teachings/guidance that would allow one of ordinary skill to identify specific variants within the claimed genus (e.g., which portions of the sequence are responsible for the claimed functionality and/or what types of modifications would lead to such functionality). Yin et al., Amb Express 9.1 (2019): 151 (cited in IDS of 6 Aug. 2025) evidences that mutation at only three residues is sufficient to significantly alter the alkaline activity level of a fungal laccase, and that such mutations can include both highly conserved and variable sites at different domains within the sequence (p. 4, last ¶ to p. 7, last ¶). Thus, mutations corresponding to alkaline activity levels of fungal laccases are not predictable based on the general knowledge in the art, such as identifying conserved regions via sequence alignments and the like. The instant specification therefore does not evidence possession of the claimed laccase variants of SEQ ID 1 having equivalent activity within the alkaline range over the entire scope of the claimed genus (see also, MPEP 2163 - A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed).
Claim Rejections - 35 USC § 112(b) (indefiniteness)
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.
Claims 9-11 and 13 are rejected under 35 U.S.C. 112(b) 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 9 recites "a polypeptide comprising an amino acid sequence in which one or several amino acids are substituted, added, inserted, or deleted in the amino acid sequence shown in SEQ ID NO: 1". The ordinary meaning of the term "several" is more than two and fewer than many (e.g., definition at https://www.merriam-webster.com/dictionary/several). The term "several" is thus inherently indefinite. The specification states that "the number of amino acids to be substituted, added, inserted, or deleted may be 1 or more or several, and is, for example, 1 to 10, preferably 1 to 8, 1 to 6, 1 to 5, or 1 to 4, more preferably 1 to 3, and particularly preferably 1 or 2 or 1" (Published Spec. US20240287475, [0046]). The above recitation of specific numbers of amino acids are preferences that do not provide a limiting definition. The rejection can be overcome by amending to recite a specific number, e.g. 1-10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
Prosecution Insights