DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 12, 2025, has been entered.
Claim Disposition
3. Claims 5-6, 10-11, 24 and 26-27 have been cancelled. Claims 1-4, 7-9, 12-23, 25 and 28-30 are pending. Claims 1-4, 12-16, 23 and 28-30 are under examination. Claims 7-9, 17-22 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim objection
4. Claims 1-4, 12-16, 23 and 28-30 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “…..SEQ ID NO: 1 [[further comprising]] with one or more mutations…..”. The dependent claims hereto are also included.
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.
5. Claims 1-4, 12-16, 23 and 28-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention is directed to a transglutaminase enzyme comprising the amino acid sequence of SEQ ID NO:1 further comprising one or more mutations selected from the group recited in claim 1. The claimed invention can be construed as the variations are already in SEQ ID NO:1 and then it is further mutated with the list provided,. However the claimed invention is not commensurate in scope with the specification because it is disclosed that SEQ ID NO: 1 is the wildtype. In addition, the claimed invention encompasses the transglutaminase variant in combination with one or more antimicrobial enzyme, peptide, or protein (see claim 23), wherein the composition comprises preservative, biocidal, antimicrobial or virucidal activity (see also claim 30 with similar language). The invention as claimed is not adequately described because there are no indicia in the claim of how does any peptide or protein with a transglutaminase variant functions as preservative, biocidal, antimicrobial or virucidal activity. The art discloses generally that one such antimicrobial enzyme is lysozyme to produce robust food, safe active packaging films, however, the claimed invention is not limited to this. Moreover, it is generally acknowledged that transglutaminase forms bonds between glutamine and lysine (essential), however, not all proteins have these amino acids, yet the claimed invention is broadly directed to any protein. In addition, the claimed composition is recited as having so many varied activity such as preservative, biocidal, antimicrobial or virucidal, thus the components of the composition needs to be adequately described. The invention is also overly broad with the recitation of “one or more biocidal chemicals” in claim 28 because and this encompasses a large variable genus of chemicals and there are no indicia as to the relationship of this with claim 1 and would more properly suit claim 23. Furthermore, claim 29 recites broadly a polymer, detergent, base, organic acid, for example, which are not adequately described.
The specification fails to provide a representative number of species for the claimed genus to show that 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.
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
6. Claims 1-4, 12-16, 23 and 28-30 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 and the dependent claims hereto are indefinite for the recitation of “a variant” and “further comprising one or more mutations selected from….”. The claim lacks clarity because SEQ ID NO:1 is the wild-type thus the variant aligned with SEQ ID NO:1 but comprises the one or more mutations in the list; but the claim language can be construed as SEQ ID NO:1 being the variant with the additional mutations.
Clarification is needed. The dependent claims hereto are also included.
Response to Arguments
7. Applicant’s comments have been considered. Withdrawn objections/rejections will not be discussed herein applicant’s comments are moot. Note that new rejections have been instituted based on amendments made to the claims for the reasons stated above. Several attempts were made to reach applicant’s representative to reduce the remaining issues. Applicant is urged to contact the examiner.
Conclusion
8. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652