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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 12/21/23 and 6/10/25 have been fully considered except where references have been lined through
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.
Regarding claims 1-12, claim 1 (b) requires one or several substitutions to SEQ ID NO 1 while retaining the laccase activity at alkaline pH and/or 87% or more sequence identity to SEQ ID 1. To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus (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 (Id.). A “representative number of species” means that the species which are adequately described are representative of the entire genus (Id.). The specification describes SEQ ID NO 1 as the only species of the claimed genus. Other laccases of SEQ ID NO 1 could comprise any number of several substitutions or additions or deletions or insertions along the 614 amino acids of SEQ ID NO 1. As evidenced by Xue, there are over 800 naturally occurring amino acids and 1000s of unnatural amino acids (introduction). Therefore, one of ordinary skill in the arts understands that there is a nearly unlimited number of members in the genus of one or several substitutions to SEQ ID NO 1. While the specification suggests that the positions 136, 138, 181, 183, 474, 477, 479, 545, 546, 547, and 551 are important to function, there is no experimental support for specific substitutions at those positions or for any associated domain/structure contributions that the claimed positions contribute to the functionality of the laccase at alkaline pH. Additionally, there is no discussion in the specification as to how additional amino acids would alter/maintain the activity of the enzyme. As such, the specification fails to describe a representative number of species that would evidence possession of the full scope of several substitutions to SEQ ID NO 1 that maintain the laccase activity at alkaline pH.
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 1-12 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.
Regarding claim 1, claim 1(b) requires “several amino acids”. While the specification [0046] suggests that 1-10 amino acids is preferable, this is a suggestion and not a concrete definition of “several”. People of ordinary skill in the arts have different definitions of how many amino acids is “several”. Therefore, the metes and bounds of the claims cannot be determined and the claims are indefinite.
Regarding claim 1, claim 1(b) and (c) require “having a laccase activity equivalent to the that of the polypeptide shown in the above (a). Claim 1 (a) does not define the activity level of SEQ ID NO 1. One of ordinary skill in the arts understands that the activity of an enzyme is influenced by many variables including temperature, concentration of enzyme and substrates, pH conditions, and purity level of the enzyme among other variables. A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See MPEP 2173.05(b). Moreover, the term "equivalent" can be considered a term of degree which renders the claim indefinite. The term 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. It is thus unclear what type and/or level of difference would be allowable under the scope of the term "equivalent".
Claims 7-8 recite an enzyme preparation of claim 6, wherein the enzyme preparation is used in a recited manner. A claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b), as it is unclear how the recited use limits the structure of the product (MPEP 2173.05(p), II.).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 6 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite a polypeptide, a DNA encoding the polypeptide, an enzyme preparation, and allowing the laccase to act on a protein respectively. This judicial exception is not integrated into a practical application because there are no elements beyond the naturally occurring laccase and the natural DNA encoding for the laccase. The enzyme preparation and the method of allowing the laccase to act on a protein do not comprise any specific components/steps that are different from what is naturally occurring as other proteins would naturally occur with expression of the laccase by the microbe. Therefore, no additional elements are present that renders the claimed process markedly different from the natural product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any
statutory category. MPEP 2106.03. The claims recite a polypeptide, a DNA encoding the polypeptide, an enzyme preparation, and allowing the laccase to act on a protein respectively. Thus, the claim is to a product, which is one of the statutory categories of invention. As discussed above, the method claim does not have any additional elements to render it different from the natural product alone.
(Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim
recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019
Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or
“described” in the claim. No extra elements are present in claims 1-2, and 6. In addition, the limitation in claim 9 allowing the laccase to act on a protein does not provide any details on how to do this and therefore does not structurally limit the claims beyond the product of nature as other proteins would be co-expressed with the laccase in the microbe in its natural environment. Accordingly, the claims recites a judicial exception (natural product, and a process recited at such a high level of generality as to be equivalent to the product). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong
Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating
those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application. 2019 PEG Section
III(A)(2), 84 Fed. Reg. at 54-55. The claimed product and method step does not require any additional elements that render the claimed product markedly different from the natural
counterpart. No extra elements are present in claims 1-2, and 6. The limitation of allowing the laccase to act on a protein does not provide any details on how to do this and therefore does not structurally limit the claims beyond the product of nature. Accordingly, the limitations laid out in claims 1-2, 6 and 9 do not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception. See MPEP 2106.05(h), discussing the administration step in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78
(2012) (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole
amounts to significantly more than the recited exception, i.e., whether any additional
element, or combination of additional elements, adds an inventive concept to the claim.
MPEP 2106.05. No extra elements are present in claims 1-2, and 6. As discussed with Step 2A prong 2, the addition of the intended step of allowing the laccase to act on a protein is at best the equivalent of merely adding the words “apply it” as the claimed process does not require any additional elements that are sufficient to amount to
significantly more than the judicial exception. Mere instructions to apply an exception cannot
provide an inventive concept (Step 2B: NO).
Claims 1-2, 6 and 9 are not eligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657