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 the invention of Group I, claims 1-2, 5-6, 31-36, 46, 49-50, and 57-58, and the species of SEQ ID NO: 3 in the reply filed on 06/03/2026 is acknowledged.
Claim Status
The amendment of 06/03/2026 has been entered. Claims 1-2, 5-6, 31-36, 46, 49-50, 57-58, 66-67, 70-71, and 74 are pending in this US patent application. Claims 66-67, 70-71, and 74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 36, 46, and 49-50 are withdrawn as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/03/2026.
Claims 1-2, 5-6, 31-35, and 57-58 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 04/15/2024 has been received and considered.
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 1-2, 5-6, 31-35, and 57-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the specific, defined glucoamylase sequences recited in the specification, does not reasonably provide enablement for any sequence or variant with any level of sequence identity to SEQ ID NO: 4, at least one amino acid substitution in at least one of the positions recited in instant claim 1, and glucoamylase activity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
As discussed above, the claims are drawn to any sequence or variant with any level of sequence identity to SEQ ID NO: 4, at least one amino acid substitution in at least one of the positions recited in instant claim 1, and glucoamylase activity. Thus, the claims taken together with the specification imply that the full breadth of the instant claims incorporates any sequence or variant with any level of sequence identity to SEQ ID NO: 4, at least one amino acid substitution in at least one of the positions recited in instant claim 1, and glucoamylase activity.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The relationship between an enzyme’s structure, which is determined by its amino acid sequence, and its activity is well-established in the prior art, and engineering a particular activity de novo into a protein sequence is beyond current technology.
As such, the state of the prior art at the time of Applicant’s invention indicates that an understanding of the entire range of protein sequences with any level of divergence from SEQ ID NO: 4 that exhibit glucoamylase activity was highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
Applicant’s specification has provided a handful of highly specific, fully defined protein sequences that exhibit glucoamylase activity. Applicant’s disclosure does not provide a full understanding of every sequence that could possibly result in glucoamylase activity or a means to obtain said understanding.
(8) The quantity of experimentation necessary:
Considering the state of the art, the high unpredictability, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to make the full range of all sequences that fall within the broad scope of instant claim 1 and exhibit glucoamylase activity.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation. It is also noted, considering the a priori unpredictability in the art with regard to enzyme structure/function relationships, that, while particular sequences (e.g., SEQ ID NO: 3) are enabled, the full scope of claim 1 is not enabled.
Election/Restrictions
Applicant’s elected species of glucoamylase, SEQ ID NO: 3, is free of the prior art. The closest prior art to the claimed invention is found in Poynter, as discussed below. However, Poynter does not teach or suggest the specific, defined sequence of SEQ ID NO: 3. As such, the Examiner has selected another species that falls within the scope of instant claim 1, a glucoamylase with 68.62% identity with instant SEQ ID NO.: 4 that has substitutions at positions 20, 37, 66, 73, 79, 81, 119, 140, and 156, for examination with respect to the prior art. In light of the Examiner’s selection, claims 2, 5-6, 31-36, 46, and 49-50 are withdrawn from examination with respect to the prior art as being drawn to nonelected species.
Claims 1 and 57-58 are currently under examination with respect to the prior art and were examined on their merits.
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.
Claims 1 and 57-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by international patent application publication WO 2019/191263 filed by Poynter et al., published 10/03/2019 (cited on the IDS filed 04/15/2024).
Poynter teaches SEQ ID NO.: 39, which has 68.62% identity with instant SEQ ID NO.: 4 and has substitutions at positions 20, 37, 66, 73, 79, 81, 119, 140, and 156, among others (see entire document, including Poynter SEQ ID NO.: 39; reads on claims 1 and 57-58; the Examiner notes that any sequence may be interpreted as an “enzyme composition” as recited in instant claim 57 and that a composition, which is defined by its structure, cannot be limited by any particular “use” of said composition [cf. instant claim 58]).
Therefore, claims 1 and 57-58 are anticipated by Poynter and are rejected under 35 U.S.C. 102(a)(1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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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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/Erin M. Bowers/Primary Examiner, Art Unit 1653 08/19/2026
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