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 1-8, and the species of JaPAL in the reply filed on 05/22/2026 is acknowledged.
Claim Status
The response of 05/22/2026 has been entered. Claims 1-22 are pending in this US patent application. Claims 9-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/22/2026.
Claims 1-8 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 03/28/2024 have been received and considered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 contains the abbreviation TAL without defining the meaning of this abbreviation.
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.
Claims 1-8 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 enzymes produced and tested in the specification (e.g., SEQ ID NOs: 145 and 146), does not reasonably provide enablement for the full scope of claim 1, which encompasses any PAL enzyme with any number of mutations of any type (addition, substitution, deletion, etc.) relative to the wild-type PAL as long as said PAL enzyme also contains a mutation at a position corresponding to position 112 of SEQ ID NO: 28 and exhibits the particular function of having increased TAL activity relative to the wild-type PAL enzyme. 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 PAL enzyme that contains 1) a mutation at the position corresponding to position 112 of SEQ ID NO: 28, 2) any number of other mutations of any scope, and 3) the function of increased TAL activity relative to the wild-type PAL. The instant claims limit the wild-type PAL and the required mutation but do not limit the engineered PAL other than the particular location of the required mutation and the recited function. Thus, the claims taken together with the specification imply that the scope of the invention encompasses any PAL enzyme that contains 1) a mutation at the position corresponding to position 112 of SEQ ID NO: 28, 2) any number of other mutations of any scope, and 3) the function of increased TAL activity relative to the wild-type PAL.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The function of an enzyme is well-known in the art to be strongly linked to the structure of the enzyme, which is largely determined by its primary sequence. For example, Louie (Louie et al., Chem. Biol. 13: 1327-1338 (2006)) teaches the alteration of a single amino acid in an ammonia lyase that switches its substrate specificity from tyrosine to phenylalanine. As such, the state of the prior art at the time of Applicant’s invention indicates that mutating an enzyme to any degree while maintaining its activity and improving its activity related to the wild-type variant 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 has provided specific examples of PAL enzymes that contain highly specific point mutations at highly specific locations of the sequence but maintain high levels of sequence identity with the wild-type enzyme. Applicant has provided no examples of being able to improve the TAL activity of a PAL enzyme while making the drastic mutations that fall within the scope of the instant claims.
(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 determine the variants that improve the TAL activity of a PAL enzyme relative to its wild-type within the vast scope of the mutations encompassed within the instant claims.
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 the generation of enzymatic function, that, while the specific examples provided in the instant specification are enabled, the broad scope of the instant claims is not enabled.
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.
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, 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.
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.
/Erin M. Bowers/Primary Examiner, Art Unit 1653 08/13/2026
Prosecution Insights