DETAILED ACTION
Notice of 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 with traverse of the species renewable feedstock in the reply filed on 10 July 2026 is acknowledged. The traversal is on the ground(s) that the source of L-phenylalanine does not fundamentally change the PAL-mediated conversion of L-phenylalanine and the Fdc1-medicated conversion of trans-cinnamic acid to styrene. Upon consideration of Applicant’s arguments, the Examiner agrees, and the election of species requirement is therefore withdrawn.
Status of Application
Claims 1-12 are pending and subject to examination on the merits.
Priority
The instant application is a 371 of PCT/US2023/063547 filed 02 March 2023 which claims benefit of foreign priority document EP22160036.4 filed 03 March 2022 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09 October 2024 been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Objections
Claim 1 is objected to because of the following informalities: the first time an acronym is utilized in a claim set, it should be spelled followed by the acronym in parenthesis (e.g. phenylalanine ammonia-lyase (PAL); ferulic acid decarboxylase (Fdc1). 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 1-12 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: A process for producing styrene, the process comprising the steps of: providing a source of L-phenylalanine to a vessel; adding a first biocatalyst comprising a PAL enzyme to the vessel, the first biocatalyst provided in a form selected from PAL-containing whole-cell pellets, a suspension of PAL- containing whole-cell pellets, a suspension of PAL-containing whole cells derived from PAL-containing whole-cell pellets, and combinations thereof; adding a second biocatalyst comprising a Fdc 1 enzyme to the vessel, the second biocatalyst provided in a form selected from Fdcl-containing whole-cell pellets, a suspension ofFdcl- containing whole-cell pellets, a suspension of Fdcl-containing whole cells derived from whole-cell pellets, and combinations thereof; and producing styrene by converting the L-phenylalanine to trans-cinnamic acid with the first biocatalyst and converting the trans-cinnamic acid to styrene with the second biocatalyst, wherein the first biocatalyst is not the same as the second biocatalyst and wherein the reaction takes place a pH between 6-8 and a temperature between 0-60oC, does not reasonably provide enablement for: A process for producing styrene, the process comprising the steps of: providing a source of L-phenylalanine to a vessel; adding a first biocatalyst comprising a PAL enzyme to the vessel, the first biocatalyst provided in a form selected from PAL-containing whole-cell pellets, a suspension of PAL- containing whole-cell pellets, a suspension of PAL-containing whole cells derived from PAL-containing whole-cell pellets, and combinations thereof; adding a second biocatalyst comprising a Fdc 1 enzyme to the vessel, the second biocatalyst provided in a form selected from Fdcl-containing whole-cell pellets, a suspension of Fdcl- containing whole-cell pellets, a suspension of Fdcl-containing whole cells derived from whole-cell pellets, and combinations thereof; and producing styrene by converting the L-phenylalanine to trans-cinnamic acid with the first biocatalyst and converting the trans-cinnamic acid to styrene with the second biocatalyst, wherein any condition is utilized and wherein the first and second biocatalyst are the same. 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 and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 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 USPQ2d 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). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
In the instant case, the amount of direction and guidance presented in the specification, by way explanation and working examples, are drawn to specifically utilizing two different whole cell biocatalysts, the first comprising a phenylalanine ammonia lyase (PAL) and the second, different whole cell biocatalyst comprising a ferulic acid decarboxylase Fdc1 (but not PAL) – and wherein the whole cells are in a non-growth/resting phase, and wherein the conditions to produce styrene from L-phenylalanine occurs a pH of 6-8 and temperatures between 20-40oC (although temperatures outside this range are conceivable, albeit slower). However, despite there being many examples of cells utilizing co-expressed PAL and Fdc1 (See Liu et al., 2018; Marshall et al., 2017 and McKenna et al., 2011 – all cited on IDS), there is no prior art which utilize non-growing/resting whole cells, one set comprising PAL and another set comprising Fdc1, that are pelletized and utilized for converting L-phenylalanine to styrene, and thus the conditions for such a method are also not known. While the skill in the art is relatively high, the determination of enablement (or scope of enablement) is the necessity for the skilled artisan to have to practice undue experimentation. Here it would be required given the scope of the claims includes any conditions for the process to take place and it could be interpreted that the first and second biocatalyst comprise the same enzymes (e.g. they are one and the same).
As such, the breadth of claims exceed that which is enabled because the amount of direction and guidance in the specification and working examples coupled with what is known in the art suggests that the instant method claims will be highly unpredictable thus leading one skilled in the art to a huge amount of undue experimentation, despite the high level of skill of said artisan.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 09 September 2026
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