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 .
DETAILED ACTION
The instant application is a U.S. national phase of PCT/KR2020/003061 filed on March 4, 2020 and has a foreign application KR10-2019-0026633 filed on March 8, 2019. Applicant’s amendment filed March 12, 2026 is acknowledged. Claims 1-4, 6-10, 20, and 23-27 are canceled, and claims 5, 22, 28, and 31-32 are amended. Currently claims 5, 11-19, 21-22, and 28-32 are pending and under examination.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 12, 2026 has been entered.
Claim Objections
Claims 5 and 32 are objected to because of the following informalities:
Claim 5, line 16, should recite “…the recovering converted allulose” to maintain claim language consistency.
Claim 32, line 2, needs to be changed to “…rate is a measurement of the…” for a typographical error.
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 5, 11-19, 21-22, and 28-32 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 method for preparing allulose by contacting the specific strains of Staphylococcus species listed in Table 1 of the specification with fructose to convert fructose to allulose at a temperature of 50⁰C to 70⁰C, does not reasonably provide enablement for a method of preparing allulose by contacting any other strain of the wild-type Staphylococcus species recited in the claims with fructose to convert allulose at a temperature of 50⁰C to 70⁰C. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claims:
Claims 5, 11-19, 21-22, and 28-32 are drawn to a method for preparing allulose by contacting any of the wild-type Staphylococcus species recited in the claims with fructose at a temperature of 50⁰C to 70⁰C for any amount of time, and recovering said allulose by crushing the microorganism, centrifugation, filtration, ion-exchange chromatography, or crystallization.
The nature of the invention:
The nature of the invention relies upon any of the recited wild-type Staphylococcus species growing/culturing at the specified temperature of 50⁰C to 70⁰C to naturally metabolically convert fructose to allulose, and recovering said allulose.
The state of the prior art:
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating any of the recited Staphylococcus species metabolically growing at the recited temperatures is contraindicative, and the prior art is lacking on demonstrating on whether the full scope of the recited species can produce allulose as recited in the method. As disclosed by Montanari et al. (Food Control 50 (2015) 605-612), Staphylococci grow over a wide range of temperatures (between 7 and 48 ⁰C) and pH values (between 4 and 10), and are particularly resistant to NaCl (pg. 606, col. 1, para 2). Montanari et al. teaches multiple strains of Staphylococcus epidermidis, Staphylococcus lugdunensis, and Staphylococcus aureus were grown in variable culture conditions to determine thermal resistance, and assessed thermal death kinetic, as well as effects of pre-culture conditions on the thermal resistance (pg. 606-08, sec. 2.1, 3.2, 3.3). Montanari et al. found increasing NaCl concentration markedly affected the susceptibility to the thermal treatment of S.aureus SS3 and, to a lesser extent, of two strains isolated from tofu (S. epidermidis VR and S. lugdunensis CB5), on the other hand, data showed pre-culture of staphylococcal strains under stressing conditions did not induce a modification of thermal resistance in all type strains and in a wild strain, and points out the presence of a stress factor can lower the thermal resistance of the strains belonging to the same species (pg. 608-09, sec. 3.3).
Recommended minimal standards for description of new staphylococcal species by Freney et al. (International Journal of Systematic Bacteriology (1999), 49,489-502), indicate the species S. equorum, S. lentus, and S. muscae did not grow at 45 ⁰C, and likewise the species S. chromogenes and S. xylosus had weak to negative growth; and when grown on NaCl agar 15% (w/v) the species S. epidermidis and S. saprophyticus did not grow, and likewise the species S. chromogenes, S. lentus, and S. warneri had weak to negative growth (pg. 494-95, Table 2), thus underlining Staphylococcus species’ growth variability in higher temperatures and higher salt concentrations.
Thus a review of the prior art does not find support that all strains within a species of the genus Staphylococcus will grow and be metabolically active under the recited temperature range to naturally convert fructose to allulose as claimed.
The level of one of ordinary skill and predictability in the art:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that methods for preparing allulose by contacting any wild-type strain of the recited Staphylococcus species with fructose at a temperature of 50 ⁰C to 70 ⁰C to naturally convert fructose to allulose, one of ordinary skill in the art would look for guidance or direction in the instant specification.
“The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03). In the instant case, the various strains that fall within the scope of the recited species would require different culture/conversion methods. Given what is known in the art about the genus of Staphylococcus, it is a mesophilic bacteria that thrives at temperatures around 37 ⁰C, whereas the thermal death point is typically between 50 ⁰C to 65 ⁰C, as evidenced by Shrestha (Microbe Notes <https://microbenotes.com/mesophiles/>, 3/8/2024).
The amount of direction provided by the inventor and existence of working examples:
The instant application describes confirming allulose production by 32 strains of various Staphylococcus species in Table 1, ranging from a conversion rate of 29.8%-0.3%. Each strain was inoculated in TSB to which allulose was added at 1% and cultured at 30 ⁰C or 37 ⁰C for 18 hours, then washed with NaCl and the whole-cell conversion reaction. Potassium phosphate buffer (50 mM, pH 7.5) was added to the washed strain at 20% (w/w), and then fructose was added at 1% (w/w), then the conversion reaction occurred at 55 ⁰C for 12 hours (pg. 17). The supernatants were then recovered and subjected to HPLC analysis to confirm allulose production.
The working embodiments do not describe any other strains except the species listed, and do not describe alternative methods based on optimal conversion reactions dependent on species/strains. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role of all strains of the recited species plays in allulose production at a conversion temperature of 50 ⁰C to 70 ⁰C, and given the broad scope of the claims and the different culture methods encompassed, it is unpredictable if using any strain of the recited species in various culture methods would predictably produce allulose as claimed. The specification does not provide sufficient guidance on culturing and conversion conditions to enable allulose production of the full scope of all strains that belong to the recited Staphylococcus species. Rather the specification described an example of a generic culture/conversion method with the specific strains disclosed in Table 1 and their resulting conversion rates of allulose. The prior art also does not provide additional guidance to enable methods of converting fructose to allulose with any type of strain of the recited Staphylococcus species of the full scope of the claims.
Therefore, due to the unpredictability in the art with respect to the unpredictability of biological systems (especially among strains of the same Staphylococcus species) and the well-established mesophilic nature of Staphylococcus species, it would be unpredictable that converting fructose to allulose at a high temperature (50 ⁰C to 70 ⁰C) with any strain of the full scope of the recited Staphylococcus species would reasonably occur, thus one would have to engage in experimentation that is not reasonable in order to determine which of the various strains could be cultured and used to convert fructose to allulose with the claimed method.
Without further guidance, one of skill in the art would have to practice a substantial amount of trial-and-error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed March 12, 2026, with respect to claims 9, 12-14, 18-21, and 29-32 have been fully considered and are persuasive. The 103 rejection of claims 9, 12-14, 18-21, and 29-32 has been withdrawn.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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