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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/06/2025 has been entered.
Priority
This application is a 371 of PCT/KR2021/003850 filed 03/29/2021. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on KR10-2021-0008188 filed 01/20/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1 and 3-14 are pending. Claims 1 and 3 are amended. Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/20/2024.
Claims 1 and 3-12 (claim set filed 05/06/2025) and are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 05/06/2025 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
The previous claims 1, 3, 4 and 7-12 rejection under 35 U.S.C. 102 (a) (1) (a) (2) has been withdrawn necessitated by amendment of claims 1 and 3.
The previous claims 1, 5 and 6 rejection under 35 U.S.C. 103 has been withdrawn necessitated by amendment of claim 1.
Claim Interpretation
Claim 1 is interpreted under the broadest reasonable interpretation in light of the specification.
Claim 1 is interpreted as directed to a composition comprising a reactivator comprising L-ornithine and excluding arginine, aspartic acid, and proline. The phrase: “for reactivation of lyophilized probiotics” is interpreted as intended use of the composition. The recitation of intended use is given weight to the extent that it imparts a structural limitation and the prior art needs to be capable of performing the intended use. (MPEP 2111.02). The phrase: “confers a negative zeta-potential on cell surfaces of the probiotics at pH 2.5 to reactivate the lyophilized probiotics” is interpreted as functional property which is the inherited property of the composition. The wherein clause: “the composition improves intestinal survivability of lyophilized probiotics” is interpreted as functional property which is the inherited property of the composition not imparting the structure, i.e. the composition comprising L-ornithine.
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, 3-6 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The claim 1 recites a composition comprising reactivator comprising L-ornithine. The L-ornithine is a natural product. Claim 1 does not indicate modification of L-ornithine. Note the isolation or purification of a naturally occurring product does not make it eligible.
This judicial exception is not integrated into a practical application because in addition to L-ornithine claim 1 recites the intended use of the composition, i.e. reactivation of lyophilized probiotics and the inherited functional properties, i.e. to confer a negative zeta-potential on cell surfaces of the probiotics at pH 2.5 to reactivate the lyophilized probiotics and to improve intestinal survivability of lyophilized probiotics as described in the claim interpretation above. Claim 1 does not recite any additional components besides L-ornithine in the composition and excludes arginine, aspartic acid and proline from the composition. The intended use and functional properties add insignificant extra solution description to the judicial exception.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the intended use and the inherited properties do not impart the structure, i.e. the composition, and hence do not alter the judicial exception.
Based on the above claim 1 is rejected as ineligible.
Dependent claim 3 is directed to additional components in the composition, L-lysine, L-tyrosine and L-histidine, which are natural amino acids. Claim 5 is directed to naturally occurring carbohydrates. The naturally occurring products of claims 3 and 5 represent judicial exceptions and do not alter the judicial exception of L-ornithine. Claim 4 is directed to concentrations of the reactivator, L-ornithine, when dissolved in a solvent that do not change the properties of L-ornithine. Claim 6 is directed to concentration of the carbohydrates in the composition that do not change the properties of carbohydrates. Claim 10 is directed to dissolving the composition in a solvent to reactivate the lyophilized probiotics before intake. The dissolving the composition in a solvent to reactivate the lyophilized probiotics before intake is the intended use of the composition and is inherent to the composition and hence that does not impart the structure, i.e. composition, and does not alter the judicial exception. The limitations of claims 3-6 and 10 are recited at high level of generality and are not sufficient to amount to significantly more than the judicial exceptions because they do not impart a structural limitation and do not alter the judicial exception or make it markedly different. Therefore, claims 3-6 and 10 are rejected as ineligible.
Based on the above claims 1, 3-6 and 10 are rejected as directed to ineligible subject matter.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4 and 10-12 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Fujimori (JP 2003219862).
Regarding claim 1, Fujimori teaches a method to improve the storage stability of a freeze-dried (which is lyophilized) bacterium and storage stability improver composition (Abstract). In one embodiment the storage stability improver for freeze-dried microorganisms contains ornithine or serine or a salt thereof (paragraph 0005). Fujimori describes that the storage stability improver is mixed with the microorganism (paragraph 0009) and can be added before or after the freeze-drying treatment (paragraph 00011). Example 1 describes mixing the aqueous solution of each of 20 amino acids, including ornithine, with Bifidobacterium longum ATCC15707 cells collected after culturing (paragraph 0013). The resulting suspension was freeze-dried and the viability of cells was measured after storage for 2 days and compared to that before freeze-drying (paragraph 0015). The ornithine hydrochloride improver composition showed high survival rate (paragraph 0016). Thus, Fujimori teaches composition, comprising ornithine and not comprising arginine, aspartic acid or proline that is used for reactivation of lyophilized probiotics.
As described in the claim interpretation above, conferring a negative zeta-potential on cell surfaces of the probiotics at pH 2.5 and improving intestinal survivability of lyophilized probiotics is interpreted as functional property which is the inherited property of the composition not imparting the structure, i.e. the composition. Since Fujimori teaches the same composition as claimed, it would inherently have the same functional properties as in instant claim. Thus, Fujimori teaching anticipates claim 1.
Regarding claim 4, Fujimori teaches addition of 2% (w/v) aqueous solution of ornithine in Example 1 which, considering molecular weight of ornithine of 132, will result in 0.15 M final concentration. Thus, Fujimori teaching anticipates claim 4.
Regarding claim 10, Fujimori teaches that the composition of ornithine can be in the form of a solution in the aqueous medium used to suspend the microorganism (paragraph 0009) and that it can be added before or after the freeze-drying treatment (paragraph 00011). Dissolving the composition in a solvent to reactivate the lyophilized probiotics before intake is interpreted as intended use of the composition. Since Fujimori teaches the same composition as claimed and therefore, the composition has the same structure, and the composition can be added to lyophilized probiotics in a solvent, it would inherently be capable of reactivating lyophilized probiotics before intake. Thus, Fujimori teaching anticipates claim 10.
Regarding claims 11 and 12, Fujimori describes the lyophilized probiotic product comprising the claimed composition (paragraph 0014). Dissolving the product in a solvent for reactivating the lyophilized probiotics before intake is interpreted as intended use of the product. Since Fujimori teaches the same lyophilized product as claimed and therefore the product has the same structure, it would inherently be capable of being dissolved in a solvent for reactivating lyophilized probiotics before intake. Thus, Fujimori teaching anticipates claims 11 and 12.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimori (JP 2003219862 A).
Fujimori teaching has been set forth above.
Fujimori teaches the composition for improving storage stability of microorganisms selected from several bacterial genera, including Lactobacillus and provides examples of microorganisms including Lactobacillus plantarum (paragraph 0007). Fujimori discloses that the composition can be added before or after the freeze-drying treatment (paragraph 00011). Since Fujimori does not explicitly teach application of ornithine composition to Lactobacillus plantarum in one embodiment, 103 rejection is made.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the composition comprising ornithine taught by Fujimori for reactivation of lyophilized Lactobacillus plantarum. One would have been motivated to do so since Fujimori teaches high increase in viability of Bifidobacterium longum that was freeze-dried in the presence of composition comprising ornithine (paragraph 0016) and describes possibility of application of the composition to improve storage stability of multiple lyophilized microorganisms including Lactobacillus plantarum. Therefore, a skilled artisan would have reasonably expected success in reactivation of Lactobacillus plantarum with composition comprising ornithine following the description of the prior art. Thus, Fujimori teaching renders claims 8 and 9 obvious.
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimori (JP 2003219862 A) in view of Ochi (JP 2017093441 A on record in IDS).
The teaching of Fujimori has been set forth above.
Fujimori does not teach the composition to further comprise L-lysine, L-tyrosine and L-histidine and does not teach the lyophilized probiotics to be at a claimed concentration.
Regarding claim 3, Fujimori teaches testing 20 amino acid separately for the composition to improve viability of freeze-dried microorganisms as described above in Example 1 (paragraph 0013). Lysine and histidine were among the tested amino acids providing improvement in viability. Lysine provided 15.8% of survival rate and histidine – 17.7% while survival with ornithine composition was 31.2% compared to 1.2% in the absence of improving composition (p. 15, Table 1).
Regarding claim 3, Ochi teaches survivability improver for lactic acid bacteria containing amino acids as an active ingredient (paragraph 0002). Ochi discloses that the amino acids were selected from tyrosine, tryptophan, histidine, methionine, cysteine, alanine or their mixtures. The survivability was tested at low pH of 2-0 to 6.5 in yogurt or fermented milk and bacteria belonged to Lactobacillus genus(paragraph 0011). Ochi mentions that preferable amino acids are tyrosine, tryptophan, histidine or their mixtures (paragraph 0019). Ochi provides examples of increase in viability of fermented milk containing several Lactobacillus strains in the presence of compositions with tyrosine, tryptophan or histidine when stored at 4°C (Table 2 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine compositions of lysine, histidine and ornithine used to improve survival of lyophilized bacteria in Fujimori teaching. One would have been motivated to do so since “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” (MPEP 2144.06). A skilled artisan would have reasonably expected success in the combination because Fujimori compared 20 amino acid compositions and ornithine, lysine and histidine compositions provided high survival of lyophilized lactic acid bacteria.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add L-tyrosine, or L-tyrosine with L-tryptophan from Ochi teaching to composition for reactivation of lyophilized probiotics composed of ornithine, lysine and histidine as described above based on Fujimori teaching. One would have been motivated to do so since Ochi teaches that tyrosine, tryptophan and histidine are preferably used to increase survival of lactic acid bacteria used in fermented food preparation. A skilled artisan would have reasonably expected success in the combination because both Ochi and Fujimori develop compositions to increase viability of lactic acid bacteria. Thus, combination of Fujimori and Ochi teachings renders claim 3 obvious.
Regarding claim 7, Ochi teaches the lactic acid bacteria present in the range of 106 to 109 CFU/g (paragraph 0034) that reads on claim 7 limitation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Ochi guidance and use the concentration of lactic acid bacteria to be used with the composition for reactivation of lyophilized probiotics based on Fujimori teaching. One would have been motivated to do so since Ochi teaches that probiotics concentration for application of compositions of amino acids to improve survivability of lactic acid bacteria. A skilled artisan would have reasonably expected success in the combination because both Ochi and Fujimori develop compositions to increase viability of lactic acid bacteria. Thus, combination of Fujimori and Ochi teachings renders claim 7 obvious.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimori (JP 2003219862 A) as applied to claim 1 above, and further in view of Haiping (Haiping et al. J. Food Protection, 2010, 73, 715‐719),
The teaching of Fujimori has been set forth above.
Fujimori does not teach the carbohydrate from the selected group in the reactivating composition.
Regarding claims 5 and 6, Haiping teaches protective effect of sucrose composition during freeze-drying on the viability and membrane properties of Lactobacillus casei Zhang (Abstract). Haiping mentions that Lactobacillus casei Zhang is an important probiotic strain (p. 715, left column, 1st paragraph). Haiping discloses protective effect t of the sucrose: “Sucrose at 2.0, 4.0, and 8.0% significantly protected the cell surface EM of L. casei Zhang from drastic changes, in contrast with the cells not treated with sucrose, and the effect was dose related (Fig. 1).” (p. 717, left column, 2nd paragraph). Haiping describes that survival of bacterial cells was significantly improved in samples containing sucrose at all concentrations (p. 718, left column, 2nd paragraph). Haiping states: “The present work suggested that sucrose might have a protective effect by maintaining surface zeta potential, hydrophobicity, fluidity, and integrity of the bacteria membrane.” (p. 718, right column, 2nd paragraph). 2%, 4% and 8% sucrose correspond to 0.2 g, 0.4 g and 0.8 g, respectively, per 10 ml (or 10 g) that reads on the limitation of claim 6.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add sucrose from Haiping teaching to composition for reactivation of lyophilized probiotics of Fujimori teaching. One would have been motivated to do so since Haiping teaches that sucrose protects lyophilized probiotics by increasing viability and maintaining surface zeta potential, hydrophobicity, fluidity, and integrity of the bacteria membrane. A skilled artisan would have reasonably expected success in the combination because both Haiping and Fujimori develop compositions for reactivation of lyophilized lactic acid bacteria. Thus, combination of Fujimori and Haiping teachings renders claims 5 and 6 obvious.
Response to Arguments
Applicant's arguments filed 05/06/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to 35 U.S.C. 102 and 103 rejections have been considered but are moot because the new ground of rejection does not rely on prior art of Choi applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The previous rejections under 35 U.S.C. 102 and 35 U.S.C. 103 have been withdrawn necessitated by amendment of claims 1 and 3 and new rejections were applied as described above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G 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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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653