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 Group I, original claims 1-8 and newly added claims 21-29, in the reply filed on 5/12/2026 is acknowledged.
Claim 9 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 5/12/2026.
Claims 10-20 have been canceled by applicants.
Claims 1-8 and 21-29 as filed on 5/12/2026 are under examination in the instant office action,
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-8 and 21-29 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, step f), recites “coating the powder” of the previous step e), which is optional and, thus, the powder of step f) lacks antecedent basis.
Claim 1, last 2 lines, recites that the protective compound has a hydrophobic content above 2%. This limitation is unclear in the lack of definitions in the as-filed specification. A “protective compound” is a single chemical ingredient as recited in the claims; thus, it has to be hydrophobic as a whole. The claim fails to indicate that “the protective compound “ is a mixture of several ingredients or chemical structures. A cryoprotectant and a lyoprotectant are not required to be together by the virtue of language “or”. Besides, the nature of cryoprotectant and/or lyoprotectant is generic as claimed; and it is uncertain whether they are intended as “hydrophobic”. Same rejection is applied to claim 3.
New claims 21-23 are the same as claims 2, 7 and 8. Thus, the duplicate recitations are unclear as intended.
Claim 25 recites the limitation "the fat” in claim 1. There is insufficient antecedent basis for this limitation in the claim 1.
Claim 29 is rendered indefinite by the phrase “a log10 loss of less than 4 cfu/g”. The way it is written it is not clear whether the loss would be, for example, decrease from 4x1010 CFU to 1x1010 CFU or decrease from 1x1010 CFU to 1x106 CFU.
Deposit
Claims 27 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 27 and 28 require one of ordinary skill in the art to have access to a specific microorganisms Ligilactobacillus animalis (DSM 33570), Bifidobacterium animalis subsp. Lactis (DSM 15954), Lactobacillus acidophilus (DSM 13241), Streptococcus thermophilus (DSM 15957) and Lactococcus lactis subsp. Lactis (DSM 21404).
Because the microorganisms are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganisms are not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by deposit of the microorganisms. The specification does not disclose a repeatable process to obtain the microorganisms and it is not clear from the specification or record that the microorganisms are readily available to the public.
The rejection may be overcome by establishing that each microorganism identified is readily available to the public and will continue to be so for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer, or by an acceptable deposit as set forth herein. See 37 CFR 1.801-1.809.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or a statement by an attorney of record over his/her signature and registration number, stating that the deposit has been made under the Budapest Treaty and that all restrictions imposed by the depositor on availability to the public of the deposited material will be irrevocably removed upon issuance of the patent would satisfy the deposit requirement. See 37 CFR 1.808.
Because DSM has acquired the status of an International Depository in accordance to the Budapest Treaty, a declaration stating that all restrictions will be irrevocably removed upon issuance of the patent will overcome this rejection.
Please, also provide copies of deposit receipts for the record as evidence of viability of the claimed strains.
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)(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, 2, 7, 21, 22, 26 and 29 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Savedboworn et al (IDS reference; Food and Biotechnol., 2019, 28(3), pages 795-805).
The cited reference by Savedboworn discloses a method for the preparation of a composition comprising a microencapsulated microbial culture as intended to increase microbial stability during storage, wherein the method comprises steps of:
a) obtaining a concentrated cell mass of the microbial culture by culturing probiotic Lactobacillus (page 796, col. 2, last par.);
b) adding a protective compound mixture comprising rice protein and fructooligosaccharides to the concentrated cell mass of a) to obtain a mixture (par. bridging pages 796-797);
c) stirring or holding the mixture for about 30 min (page 797, col.1, par. 1, lines 12-13);
d) drying or freeze-drying the mixture to obtain a dried mixture (page 797, col., par, 1);
wherein in the cited method the protective mixture of a protective compound mixture comprising 10% rice protein and 5% fructooligosaccharides (page 797, col. 1, lines 3-4), thus, “hydrophobic content” in the mixture is above 2% or 3 % (weight) as provided by hydrophobic protein.
The claim-recited steps e), f) and g) are optional and/or indefinite as claimed.
As applied to claim 3 and 21: in the cited method “hydrophobic content” in the mixture is above 3 % (weight) as provided by the presence of 10% of hydrophobic protein.
As applied to claims 7 and 22: the “protective compound” mixture comprises at least “oligofructose” which is another name of fructooligosaccharide.
As applied to claim 26: in the cited method the microbial culture is Lactobacillus.
As applied to claim 29: in the cited method the microbial culture of Lactobacillus freeze-dried in a protective mixture of rice protein and fructooligosaccharide (RF) survived over 12 weeks while maintaining about the same viable count of CFU/g without loss; for example: see solid line on figure 3B.
Therefore, the cited reference by Savedboworn is considered to anticipate the claimed method.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 7, 21, 22, 24-26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Savedboworn et al (IDS reference: Food and Biotechnol., 2019, 28(3), pages 795-805) in view of IDS reference WO 2010/007931 (Dolmer et al).
The cited reference by Savedboworn is relied upon as explained above for the disclosure of a method for preparing a composition comprising a microencapsulated microbial culture as intended to increase microbial stability during storage, wherein the method comprising the use of a protective compound mixture with hydrophobic rice protein and various carbohydrates including fructooligosaccharides. The microbial culture includes probiotic bacteria Lactobacillus. The cited reference is silent about the use of fats for making and coating microencapsulated microbial cultures as intended for increased microbial stability during storage.
However, WO 2010/007931 (Dolmer et al) clearly teaches that viability of probiotic bacteria is easily challenged in moist environments (page 1, lines 21-23), that stable microbial preparations have water activity of about 0.3 or less (page 4, lines 27-29) and that the use of hydrophobic compounds for encapsulation of bacteria cultures provides for maintenance of their viability for at least 6 months and more (page 2, lines 29-32; fig. 1a). The hydrophobic compounds are fats including hydrogenated vegetable (palm) oil, glycerides, bees wax, carnauba wax, candelilla wax, emulsifying wax (page 4, lines 15-21) in amounts from about 2% and above (table at pages 39-40). The bacteria suitable for preparations belong to various genera of Lactobacillus, Bifidobacterium, Lactococcus, Streptococcus (page 11).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add hydrophobic fats of WO 2010/007931 (Dolmer et al) as additional hydrophobic coating for microencapsulated bacterial preparations in the method of Savedboworn with a reasonable expectation of success in making compositions comprising microencapsulated microbial cultures with increased stability and viability during prolong storage because protection with hydrophobic fat coatings increase viability and/or stability of probiotic bacterial preparations challenged by moist environments as taught by WO 2010/007931 (Dolmer et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1, 2, 7, 21, 22 and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Savedboworn et al (Food and Biotechnol., 2019, 28(3), pages 795-805) in view of WO 2010/007931 (Dolmer et al) as applied to claims 1, 2, 7, 21, 22, 24-26 and 29 above, and further in view of US 9,308,271 (Yde).
The cited reference by Savedboworn and the cited document WO 2010/007931 (Dolmer et al) are relied upon as above.
The cited documents teach that bacteria suitable for making storage stable and viable bacterial preparation belong to various genera of Lactobacillus, Bifidobacterium, Lactococcus, Streptococcus.
The cited references are silent about the use of specific claim-recited strains.
However, at least some of the claim-recited strains have been knonw and used in the method of making storage stable and viable probiotic preparations.
For example: US 9,308,271 (Yde) teaches the use of strains Bifidobacterium animalis subsp. lactis (DSM 15954), Lactobacillus acidophilus (DSM 13241) and Streptococcus thermophilus (DSM 15957) for making storage stable and viable probiotic preparations (col. 9, lines 7-18; col.1, lines 30-40) with protective compounds including maltodextrin, sodium ascorbate (col. 5, lines 36-37) and modified starch (col. 5, lines 53-55).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to practice method of Savedboworn in view of WO 2010/007931 (Dolmer et al) with various probiotic bacteria including all claim-recited species and strains with a reasonable expectation of success in making viable and storage stable bacterial preparations because various bacteria of genera of Lactobacillus, Bifidobacterium, Lactococcus, Streptococcus including claimed DSM strains are suitable for making storage stable and viable bacterial preparation.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1, 2, 7, 8, and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Savedboworn et al (Food and Biotechnol., 2019, 28(3), pages 795-805), WO 2010/007931 (Dolmer et al) and US 9,308,271 (Yde) as applied to claims 1, 2, 7, 21, 22, and 24-29 above, and further in view of US 4,956,295 (Sudoma).
The cited reference by Savedboworn, and the cited documents WO 2010/007931 (Dolmer et al) and US 9,308,271 (Yde) are relied upon as above. They appear to be silent about adding excipient such as calcium carbonate to bacterial preparations intended for storage.
However, calcium carbonate is a knonw, common and widely used pharmaceutical excipient characterized by low water absorbing capacity, thus, providing for controlling or avoiding increase in moisture content of preparations stored/exposed to humid environments. For example: US 4,956,295 (Sudoma) teaches calcium carbonate as carrier or excipient for making preparations of viable bacteria intended for storage (see entire document including abstract) including Lactobacillus (col. 5).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add excipient such as calcium carbonate to bacterial preparations intended for storage with a reasonable expectation of success in providing storage stable bacterial preparations because calcium carbonate as a carrier or excipient have been commonly used for making preparations of viable bacteria intended for storage.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-8 and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Savedboworn et al (Food and Biotechnol., 2019, 28(3), pages 795-805), WO 2010/007931 (Dolmer et al), US 9,308,271 (Yde) and US 4,956,295 (Sudoma) as applied to claims 1, 2, 7, 8 and 21-29 above, and further in view of US 2017/0196918 (Alvarez Siero et al).
The cited reference by Savedboworn and the cited documents WO 2010/007931 (Dolmer et al), US 9,308,271 (Yde) and US 4,956,295 (Sudoma) are relied upon as above.
In particular, the cited reference by Savedboworn teaches a method for the preparation of a composition comprising a microencapsulated microbial culture as intended to increase microbial stability during storage, wherein the method comprises steps of adding a protective compound to a bacterial culture and holding the mixture of the protective compound with the bacterial cultures for about 30 min while mixing before steps of drying or freeze-drying the mixture. The cited reference by Savedboworn does not explicitly acknowledges the value of the “holding” step although the practice of the “holding” before drying is clearly incorporated into the cited method.
However, it is well knonw in the prior art that holding the mixture of protective compounds with bacterial cells selected for preservation before colling and/or drying for about 15-60 min is intended for equilibrations of materials used, thereby, for minimizing detrimental effects on bacterial cells of the subsequent drying and/or freeze-drying steps; for example: see US 2017/0196918 (Alvarez Siero et al) par. 0044 as a whole including last 7 lines.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to practice “holding” step for some specific time as intended to thorough mix and/or to equilibrate materials used in the method for preservation of viable cells with a reasonable expectation of success in avoiding detrimental effects of drying and/or freeze-drying on viable bacterial cells.
It would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to practice holding step at temperature below room temperature, or about 10°C as encompassed by the claims, for the reasonably expected benefits in decreasing bacterial metabolism and minimizing undesired proliferation and/or consumption-modification of original materials used for preservation.
With respect to limitation drawn to adjusting time depending on pH change, it is noted that it is a routine work for the skilled person to optimize holding time (equilibration time) depending on materials and equipment used. The change of pH or decrease of pH is clearly unavoidable due to metabolism of viable bacteria, particularly, of acid producing lactic bacteria Lactobacillus. Thus, the skilled person would be selecting or optimizing holding time as intended for both sufficient equilibration and minimally unavoidable pH decrease.
Thus, the claimed for invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
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Vera Afremova
July 22, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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