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 1-5 and newly added claims 20-28, in the reply filed on 5/12/2026 is acknowledged.
Claim 6 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17-19 have been canceled by applicants.
Claims 1-5 and 20-28 as filed on 5/12/2026 are under examination in the instant office action.
Information Disclosure Statement
IDS filed on 5/24/2024 has been considered. The cross-out sigh indicates reference with a wrong number.
Claim Rejections - 35 USC § 112
Indefinite
Claims 27 and 28 are 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 27 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.
Claim 28 is rendered indefinite by the reference of “a ratio” of fats to “the composition” as a whole. The final “composition” of claim 1 comprises microbial culture, protective compounds besides fats. It is believed that claim-recited ratio is intended for “the blend” of two fats (“wherein the blend is in a ratio of about …”) . Thus, there is insufficient antecedent basis for the limitation drawn to ratio in the composition the claims.
Deposit
Claims 25 and 26 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 25 and 26 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 § 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, 3, 5, 20-24, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/076975 (Moti et al) in view of US 10,966,934 (Achkar et al).
The cited WO 2008/076975 (Moti et al) teaches a method for the preparation of a composition comprising a microencapsulated microbial culture (entire document including par. 0061), wherein the method comprises the steps of:
a) obtaining a concentrated cell mass of the microbial culture or a concentrated probiotic (par. 0061, line 4);
b) adding a protective compound to the concentrated cell mass of probiotic to obtain a mixture (par. 0061, lines 5-6);
c) drying the mixture of (b) to obtain a dried mixture (par. 0061, line 6);
d) grinding the dried mixture of (c) to obtain a powder (par. 0061, line 7);
e) coating the dried mixture or the powder with a moisture barrier coating (par. 0061, lines 8-9) which is a blend or a mixture of oil-based substances (0025) and/or various fats (par. 0097); and
f) optionally mixing the coated dried mixture or powder of (e) with an excipient or a generic further ingredient to improve physico-chemical characteristics of the probiotic-containing composition (par. 0033).
The suitable moisture barrier coating materials are fats and/or oils; and they include hydrogenated vegetable oil, glycerides, bees wax, carnauba wax, candelilla wax (par. 0060). The coating is/may be done by any suitable coating techniques including melt or melting fats (0067) at temperature above ambient temperature or body temperature.
The suitable protective compounds are polysaccharides (par. 0022) including fructo-oligosaccharides (oligofructose), pectin, maltodextrin (par. 0058).
The microbial cultures of probiotics include Saccharomyces, Lactobacillus and Bifidobacterium (0051).
The compositions are stable and characterized by a long-term shelf life at ambient or even high temperature and humidity (0040).
Thus, the cited WO 2008/076975 (Moti et al) discloses a method for making a storage stable composition with microencapsulated microbial culture of probiotics by using the same protective compounds and the same fats for coating. But the cited document does not clearly teach a blend of coating materials including at least one/first fat being hydrogenated vegetable oil and the other/second fat being candelilla wax.
However, the prior art, for example: US 10,966,934 (Achkar et al) teaches the use of a mixture including at least one/first fat being hydrogenated vegetable oil and the other/second fat being candelilla wax for coating microparticles with active ingredients (col. 3, lines 62-67).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to use of a mixture including at least two different fats including a hydrogenated vegetable oil as a first fat and a candelilla wax as a second for coating microparticles with active ingredients including probiotics with a reasonable expectation of success in making a storage stable composition with microencapsulated microbial culture of probiotics because fats have been used as moisture barriers for preservation storage stability of probiotic-containing preparations as taught by WO 2008/076975 (Moti et al) and because a mixture including at least one/first fat being hydrogenated vegetable oil and the other/second fat being candelilla wax have been suggested and/or used for coating microparticles with active ingredients as evidenced by US 10,966,934 (Achkar et al).
It is considered to be within the skills of an ordinary practitioner to optimize amounts of preservation materials and/or coating agents upon routine experimentation depending on specific conditions including specific probiotics and specific protection agents in order to achieve a desired stability as 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 1-3, 5, 20-24, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/076975 (Moti et al) in view of US 10,966,934 (Achkar et al) as applied to claims 1, 3, 5, 20-24, 27 and 28 above, and further in view of WO 2010/007931 (Dolmer et al) (IDS reference).
The cited WO 2008/076975 (Moti et al) and US 10,966,934 (Achkar et al) as above.
The cited WO 2008/076975 (Moti et al) discloses a method for making a storage stable composition with microencapsulated microbial culture of probiotics by using the protective compounds for drying and the fats as a moisture barrier for coating , wherein the fats include hydrogenated vegetable oil, glycerides, bees wax, carnauba wax, candelilla wax (par. 0060). In particular, the moisture content or water activity in the final preparation is adjusted to be below 0.2 (0055) as intended for storage conditions under high temperature and humidity (0040).
Further, the cited document WO 2010/007931 (Dolmer et al) clearly teaches that viability of probiotic bacteria is easily challenged in moist environments (page 1, lines 21-23), and that the use of hydrophobic compounds for encapsulation of bacteria cultures including Lactobacillus, Bifidobacterium, Lactococcus, Streptococcus (page 11) provides for maintenance of their viability for at least 6 months and more under ambient temperature (page 2, lines 29-32; fig. 1a), wherein the hydrophobic compounds are fats including hydrogenated vegetable (palm) oil, glycerides, bees wax, carnauba wax, candelilla wax, emulsifying wax (page 4, lines 15-21) or the same fats as used in the method of cited WO 2008/076975 (Moti et al). In particular, in the method of the cited document WO 2010/007931 (Dolmer et al) the water activity of final stable microbial preparations is adjusted to about 0.3 or less (page 4, lines 27-29) as intended for maintenance of their viability for at least 6 months and more under ambient temperature.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to adjust water activity of final dried microbial microencapsulated preparations coated by fats to about 0.3 or less depending on intended storage conditions with a reasonable expectation of success in providing compositions with microencapsulated microbial cultures having increased stability and viability during prolong storage at ambient temperatures 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) and because water activity of final stable microbial preparations of about 0.3 or less provides for maintenance of viability of microbial cultures of probiotics for at least 6 months and more under ambient temperature 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 1-3, 5 and 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/076975 (Moti et al), US 10,966,934 (Achkar et al) and WO 2010/007931 (Dolmer et al) as applied to claims 1-3, 5, 20-24, 27 and 28 above, and further in view of US 9,308,271 (Yde).
The cited references WO 2008/076975 (Moti et al), US 10,966,934 (Achkar et al) and WO 2010/007931 (Dolmer et al) as above.
The cited documents WO 2008/076975 (Moti et al) and WO 2010/007931 (Dolmer et al) 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 WO 2008/076975 (Moti 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 1-5 and 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/076975 (Moti et al), US 10,966,934 (Achkar et al), WO 2010/007931 (Dolmer et al) and US 9,308,271 (Yde) as applied to claims 1-3, 5 and 20-28 above, and further in view of US 4,956,295 (Sudoma).
The cited references WO 2008/076975 (Moti et al), US 10,966,934 (Achkar et al), 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.
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.
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.
Vera Afremova
July 29, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
Prosecution Insights