09597Notice 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
2. Applicants’ arguments and amendments filed on 4/09/2026, overcomes the rejections of record. However, the new grounds of rejection to make 112 second paragraph rejection and amendment of specification as set forth below are not necessitated by applicants’ amendment and, therefore, the following action is Non-Final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 21-23 are pending in this application.
Claims 21- 23 are rejected.
Claim Objections
4. Claim 22 objected to because of the following informalities: Claim 22 deon independent product claim 21 and it is a product claim. Therefore, it is suggested to amend claim 22 as below:
Claim 22. (Currently Amended) The formulation as recited in claim 21 wherein
the functional additive is present to the product in proportions of 50 g/ton to 3000 g/ton.
Appropriate correction is required.
Specification
5. (i) It is to be noted that ‘Specification’ needs to be amended. In specification, in PGPUB, at least in paragraphs ([0048], [0063]) the name of the microorganism e.g. Lactobacillusspp. , or Saccharomycescerevisiae etc. which should be separated as Saccharomyces cerevisiae i.e. separated Genus and species) and also e.g. Lactobacillusspp. , should be Lactobacillus spp. having first letter of Genus should be capital (e.g. L and not l as Lactobacillus) and both the genus and species should be in italics (e.g. . Saccharomyces cerevisiae should be Saccharomyces cerevisiae). Applicants should consider the correction for the paragraph having these issues for the amendments of specification in this respect.
(ii) In specification, in PGPUB, at least in paragraph [0151], “UFC should be “CFU” .
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 21-23 ejected 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.
8. Claims 21, 23 recite “ saccharomyces c. var boulardii “ . Ideally it should be separated as Saccharomyces cerevisiae i.e. separated Genus and species) with italics to all microorganism and having first letter in genus should be capital.
9. Claim 23 recites “ with an encapsulating matrix comprising:” and then 23 also recites “ the percentage by weight of the hydrophobic encapsulating matrix”. There is insufficient antecedent basis for this limitation in the claim 23. Claim 23 should be amended to recite “ with ahydrophobic encapsulating matrix comprising:” in order to overcome antecedent basis rejection.
Allowable subject matter
10. Applicant’s arguments (at least in Remarks, made for Roman et al. , NPL Ran et al. on 10th page – 12th page and Table 1, 19th page) and amendments as filed on 4/09/2026 including further examiner’s amendments which is approved by the applicant’s representative, overcome the rejections of record. Examiner did not find any prior art alone or in combination, to address independent amended claims 21, 23.
Primary prior art by Roman et al. discloses
(a) Roman et al. discloses blended active agent for controlled release of the active agent e.g. blending with calcium stearate with active ingredients ( [0064]) . However, this cannot keep probiotic alive.
(b) coating at m.p. of stearic acid at high temperature 212- degree F (Roma et al. [0078]) which is compatible to Lysine etc. but it is not compatible to threrrmo-sensitive probiotic bacteria for survival. Therefore, even if NPL Ran et al. discloses yeast encapsulation, however, NPL Ran et al. is not compatible.
In contrast, present claims 21, 23 claim
(a) coating with the pre-reacted mixtures of fatty acids and saponified fatty acids with divalent cation (mg and/or Ca) to make encapsulating matrix which is coated at room temperature (in PGPUB [0056] e.g. chamber’s temperature is room temp) to avoid high temperature coating by stearic acid only in Roman et al. [0078]) to keep the probiotics alive. The ratio of 0.05 to 19 is exclusively for the pre-reacted mixtures of fatty acids and saponified fatty acids with divalent cation (mg and/or Ca). Therefore, these are not addressed by the primary prior art by Roman or combined teachings of the prior art used in the last office action.
One closest prior art by Durand et al. (USPN 7157258) is the closest prior art. It teaches (i) saturated fatty acid as coating mixture (col 3 lines 35-40), (ii) can coat the microorganisms ( col 3 lines 55-65) with stearic acid and palmitic acid at 80 degree C (col 7 lines 50, Ex 4) (iii) the amount of coating material in relation to the quantity of microorganism is between 10 to 90 wt.% (col 4 lines 25-35).
However, Durand et al. does not specifically address (i) the specifically claimed ‘coating composition and ratio between mixture of fatty acids and saponified fatty acids with divalent cations of magnesium and/or calcium used to make ‘hydrophobic encapsulating matrix” as claimed in claims 21, 23 and (ii) Durand’s product has low water impermeability , it does not provide an improve viability in highly humid media in up to 5 months nor the thermostability of the microorganisms above 65 degree C as mentioned by the applicants in applicants specification (in PGPUB [0020]).
Examiner’s further proposed amendment was “at least 85% survival at the end of the claims 21, 23 is helpful in this respect. The reason is Durand et al. does not specifically teach “ resistance to extrusion, pelletizing, or baking processes at temperatures of 70°C to 120°C [[.]] with greater than 85% survival.
However, examiner left message on 6/16/2026 for the approval of further amendments to overcome 112 second paragraph issues etc. as discussed above in order to accelerate ‘compact prosecution’. However, applicant’s representative did not call back. Therefore, examiner issued another office action. The action is Non-Final because the 112 second paragraph rejection and specification amendments are not due to amendment of the claims 21, 23.
Therefore, if applicants can amend the claims to overcome claim objection, 112 second paragraph rejection (antecedent) and the specification as discussed above, the claims 21-23 are allowable.
In summary, primary prior art by Roman et al. alone or in combination with other prior arts of record do not disclose specifically the claim limitation of “each one of the probiotic species is in the form of coated probiotic with a hydrophobic encapsulating matrix” wherein the “ hydrophobic matrix comprising mixtures of fatty acids and saponified fatty acids with divalent cations of magnesium and /or calcium in a ratio between 0.05 to 19 for claim 21 and 0.1 to 19 for claim 23” so that the encapsulated thermolabile probiotic is resistance to extrusion, pelletizing, or baking processes at temperatures of 70°C to 120°C and maintains greater than 85% survival in the final product. In combination, the further amendments to overcome 112 second paragraph rejection and amendment of specification will be helpful to consider the application to be in condition for allowance.
However, after receiving further arguments, amendments based on the discussion above, it needs further review for further consideration.
Response to arguments
11. Applicant’s arguments (at least in Remarks, made for Roman et al. , NPL Ran et al. on 10th page – 12th page and Table 1, 19th page) and amendments as filed on 4/09/2026 including further examiner’s amendments which is approved by the applicant’s representative, overcome the rejections of record. However, examiner found specification needs to be amended further and also claim 23 has an antecedent basis (112 second paragraph rejection) as mentioned above.
Therefore, examiner did not make any 103 -obviousness rejection in this office action.
12. Response to prior Interview on June 10, 2026 (attached):
A preliminary brief discussion with attorney Mr. Matthew G. McKinney, Attorney, Reg. No. 46, 920 (Tel. No. 407-841-2330) was made on June 15, 2026 (See attached Interview summary). In brief, upon further review and search, examiner found that applicants arguments and only amendment with the phrase " with greater than 85% survival" at the end of claims 21, 23 as was approved, is sufficient to overcome the rejections of record. However, examiner found specification needs to be amended further and also claim 23 has an antecedent basis (112 second paragraph rejection) as mentioned above.
It is also advisable that if we consider 112 (antecedent) second paragraph rejection, then claims 21, 23 are similar but not identical. Even if claim 23 does not claim Lactobacillus spp. as claimed in claim 21, however, as these microorganisms are in Markush group, therefore “alternative” selection of one microorganism makes claims 21 similar to claim 23. Therefore, in order to distinguish independent claim 23 with independent claim 21, examiner suggests to amend claim 23 to make “in a ratio between 0.1 to 19” in order to have its own independent entity.
In order to accelerate and consider 'compact prosecution' , examiner called and left message on 6/15/2026 to set up an interview further. However, as because examiner did not get any reply back, examiner submitted further office action to mail the application on time.
The rejection is made as non-final.
Conclusion
13. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights