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
1. Applicant’s amendment filed on December 3, 2025 is acknowledged. Claims 120-135 have been added. Claims 1, 82, 100, 118 and 120-135 are currently pending.
Election/Restrictions
2. Applicant’s election of Group I in the reply filed on December 3, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 82, 100, and 118 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 3, 2025.
Claims 1 and 120-135 are currently under examination.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on December 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Specification
4. The disclosure is objected to because of the following informalities: Table 3 recites Veillonella atypica Strain A as well as Veillonella parvula Strain B, both having the same accession number, PTA-125711.
Appropriate correction is required.
Claim Objections
5. Claim 121 is objected to for relying on Table 1, Table 2, Table 3 and Table J. MPEP 2173.05(s) (Reference to Figures or Tables) discloses that where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. See MPEP § 608.01(m).
6. Claim 120 is objected to because of the following informalities: said claim recites, in part, in section (2) “aerobic bacteriaor”. There should be a space between ‘bacteria’ and ‘or’. Appropriate correction is required.
7. Claim 124 is objected to because of the following informalities: said claim depends upon a rejected based claim. 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.
8. Claim 125 is rejected under 35 U.S.C. 112, first paragraph, as containing 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.
Dependent claim 125 is drawn to the solid dosage form of claim 124, wherein the Veillonella parvula is Veillonella parvula Strain A (ATCC Deposit Number PTA-125691).
Because it is not clear that cell lines possessing the properties of Veillonella parvula Strain A (ATCC Deposit Number PTA-125691) are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require the use of a suitable deposit for patent purposes a deposit in a public repository is required. Without a publicly available deposit of the above Veillonella parvula Strain A (ATCC Deposit Number PTA-125691), one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event.
Applicant’s referral to the deposit of Veillonella parvula Strain A (ATCC Deposit Number PTA-125691) in paragraph 0109 of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR 1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by the International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application. These requirements are necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring: (a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request; (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application; (c) the deposits will be maintained in the public repository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the repository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of biological material not made under the Budapest Treaty must be filed in the application and must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if test is not done by the depository; and 7) A statement that the deposit is capable of reproduction. As well as a statement that removes restrictions to provide access to this strain upon granting of a patent has not made, either in the instant Specification, nor in Applicant's Remarks.
One of the critical conditions of Deposit is defined in 37 CFR 1.808 requires that the deposit of biological material be made under two conditions: (A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and (B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent. Upon making this statement, the rejection under 35 USC 112, first paragraph will be withdrawn. This rejection can be obviated through perfection of the Deposit and amendment of the claims to clearly set forth the Deposited strains.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the Veillonella parvula Strain A (ATCC Deposit Number PTA-125691) described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundack, 773 F.2d.1216, 227 USPQ (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
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.
9. Claim(s) 1, 120-123, and 126-133 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al., US2019/0240263 A1; Published 8/8/19.
Independent claim 1 is drawn to a solid dosage form of a pharmaceutical composition comprising: a pharmaceutical agent having a total pharmaceutical agent mass that is at least 2.5% and no more than 95% of the total mass of the pharmaceutical composition, wherein the pharmaceutical agent comprises bacteria and/or microbial extracellular vesicles (mEVs) derived therefrom; a diluent having a total mass that is at least 1% and no more than 98% of the total mass of the pharmaceutical composition; a lubricant having a total mass that is at least 0.1% and no more than 5% of the total mass of the pharmaceutical composition; and a glidant having a total mass that is at least 0.01% and no more than 2% of the total mass of the pharmaceutical composition.
Goodman et al., teach compositions comprising Prevotella EVs as therapeutic agents (see paragraph 0068; meets claims 120-121). Specifically, Prevotella Strain B 50329 (NRRL accession number B 50329) (see paragraph 0069; meets claim 123). The pharmaceutical compositions comprising Prevotella EVs and/or Prevotella bacteria provided herein comprises a pharmaceutically acceptable carrier (see paragraph 0086; meets claim 1 and 129). Said pharmaceutical compositions comprise both Prevotella EVs and whole Prevotella bacteria (e.g., live bacteria, killed bacteria, attenuated bacteria) (see paragraph 0087; meets claim 128-129). Further, to confirm sterility and isolation of the EV preparations, EVs are serially diluted onto agar medium used for routine culture of the Prevotella bacteria being tested, and incubated using routine conditions. Non-sterile preparations are passed through a 0.22 um filter to exclude intact cells. To further increase purity, isolated EVs may be DNase or proteinase K treated (see paragraph 0211; meets claim 129). In some embodiments, the pharmaceutical composition comprises at least 1 Prevotella bacterium at an amount about 1×107 to 2×1011 (see paragraph 0089; meets claim 130) and is at least 1%-99% of the particles in the composition (see paragraphs 0095-96; meets claim 1, 122 and 126).
Goodman further teaches a solid composition prepared in the forms of powders, granules, tablets, and capsules (see paragraph 0126; meets claim 1, 130, 133) comprising an excipient including a buffering agent, a preservative, a stabilizer, a binder, a compaction agent, a lubricant, a dispersion enhancer, a disintegration agent, a flavoring agent, a sweetener, and a coloring agent (see paragraph 0119; meets claim 1 and 132). In some embodiments the composition comprises a lubricant as an excipient including magnesium stearate, calcium stearate, zinc stearate, hydrogenated vegetable oils, sterotex, polyoxyethylene monostearate, talc, polyethyleneglycol, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate, and light mineral oil (see paragraph 0123; meets claim 1 and 127). In certain aspects, the methods provided herein include the administration to a subject of a pharmaceutical composition described herein either alone or in combination with an additional therapeutic. In some embodiments, the additional therapeutic is an immunosuppressant, a steroid, cancer therapeutic (see paragraph 0128; meets claim 131).
Moreover, the dosage regimen can be any of a variety of methods and amounts, and can be determined by one skilled in the art according to known clinical factors. As is known in the medical arts, dosages for any one patient can depend on many factors, including the subject's species, size, body surface area, age, sex, immunocompetence, and general health, the particular microorganism to be administered, duration and route of administration, the kind and stage of the disease, for example, tumor size, and other compounds such as drugs being administered concurrently (see paragraph 0171). Appropriate minimum dosage levels of microorganisms can be levels sufficient for the microorganism to survive, grow and replicate. The dose of the pharmaceutical compositions described herein may be appropriately set or adjusted in accordance with the dosage form, the route of administration, the degree or stage of a target disease, and the like. For example, the general effective dose of the agents may range between 0.01 mg/kg body weight/day and 1000 mg/kg body weight/day, between 0.1 mg/kg body weight/day and 1000 mg/kg body weight/day, 0.5 mg/kg body weight/day and 500 mg/kg body weight/day, 1 mg/kg body weight/day and 100 mg/kg body weight/day, or between 5 mg/kg body weight/day and 50 mg/kg body weight/day. The effective dose may be 0.01, 0.05, 0.1, 0.5, 1, 2, 3, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 500, or 1000 mg/kg body weight/day or more, but the dose is not limited thereto (see paragraph 0171). In accordance with the above, in therapeutic applications, the dosages of the active agents used in accordance with the invention vary depending on the active agent, the age, weight, and clinical condition of the recipient patient, and the experience and judgment of the clinician or practitioner administering the therapy, among other factors affecting the selected dosage (see paragraph 0174).
It would have been obvious before the effective filing date of the presently claimed invention to employ the ranges of components as claimed and suggested by Goodman et al. with a reasonable expectation of success because specific concentrations listed in the instant claims, MPEP 2144.05 states, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).”
Limitations such as weight ratios and agent mass are being viewed as limitations of optimizing experimental parameters. Accordingly, the subject matter of the rejected claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
10. Claim(s) 134-135 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al., US2019/0240263 A1; Published 8/8/19 as applied to claims 1, 120-123, and 126-133 above, and further in view of Malm et al., Journal of the American Pharmaceutical Association (Scientific ed.), 1951; 40(10):520-525.
Independent claim 1 is drawn to a solid dosage form of a pharmaceutical composition comprising: a pharmaceutical agent having a total pharmaceutical agent mass that is at least 2.5% and no more than 95% of the total mass of the pharmaceutical composition, wherein the pharmaceutical agent comprises bacteria and/or microbial extracellular vesicles (mEVs) derived therefrom; a diluent having a total mass that is at least 1% and no more than 98% of the total mass of the pharmaceutical composition; a lubricant having a total mass that is at least 0.1% and no more than 5% of the total mass of the pharmaceutical composition; and a glidant having a total mass that is at least 0.01% and no more than 2% of the total mass of the pharmaceutical composition.
Goodman et al. teach the limitations as set forth supra.
Goodman et al. do not specifically teach that their solid dosage form further comprises an enteric coating, as recited in claim 134; or that the enteric coating comprises, for example, cellulose acetate phthalate, as recited in claim 135.
Malm teaches that cellulose acetate phthalate is soluble in buffer solutions and has therefore found a use in the enteric coating field. Addition of plasticizers improves the water resistance of the ester. Enteric coatings of such compositions are more effective than when the ester alone is used (abstract). Cellulose acetate phthalate is desirable to coat tablets for enteric delivery and to provide a smooth coat and efficient coverage (see page 522).
It would have been obvious before the effective filing date of the presently claimed invention to employ cellulose acetate phthalate to enterically coat a solid surface with a reasonable expectation of success. This modification may be viewed as a supplementary component that would be obvious to add to a known composition to aid in enteric delivery. The addition of cellulose acetate phthalate, for example, which is known and suggested in the art for use in enteric coatings would be obvious and the skilled artisan would have been motivated to make this modification because cellulose acetate phthalate is desirable to coat tablets for enteric delivery providing a smooth coat and efficient coverage. The skilled artisan would have had a reasonable expectation of success because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
Furthermore, “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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Accordingly, the subject matter of claims 134 and 135 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 February 20, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645