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 response filed on December 4, 2023 is acknowledged. Claims 1-152 have been canceled. Claims 153-172 have been added. Claims 153-172 are currently pending and under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on April 14, 2025 and February 20, 2024 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
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see for example pages 40-41. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4. Claims 153 and 168-172 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-19 of U.S. Patent No. 11,406,675 B2 in view of Sigma Aldrich; https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/solid-formulation-strategies/mannitol-excipient-solid-drug-formulation?srsltid=AfmBOor3klRh-YRr2hxhz400lgjFTfirGsNu5ZZlfmDjO7aHCgkJi-YZ.
The pending claims are drawn to a pharmaceutical composition, comprising: i. a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp., and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient comprises a moisture absorbent material.
Meanwhile, the patented claims are drawn to a pharmaceutical composition, comprising: i. a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., and at least one strain of Lactobacillus sp.; and
ii. a cryoprotectant, wherein the pharmaceutical composition comprises at least about 0.01% of the cryoprotectant by weight, and wherein the cryoprotectant maintains viability of the purified bacterial population upon the purified bacterial population being frozen or lyophilized.
The pending claims are obvious over the patented claims because adding an excipient to a pharmaceutical composition is well known, been used for this propose for decades and is routine to one of skill in the art. This is evidenced by Sigma Aldrich, which provides support around excipients for solid drug formulation noting that for decades lactose, microcrystalline cellulose and others have been used as fillers in solid does formulations. Furthermore, it notes that Mannitol has become increasingly popular as a filler in common tablet manufacturing technologies including direct compression, roller compaction, and various wet granulation processes. It has advantageous physicochemical characteristics such as low hygroscopicity, inertness with respect to APIs, has no known adverse effects in humans, good compatibility, and the ability to produce extremely robust tablets. Because mannitol is of vegetable origin, there is no bovine or transmissible spongiform encephalopathy (BSE, TSE) risk or issues related to substances of genetically modified origins (GMO). Lastly, Mannitol is also well-suited for the formulation of orally disintegrating tablets, and with a very low water content (<0.3%) it is well-suited for formulation of moisture sensitive APIs.
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 person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claim(s) 153-154, 158-166, and 168-172 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gerardin et al., US 2020/0281991 A1; Published: 9/10/20.
Independent claim 153 is drawn to a pharmaceutical composition, comprising: i. a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp., and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient comprises a moisture absorbent material.
Gerardin et al. disclose pharmaceutical compositions comprising one or more, two or more, three or more purified microorganisms selected from Lactobacillus, Faecalibacterium, and Akkermansia, and a combination thereof (see paragraph 0080&0126; meets claim 153i, 170-171). The composition is formulated to be administered orally as an enteric coated capsule or microcapsule, or formulated as part of or administered together with a food, a food additive, a dairy-based product, a soy-based product or a derivative thereof, a jelly, flavored liquid, ice block, ice cream, or a yogurt (see paragraph 0100; meets claim 168-169). In another aspect, a pharmaceutical composition administered herein is freeze-dried, spray-dried, foam-dried, lyophilized, or powder form. Said pharmaceutical composition administered comprises an excipient and a cryoprotectant comprising polyethylene glycol, and lactose, or a combination thereof (see paragraphs 101-102; meets claim 153ii, 154, 161 (spray-drying lactose encompasses anhydrous lactose), 169 & 172). Additionally, the bacterial mixture comprises 10% of mannitol (see paragraph 105; meets claims 158-160). Lastly, Gerardin discloses suitable diluents and excipients include pharmaceutical grades of physiological saline, dextrose, glycerol, mannitol, lactose, starch, magnesium stearate in an amount from about 1%-5%, 5%-10%, 10%-15%, 15-20%, 20%-25%, 25-30%, 30-35%, 40-45%, 50%-55%, 1%-95%, 2%-95%, 5%-95% (see paragraph 0148; meets claims 162-166).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
6. Claim(s) 153-157, 161, and 167-169 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Jones et al., US 2020/0078421 A1; Published: 3/12/20.
Independent claim 153 is drawn to a pharmaceutical composition, comprising: i. a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp., and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient comprises a moisture absorbent material.
Jones discloses therapeutic compositions comprising a probiotic component, comprising: at least one of Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium animalis, Lactobacillus rhamnosus, and Lactobacillus paracasei; and an excipient selected from microcrystalline cellulose, silica, magnesium stearate, or a combination thereof (see paragraph 0047; meeting claim 153-155). In some embodiments, the excipient is selected from lactose, magnesium stearate (in an amount of about 1mg- about 20mg), sodium carbonate, microcrystalline cellulose (in an amount of about 1mg- about 100mg), silica (in an amount of about 1mg- about 20mg), titanium dioxide, and combinations of any thereof (see paragraph 0043-44; meets claims 154-157, 161, 164-167). Lastly, Jones discloses that the composition may be in a capsule (see paragraph 0048; meets claim 168-169).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
7. Claim(s) 153-154 and 168-172 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lynch et al., WO 2017/152137 A2; Published: 9/8/17.
Independent claim 153 is drawn to a pharmaceutical composition, comprising: i. a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp., and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient comprises a moisture absorbent material.
Lynch discloses microbial compositions including a bacterial populations. The microbial composition includes a therapeutically effective amount of Lactobacillus johnsonii, Faecalibacterium prausnitzii, Akkermansia muciniphila, Myxococcus xanthus and/ or Pediococcus pentosaceus. In embodiments, the microbial composition further includes a pharmaceutically acceptable excipient lactose (see paragraph 0139-0141; meets claims 153-154; 170-171). Said composition is to be administered orally and formulated as a tablet, syrup, emulsion etc., (see paragraph 0142-0143&0146; meets claim 168-169). Lastly, Lynch discloses that the bacteria are deliver in a lyophilized form (see paragraph 0151; meets claim 172).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
8. Claim(s) 153 and 168-172 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kashyap et al., WO 2017/053544 A1 Published: 3/30/17.
Independent claim 153 is drawn to a pharmaceutical composition, comprising: i. a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp., and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient comprises a moisture absorbent material.
Kashyap discloses bacterial compositions including at least two bacteria (e.g. , Roseburia feacis, Faecalibacterium prausnitzii, and optionally Akkermansia muciniphila) belonging to the genera Prevotella, Bacteroides, Clostridium, Faecalibacterium, Eubacterium, Ruminococcus, Peptococcus, Peptostreptococcus , Bifidobacterium, Escherichia, Lactobacillus,
Akkermansia (see page 11; lines 1-13; meets claims 153i and 170-171). Any appropriate method can be used to obtain a culture of bacteria and can be formulated into a medicament, nutritional supplement, added to food for consumption, or can be frozen for later use (see page 12, lines 26-28; meets claim 168-169). Additionally, compositions containing at least two (e.g. , Roseburia feacis, Faecalibacterium prausnitzii, and optionally Akkermansia muciniphila) bacteria can be in the form of a pill, tablet, powder, liquid, capsule, or enema. A medicament or nutritional supplement can be prepared with pharmaceutically acceptable excipients such as binding agents (which are moisture absorbent materials), fillers, lubricants, disintegrants, or wetting agents. In some cases, medicaments or nutritional supplements (e.g. , tablets) can be coated. Liquid preparations for administration can take the form of, for example, solutions, syrups, or suspension, or they can be presented as a dry product for constitution with saline or other suitable liquid vehicle before use (see page 13, lines 1-15; meets claim 153ii, 168-170 &172).
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
9. No claim is allowed.
10. 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.
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, Gary B Nickol can be reached at 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 October 29, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645