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. Claims 1-20 are currently pending and under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on January 29, 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.
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.
3. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,911,419 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a method for treating epilepsy or seizure in a subject in need thereof, said method comprising orally administering to said subject a pharmaceutically active dose of a therapeutic composition comprising uncultured fecal bacteria.
Moreover, the patented claims are drawn to a method for treating epilepsy or seizure in a subject in need thereof, said method comprising orally administering to said subject an induction dose of a combination of (i) a therapeutic composition comprising uncultured fecal bacteria and (ii) a cultured bacterial isolate, according to a first dosing schedule; and subsequently orally administering to said subject a maintenance dose of said combination according to a second dosing schedule, wherein said maintenance dose is lower than said induction dose.
The pending claims are anticipated by or obvious over the patented claims.
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.
4. Claim(s) 1-7, 9-12, 14, 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsiao et al., WO 2018/119048 A1; Published: 6/28/18.
Independent claim 1 is drawn to a method for treating epilepsy or seizure in a subject in need thereof, said method comprising orally administering to said subject a pharmaceutically active dose of a therapeutic composition comprising uncultured fecal bacteria.
Hsiao et al. provides methods and compositions related to treating or preventing (prevention meets claim 6) epilepsy and seizures in a subject by administering to the subject a composition comprising Parabacteroides and Akkermansia bacteria, which is derived from a fecal sample (see page 9 and page 12, lines 1-3; meets claim 1). In other embodiments the method comprise depleting the gut microbiota of the subject and administering a composition comprising bacteria of Parabacteroides and Akkermansia. The subject has epilepsy (e.g. refractory or non-refractory epilepsy; generalized/focal)(see page 12, lines 10-14; meets claims 2-4). Hsiao discloses that the composition reduces the frequency of, or delays the onset of, symptoms of a medical condition in a subject relative to a subject which does not receive the composition. For example, reducing the number of seizures in a population of patients receiving treatment relative to an untreated control (see page 10, lines 30-33 and page 11, lines 1-5; meets claim 5). In one example, a subject may undergo treatment with antibiotics or a composition comprising antibiotics to target and decrease the prevalence of pathogenic organisms, and subsequently be treated with a composition described herein (see page 14, lines 22-25; meets claim 12). In some embodiments the composition and methods can replace the ketogenic diet in the treatment of the seizure (see page 12, lines 31-34; meets claim 16).
Moreover, the composition may be formulated for oral delivery and may be in the form of a capsule (see page 13, lines 4-6; meets claim 9 and 19). The capsule may be encapsulated into an enterically-coated, time-released capsule or tablet (see page 17, line 17; meets claim 11). Hsiao discloses that their process involves the transplantation of fecal bacterial from a healthy individual into a recipient. Said capsule can contain freeze-dried material obtained from a healthy donor (see page 13, lines 19-24; meets claims 10, 18 and 20).
Lastly, Hsiao discloses that actual dosage levels of the active ingredients in the pharmaceutical compositions may be varied so as to obtain an amount of the active ingredient which is effective to achieve the desired therapeutic response for a particular patient, composition, and mode of administration without being toxic to the patient. The selected dosage level will depend upon a variety of factors including the activity of the particular agent employed, the route of administration, the time of administration, the rate of excretion or metabolism of the particular compound being employed, the duration of drugs used in combination with the particular compound used, the age, sex, weight, condition and general health and prior medical history of the patient being treated. A physician having ordinary skill in the art can readily determine and prescribe the effective amount of the composition required. For example, the physician could prescribe and/or administer doses of the compounds employed in the composition at lower than that required in order to achieve the desired therapeutic effect and gradually increase the dosage until the desired effect is achieved (see page 20, lines 1-20; meets claim 14).
As it pertains to claim 7, the Office takes the position that the method of the prior art is identical to that which has been claimed. The patent population is the same and the method steps are identical. Therefore, absent evidence to the contrary, the administration of the composition as claimed would necessarily reduce the frequency by at least 10%, 20%, 30%, 50%, 60%, 70%, 80%, or 90% after 4, 8, or 12 weeks of treatment.
5. Claim(s) 1-2, 4-12 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borody, WO2014/078911 A1; Published: 5/30/14.
Independent claim 1 is drawn to a method for treating epilepsy or seizure in a subject in need thereof, said method comprising orally administering to said subject a pharmaceutically active dose of a therapeutic composition comprising uncultured fecal bacteria.
Borody discloses compositions and methods for treating various disorders and conditions in mammals, including chronic disorders in which there is a presence of an abnormal microbiota or an abnormal distribution of microflora in the gastrointestinal tract. The preparation as a medicament for preventing, decreasing the symptoms of, ameliorating, stabilizing or treating grand mal seizures or petit mal seizures (see page 13; meets claims 1, 2 and 4-6). More specifically, Borody discloses a liquid preparation harvested from a fecal material that was passed by passing through an at least about 0.22 micron filter (reading on uncultured; see page 6, meets claim 1). The method comprising administering to an individual in need thereof via the formulation in single, repeat or multiple administrations, deliveries or infusions (see page 13; meets claim 8).
Furthermore, the preparation is further processed or formulated for either freezing or freeze-drying into a powder (see page 7, meets claim 10 and 20). The formulation is formulated as an enteric release composition and optionally the formulation comprises a gastro-resistant coated (see page 11; meets claim 11). Further, it is formulated as a geltab, semisolid , capsule or as an enteral formulation (see page 12; meets claims 9, 11 and 19). In alternative embodiments, methods of the invention comprise pre-treatment, co-treatment, and/or post-treatment with an antibiotic (see page 20, meets claim 12).
As it pertains to claim 7, the Office takes the position that the method of the prior art is identical to that which has been claimed. The patent population is the same and the method steps are identical. Therefore, absent evidence to the contrary, the administration of the composition as claimed would necessarily reduce the frequency by at least 10%, 20%, 30%, 50%, 60%, 70%, 80%, or 90% after 4, 8, or 12 weeks of treatment.
Conclusion
6. No claim is allowed.
7. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571) 272-0857. 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 January 6, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645