DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 25, 2026 has been entered.
Claim Amendment
3. The amendment filed June 15, 2026 have been entered. Claims 16-17 have been newly added. Claims 1-5, 9-10, 12, and 14-17 are under consideration.
Withdrawal of Claim Rejections
4. The following rejections have been withdrawn in view of Applicants arguments and amendments:
a) The rejection of claims 1-5, 9-10, 12 and 14-15 under 35 U.S.C. 101; and
b) The rejection of claims 1-4, 9-10, 12, and 14-15 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Bortz et al.
Double Patenting
5. 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.
6. Claims 1-5, 9-10, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,440,519.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a synbiotic composition comprising: a therapeutically effective amount of at least one probiotic strain that produces dopamine from L- 3,4-dihydroxyphenylalanine (L-DOPA); and a therapeutically effective amount of Mucuna powder. The patented claims are drawn to a synbiotic composition comprising: from about 104 CFU to about 1012 CFU of at least one bacterial strain comprising an Enterococcus spp and/or a Vagococcus spp, wherein the bacterial strain produces dopamine; and a time release prebiotic component comprising from about 1 mg/kg to about 100 mg/kg of L-DOPA. The prebiotic component of the patented claims, however velvet beans (Mucuna pruriens) are considered a potential prebiotic component due to their high content of non-digestible carbohydrates.
Both sets of claims recite the same probiotic species, the same co-factor, the same food source time release and/or capsule. Thus, the sets of claims are not patentably distinct.
Response to Arguments
7. Applicant's arguments filed June 15, 2026 have been fully considered but they are not persuasive. Applicants argue that the patented claims do not recite the inclusion of Mucuna powder. However, the patented claims recite a prebiotic component comprising L-DOPA. Mucuna powder comprises L-DOPA and is encompassed within the meaning of a precursor comprising L-DOPA. Accordingly, the rejection is maintained because both sets of claims recite the same probiotic species, the precursor components that encompasses the Mucuna powder which comprises L-DOPA, the same food source time release and/or capsule. Thus, the sets of claims are not patentably distinct and the rejection is maintained. It is noted Applicants requested the rejection is held in abeyance is acknowledged; however the rejection is maintained.
Double Patenting
8. Claims 1-5 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7 and 11 of U.S. Patent No. 11,357,803.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a synbiotic composition comprising: a therapeutically effective amount of at least one probiotic strain that produces dopamine from L- 3,4-dihydroxyphenylalanine (L-DOPA); and a therapeutically effective amount of Mucuna powder. While the patented claims are drawn to a method administering an identical composition comprising a therapeutically effective amount of at least one probiotic strain, such as Enterococcus spp or a Vagococcus spp at about 104 CFU to about 1012 CFU and a precursor of L-DOPA at 1 mg/kg to about 10 mg/kg. The patented claims require a precursor of L-DOPA and the instant claims recite Mucuna powder (derived from Mucuna pruriens) is a well-known, rich, natural source of L-DOPA (levodopa), a direct precursor to the neurotransmitter dopamine.
Therefore, both sets of claims recite the same composition comprising the probiotic species and the same precursor to dopamine all in the same amounts. Thus, these sets of claims are not patentably distinct.
Response to Arguments
9. Applicant's arguments filed June 15, 2026 have been fully considered but they are not persuasive. Applicants argue that the patented claims do not recite the inclusion of Mucuna powder. However, the patented claims recite precursor of the neurochemical comprises L-DOPA. Mucuna powder which comprises L-DOPA is encompassed within the meaning of a precursor to dopamine. Accordingly, the rejection is maintained because both sets of claims recite the same probiotic species, the precursor components which encompasses the Mucuna powder, the same food source time release and/or capsule. Thus, the sets of claims are not patentably distinct and the rejection is maintained. It is noted Applicants requested the rejection is held in abeyance is acknowledged; however the rejection is maintained.
Pertinent Art
10. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Villageliu et al., PLoS One. 2018 Nov 28;13(11):e0207038. Enterococcus sp. has the capacity to produce dopamine in a gastrointestinal-like environment when supplied with the dopamine precursor L-3,4 dihydroxyphenylalanine (L-dopa).
Puspita et al., Velvet Beans as Novel Prebiotic Sources and Their Effects on Gut Microbiota and Short-Chain Fatty Acid Level
Galuska et al., (WO 2016172570 published 2016-10-27; priority to 2015-10-30). Galuska et al., a non-dairy substitute can be produced from comparatively high starch legumes [abstract]. The legume include Velvet bean, cowitch (Muciina pruriens) [para 20]. An additional ingredient that may be added to the liquefied legume material is a probiotic. Probiotic bacteria and yeast can provide various benefits such as promoting gastrointestinal (Gl) tract health, supporting immune functions, and increasing overall body defense mechanisms [para 55]. Thus teaching claims 1 and 3. When used, probiotic cultures from a single culture or a combination of two or more cultures can be combined with the liquefied legume material. Typical probiotics that may be used include Lactobacillus species, such as L. plantarum and Bifidobacterim species. In some examples, probiotic organisms may¬ be added to achieve a count in the final product greater than 10 million/g, such as greater than 50 million/g, or greater than 100 million/g. Thus teaching claims 2 and 6-7.
Conclusion
11. No claims allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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