DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 2 – 17 in the reply filed on May 19, 2025 is acknowledged. Claims 2 - 19 are pending; claims 18 - 19 are withdrawn; claims 2 - 17 have been considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 29, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 2 – 17 are rejected 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.
Claims 2, 17 and dependents are drawn to a method of improving motor deficit in a subject having a disease however are rendered indefinite for reciting “(PD)-protective bacteria” in lines 5 and 4, respectively; and “PD-enhancing bacteria” in lines 7 and 6, respectively, as the phrases are not adequately defined by the claim language or specification. Although the specification discusses examples of bacteria that may be encompassed by the phrases in paragraphs 0013 – 0014, these paragraphs fail to definition the phrases. As such, the scope of the claim cannot be clearly ascertained since one practicing the methods would not know what bacteria are required by or excluded from the claim.
Claim 5 should end with a period.
In claim 6, “sp.” should be spelled out.
In claim 7, the phrase “KEGG family K00929, K01034 or K 01035” is not adequately defined by the claim language or specification. It is impossible to determine what bacterial species applicant intends to encompass by the instant phrase.
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.
Claims 2 – 7, 10 – 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12 of U.S. Patent No. 11 707 493. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Regarding claims 2 – 3, 5 – 7, 12, 17 the patent claims a method for improving a synucleinopathy or reducing neuroinflammation in a subject, the method comprising administering a composition comprising an inhibitor of a short chain fatty acid (SCFA) comprising acetate, propionate, or butyrate; and increasing a level of one or more Parkinson's disease (PD)-protective bacteria in a gut microbiota of the subject, wherein the one or more PD-protective bacteria is Lachnospiraceae, Rikenellaceae, Peptostreptococcaceae, or Butyricicoccus, wherein increasing the level of the one or more PD-protective bacteria improves a motor deficit in the subject (claims 1, 4 – 5, 10 – 12). Since the bacteria are the same, they are also inherently part of the same KEGG family.
Regarding claim 4, the diseases include Parkinson's disease, dementia with Lewy body disease, or multiple system atrophy (claim 2).
Regarding claims 10 - 11, the method further comprises administering one or more of the same antibiotics to the subject (claims 6 - 7).
Regarding claims 13 – 14, the method further comprises identifying the subject as having a disease when the subject has an abnormal level of aggregation of α-synuclein (αSyn) and measuring a rate and/or level of αSyn aggregation in the brain of the subject, the clearance rate and/or level of insoluble αSyn protein aggregate in the brain of the subject, or a combination thereof. (claim 3).
Regarding claims 15 – 16, the composition further comprises a pharmaceutically acceptable carrier and is formulated for oral administration (claims 8 - 9).
Claims 2 – 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 14 of U.S. Patent No. 12 329 786. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Regarding claims 2 – 3, 5 – 7, 12, the patent claims a method for improving a synucleinopathy or reducing neuroinflammation in a subject, the method comprising administering a composition comprising an inhibitor of a short chain fatty acid (SCFA) comprising acetate, propionate, or butyrate; and increasing a level of one or more Parkinson's disease (PD)-protective bacteria in a gut microbiota of the subject, wherein the one or more PD-protective bacteria is Lachnospiraceae, Rikenellaceae, Peptostreptococcaceae, or Butyricicoccus, wherein increasing the level of the one or more PD-protective bacteria improves a motor deficit in the subject (claims 1 – 2, 8 – 9, 14). Since the bacteria are the same, they are also inherently part of the same KEGG family.
Regarding claim 4, the diseases include Parkinson's disease, dementia with Lewy body disease, or multiple system atrophy (claim 3).
Regarding claims 8 - 9, gut microbiota from a healthy individual is introduced into the gut of the subject using the same techniques (claim 4 - 5).
Regarding claims 10 - 11, the method further comprises administering one or more of the same antibiotics to the subject (claims 6 - 7).
Regarding claims 13 – 14, the method further comprises identifying the subject as having a disease when the subject has an abnormal level of aggregation of α-synuclein (αSyn) and measuring a rate and/or level of αSyn aggregation in the brain of the subject, the clearance rate and/or level of insoluble αSyn protein aggregate in the brain of the subject, or a combination thereof. (claims 10 - 11).
Regarding claims 15 – 16, the composition further comprises a pharmaceutically acceptable carrier and is formulated for oral administration (claims 12 – 13).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
Prosecution Insights