DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 12/1/2025 have been received and entered into the case. Claim 14 has been canceled. Claims 1-13 and 15 are pending, Claims 4-9 have been withdrawn, and Claims 1-3, 10-13 and 15 have been considered on the merits, insofar as they read on the elected species of improvement in cognition. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claims 1-2 and 10-13 under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al (Nutrients. 2019;11(4):820.) as evidenced by Neul (Dialogues Clin Neurosci. 2012;14(3):253-262.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 3 under 35 U.S.C. 103 as being unpatentable over Liu et al (Nutrients. 2019;11(4):820.) as evidenced by Neul (Dialogues Clin Neurosci. 2012;14(3):253-262.) and in view of Clarkson et al (Intellect Dev Disabil. 2017;55(6):419-431.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 15 under 35 U.S.C. 103 as being unpatentable over Liu et al (Nutrients. 2019;11(4):820.) as evidenced by Neul (Dialogues Clin Neurosci. 2012;14(3):253-262.) and in view of Bendheim et al (https://www.mountsinai.org/care/neurology/services/movement-disorders. 2018;1.) are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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.
Claims 1-2, 10-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (Nutrients. 2019;11(4):820.) in view of Mayo (Rett syndrome – Augusta Health. 2018;1-5.).
The instant claims recite a method for treating Rett syndrome in a subject in need thereof, comprising administering a composition comprising an effective amount of Lactobacillus plantarum subsp. plantarum PS128 and a carrier thereof to the subject.
Liu teaches a method for studying the effects of Lactobacillus plantarum PS128 on boys with autism spectrum disorder (ASD) aged 7-15 (Title, Abstract), comprising administering probiotic capsules comprising an effective amount of Lactobacillus plantarum PS128 and a carrier thereof to the boys, wherein said probiotic capsules are orally administrated, both probiotic capsules and the carrier are pharmaceutically acceptable, said probiotic capsules contains at least 1 x 109 CFU of the Lactobacillus plantarum PS128, probiotic capsules are administered for at least one week (Abstract, p.3 para 3), and Lactobacillus plantarum PS128 may improve behavioral or social communicative traits of children with ASD, and the scores associated with anxiety and rule-breaking behaviors are nominally reduced in the PS128 group after four-week consumption of PS128 (p.10 para 2).
Liu does not teach treating Rett syndrome in a subject in need thereof (claim 1), and the method further comprises administering physical therapy and occupational therapies (claim 15).
However, Liu does teach the method comprising administering a composition comprising an effective amount of Lactobacillus plantarum PS128 and a carrier thereof to a subject, wherein PS128 reduces anxiety and may improve behavioral or social communicative traits. Mayo teaches that Rett syndrome signs and symptoms include fears and anxiety (p.1 Symptoms), and anxiety and problem behavior may hinder social functioning (p.3 para 1). Mayo teaches treatments that can help patients with Rett syndrome include physical therapy and occupational therapy (p.4 para 1).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer Lactobacillus plantarum PS128 to a subject having Rett syndrome, since Mayo discloses that Rett syndrome signs and symptoms include fears and anxiety, and anxiety and problem behavior may hinder social functioning, and Liu discloses that Lactobacillus plantarum PS128 reduces anxiety and may improve behavioral or social communicative traits. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer physical / occupational therapy to a subject having Rett syndrome, since Mayo discloses treatments that can help patients with Rett syndrome include physical therapy and occupational therapy. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to administer Lactobacillus plantarum PS128 and physical / occupational therapy to a subject having Rett syndrome with a reasonable expectation of success.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (Nutrients. 2019;11(4):820.) in view of Mayo (Rett syndrome – Augusta Health. 2018;1-5.) as applied to claims 1-2, 10-13 and 15 above, further in view of Clarkson et al (Intellect Dev Disabil. 2017;55(6):419-431.).
References cited above do not teach the method wherein the improvement in cognition is assessed by Mullen Scales of Early Learning (claim 3).
Clarkson teaches Mullen Scales of Early Learning is a viable measure for accurately assessing developmental domains in children with Rett syndrome (Abstract).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate Mullen Scales of Early Learning, since Clarkson discloses that Mullen Scales of Early Learning accurately assesses developmental domains in children with Rett syndrome, Mayo discloses that Rett syndrome signs and symptoms include fears and anxiety, anxiety and problem behavior may hinder social functioning, and Liu discloses that Lactobacillus plantarum PS128 reduces anxiety and may improve behavioral or social communication. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate Mullen Scales of Early Learning with a reasonable expectation of success.
Response to Arguments
Applicant argues that the disclosure of PS128 on autism spectrum disorder by Liu fails to anticipate the method for treating Rett syndrome claimed in the present application. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Applicant argues that cited references fail to disclose Rett syndrome, much less teach or suggest the effectiveness of PS128 on treating Rett syndrome. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759