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
Claims 1-7, 10-12, 15, 17-19, 22-23, 25-26 and 28-29 are pending and currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 3-17-2025 has been considered. An initialed copy is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 10-12, 15, 17-19, 22-23, 25-26 and 28-29 are rejected under 35 U.S.C. 103 as being obvious over Kong et al. (Pilot and Feasibility Studies 2020;6:20 – IDS filed on 3-17-2025) and Cheng et al. (Journal of Food and Drug Analysis Vol. 27, pages 632-648).
Kong et al. discloses the use of probiotics and oxytocin nasal spray as neuro-social-behavioral treatments for patients with autism spectrum disorders (see abstract).
With regard to claims 1 and 28, Kong et al. discloses a method of treating a subject diagnosed with or at risk of autism spectrum disorder (ASD) utilizing Lactobacillus reuteri (L. reuteri) and intranasal OXT spray (see abstract). Kong et al. differs from the rejected claim in that they don’t explicitly disclose the use of Lactobacillus plantarum. Cheng et al. disclose the use of Lactobacillus plantarum subsp. plantarum PS128 to treat boys aged 7-15 with ASD (see section 5.1 on page 643 and Table 4 on page 642). It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the Lactobacillus plantarum subsp. plantarum PS128 of Cheng et al. in the methods of Kong et al. as it constitutes a functional equivalent of the probiotic bacteria disclose by Kong et al. One would have had a reasonable expectation of success as both the Lactobacillus plantarum subsp. plantarum PS128 of Cheng et al. and the Lactobacillus reuteri of Kong et al. were shown to have efficacy in treating patients with ASD.
With regard to claims 2-4, Cheng et al. disclose that their treatment outcomes are measured by ABC, SRS, CBCL, CGI-I and SNAP IV (see Table 4).
With regard to claims 5-7, Cheng et al. disclose that the Lactobacillus plantarum subsp. plantarum PS128 is at a concentration of 3 x 1010 CFU/capsule and administered for 28 days (see page 643) and Kong et al. discloses wherein administration comprises multiple doses of the probiotic composition over the course of about I week, about 2 weeks, about 3 weeks, about 4 weeks, about 5 weeks, about 2 months, about 3 months, about 4 months, about 6 months, about 1 year, or as frequently as symptoms dictate (see page 5). Moreover, while Kong et al. do not explicitly disclose that once a day or multiple times a day, it is well established that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
With regard to claim 10, both Kong et al. and Cheng et al. discloses that the probiotic is administered orally (see page 5, left-hand column of Kong et al. for example).
With regard to 11-12, 15, and 17-18, Kong et al. discloses that their treatment methods comprise multiple doses of oxytocin over the course of about 1 week, about 2 weeks, about 3 weeks, about 4 weeks, about 5 weeks, about 2 months, about 3 months, about 4 months, about 6 months, about 1 year, or as frequently as symptoms dictate (see page 5, right-hand column); that the oxytocin is administered once per day (page 5, left-hand column) and that the dosage of oxytocin nasal spray begins with 1 puff of 4 IU daily and after 1 week, the dose will increase to 1 puff per nostril for both nostrils daily (8 IU/rlr1y)).
With regard to claims 19 and 22-23, given that the combination of the cited references results in the use of the same biological components, they would necessarily have the same biological characteristics as those of the rejected claims.
With regard to claim 25, given the combined references disclose the use of both oxytocin and Lactobacillus plantarum subsp. plantarum PS128 it would have been obvious for one of skill in the art to combine them in a single compound.
With regard to claim 26, Cheng et al. disclose the use of probiotic products comprising multiple bacterial strains (in addition to Lactobacillus plantarum subsp. plantarum PS128) in ASD patients (see page 640).
With regard to claim 29, given that the combination of the cited references results in the use of the same biological components, they would necessarily have the same biological characteristics as those of the rejected claims.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 December 13, 2025