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
The response filed on 9-16-2025 is acknowledged. Claims 1-15 are pending and currently under examination.
Claim Rejections Maintained
35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement (biological deposit) requirement is maintained for reasons of record. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It should be noted that Applicant indicated that a statement of availability was enclosed with their response. However, no such statement has been made of record.
As outlined previously, it is apparent that the Lactobacillus plantarum subsp. plantarum PS128 is required in order to practice the invention. Specifically, it is noted that claim 1 recites deposited material and that claims 2-15 depend from claims reciting deposited material The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)).
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejection of claims 1-15 under 35 U.S.C. 103 as being unpatentable over Tsai et al. (WO 2018/014225 – IDS filed on 4-21-2023) and Chen et al. (Journal of Clinical Pediatrics Vol. 37 Issue 5, pages 365-368 – IDS filed on 4-21-2023) is maintained for reasons of record.
Applicant argues:
1. Tsai et al. fail to disclose using Lactobacillus plantarum subsp. plantarum PS 128 to treat AADC; merely disclose movement disorders; and never mention AADC deficiency.
2. It is known in the art that different diseases may present with identical or similar symptoms, while physiological mechanisms underlying the symptoms may differ due to differences in etiology and pathological mechanisms.
3. Cheng et al. describe clinical symptoms and genetic characteristics of patients having AADC deficiency without mentioning tic disorders and basal ganglia disorders or movement disorders disclosed in Tsai et al. Thus a person of ordinary skill in the art cannot reasonably infer that the same active ingredient can treat different diseases based solely on the similarity of symptoms.
4. Cheng et al. are totally silent on Lactobacillus plantarum, much less teach or suggest that Lactobacillus plantarum subsp. plantarum PS128 is effective for treating AADC.
5. Tsai et al. show improvement of MPTP-induced motor deficits and protection of dopaminergic system in mice's brain by Lactobacillus plantarum subsp. plantarum PS 128, as well as amelioration of DOI-induced back muscle contraction and abnormal dopamine signaling pathway in rat's brain by Lactobacillus plantarum subsp. plantarum PS 128 but fails to teach or suggest that Lactobacillus plantarum subsp. plantarum PS 128 is effective for improving motor activity, improving neuron branching, causing alteration of neurotransmitter levels, or improving AADC symptoms brought about by the claimed invention of the present application.
6. Even assuming arguendo that a person of ordinary skill in the art unreasonably combines Tsai et al. with Cheng et al., such combination would still fail to enable the therapeutic effect of Lactobacillus plantarum subsp. plantarum PS 128 in treating AADC deficiency without requiring undue experimentation and/or inventive effort beyond a person of ordinary skill in the art.
7. MPEP § 2143.01 (III) stipulates that "The mere fact that references can be combined or modified does not render the resultant combination obvious unless the results would have been predictable to one of ordinary skill in the art" and MPEP §2143 stipulates: "the obvious to try line of reasoning is not appropriate when, upon consideration of all of the evidence, the outcome would not have been reasonably predictable and the inventor would not have had a reasonable expectation of success."
8. The Examiner fails to point out how a person of ordinary skill in the art could, based on the disclosures of Tsai et al. and Chen et al., establish a connection between the movement disorders described in Tsai et al. and the symptoms of AADC set forth in Chen et al. or a link between lactic acid bacterium disclosed by Tsai et al. and dopamine receptor agonists, levodopa, or 5-hydroxytryptamine mentioned in Chen et al.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Points 1-3, the art is rife with examples of compositions being utilized to treat symptoms regardless of the underlying cause of said symptoms. For example, aspirin is utilized to treat the symptom “headache” regardless of the cause of the headache. Ibuprofen is utilized to treat “muscle pain” regardless of the cause of said pain. Consequently, the skilled artisan would be motivated to use any and all compositions to treat a given malady/symptom.
With regard to Point 4, Chen et al. was cited to demonstrate the clinical general symptoms of AADC. Applicant is reminded that the rejection is based on the combination of the cited references and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With regard to Points 5 and 7-8, Tsai et al. disclose the use of compositions comprising Lactobacillus plantarum subsp. Plantarum PS128 to treat symptoms that are also present in patients with AADC. Given the overlap in symptoms set forth in both Tsai et al. and Chen et al., the skilled artisan would have a reasonable expectation that Lactobacillus plantarum subsp. Plantarum PS128 would be effective in treating the symptoms associated with AADC.
With regard to Point 6, “undue experimentation” is not a criterion upon which obviousness is assessed. The statutes merely require that one of ordinary skill in the art would have had a reasonable expectation of success. Given the disclosure of Tsai et al. and Chen et al. one would have had a reasonable expectation that Lactobacillus plantarum subsp. Plantarum PS128 would be effective in treating the symptoms associated with AADC.
As outlined previously, Tsai et al. disclose the use of compositions comprising Lactobacillus plantarum subsp. Plantarum PS128 to treat tic disorders and basal ganglia disorders (see abstract) and movement disorders including basal ganglia disorder, an essential tremor, a Lewy body disease, hypokinetic disease, various types of peripheral neuropathy, dystonia, hypokinesia (including akinesia), dyskinesia, and tic disorder (see paragraph [0011]. Tsai et al. further disclose the basal ganglia comprise multiple subcortical nuclei, including striatum, pallidum, substantia nigra, and subthalamic nucleus, which are situated at the base of the forebrain of vertebrates. The basal ganglia nuclei are strongly interconnected with several other brain areas including cortex, thalamus, and brainstem. Many studies have indicated that it participates in various cerebral functions such as control of voluntary motor movement, procedural learning, routine behavior, eye movement, cognition and emotion. Numerous and diverse neurological conditions are associated with basal ganglia dysfunction behavior control, including hyperkinetic disorders such as hemiballismus (uncontrolled movement on one side of the body caused by damage to the subthalamic nucleus), dystonia (involuntary movement and slowing of intentional movement caused by metabolic, vascular, and structural abnormalities), psychostimulant addiction and Huntington's disease (primarily striatum damage); hyperkinetic disorders such as Parkinson's disease ( degeneration of the dopamine-producing cells in the substantia nigra pars compacta); and non-motor disorders such as Tourette syndrome (tics disorders caused by dysfunction of the non-motor loops), obsessive-compulsive disorder (OCD, inability to control either thoughts or actions)[see paragraph [0002]]. Moreover, Tsai et al. disclose that Lactobacillus plantarum subsp. Plantarum PS128 modulates dopamine neurotransmission in basal ganglia; increases prefrontal cortical dopamine; significantly increases dopamine metabolites total level and dopamine turnover ratio in prefrontal cortex. Preferably, the neurotransmitter is selected from the group consisting of dopamine (DA), dihydroxyphenylacetic acid (DC), and homo-vanillic acid (HVA) (see paragraph [0038]). Tsai et al. also discloses that the Lactobacillus plantarum subsp. Plantarum PS128 can be administered orally (see paragraph [0041]) at a concentration of 106 to 1014 (see paragraph [0043]; and can be in compositions comprising carriers (see paragraph
Tsai et al. differs from the rejected claims in that they don’t explicitly disclose the use of Lactobacillus plantarum subsp. Plantarum PS128 to treat AADC.
Chen et al. discloses that the current research shows that the clinical general symptoms of AADC comprise dystonia, dyskinesia (hypokinesia, etc.), behavior problems (irritability, etc.), sleep problems (insomnia, hypersomnia), skin (hyperhidrosis, etc.) and the like. Among them, dystonia, oculomotor crisis, hypokinesia are the most common. At present, dopamine receptor agonists, levodopa, 5-hydroxytryptamine, and the like are used for treating AADC (see page 367).
Consequently, given the disclosure of Chen et al. it would have been obvious for one of ordinary skill in the art to utilize the Lactobacillus plantarum subsp. Plantarum PS128 of Tsai et al. to treat AADC.
One would have had a reasonable expectation of success as Lactobacillus plantarum subsp. Plantarum PS128 has been shown to have efficacy in treating symptoms associated AADC (as disclosed by Chen et al.).
With regard to the specific activities disclosed in claim 2-10, given that the Lactobacillus plantarum subsp. Plantarum PS128 of Tsai et al. is the same as that of the rejected claims, they both would have the same biological and immunological characteristics.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 January 6, 2026