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 .
Claims 1-24 have been canceled. Claims 25-37 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted that the priority documents are not in English and therefore the priority date for prior art purposes is 5-31-2022, the fling date of the International Application.
Election/Restrictions
Applicant’s election without traverse of the species allergic asthma in the reply filed on 2-26-2026 is acknowledged.
Claims 27, 28, 30, 36 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2-26-2026.
Claims 25, 26, 29 and 31-35 are under examination.
Information Disclosure Statement
The information disclosure statement filed 11-30-2025 has been considered. An initialed copy is enclosed.
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.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 25, 26, 29 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Spacova et al (Allergy 74:100-110, 2019) in view of Jang et al (Allergy, Asthma, & Immunology Res, 4(3):150-156, 2012) ,KR20160110232 (citations are to the google translation into English) and KR202000200774A, (published2-26-2020 hereinafter ‘774, references are made to the Google English translation).
Spacova et al teach intranasal administration of probiotic Lactobacillus rhamnosus GG prevents birch pollen-induced alleric asthma in a murine model (see abstract). Lactobacillus rhamnosus GG was administered at 5 x 108 CFU/dose. Effects of preventative treatment were analyzed based on serum antibody levels, cell counts, lung histology, lung cytokine levels and airway hyperreactivity.
Jang et al teach oral administration of Lactobacillus rhamnosus attenuates the feature of allergic asthma in a murine model. Jang et al teach airway hyperresponsiveness, total IgE production, eosinophilic inflammation was suppressed after treatment. Th1 and Th2 cytokines were suppressed. Mice received 1 X109 CFU/600uL/mouse/day.
Spacova et al and Jang et al differ by not teaching intranasal or oral administration of Lactobacillus rhamnosus vesicles.
KR20160110232A teaches that extracellular endoplasmic reticulum-derived extracellular matrix as derived from a lactic acid bacterium active ingredient can be used for the treatment of atopic dermatitis, chronic rhinitis, asthma. Cosmetics or functional foods for the prevention, amelioration, or treatment of inflammatory disease such as inflammation, or inflammatory diseases are contemplated (see abstract; page 2, claims and page 3). ‘232 teaches that the average diameter of the vesicles is from 10-300 nm (page 3). The effective amount of the composition is set forth on page 10, the composition may be a function food or an inhaled composition (see page 11). The treatment of inflammatory disease is described at the bottom of page 11. ‘232 exemplifies the preparation of the vesicles from Lactobacillus isolated from kimchi.
KR202000200774A teaches the use of nanovesicles from the bacteria of the genus Lactobacillus for the prevention, improvement and treating of inflammatory diseases and are secreted naturally or artificially. The Lactobacillus-derived vesicles are derived from Lactobacillus rhamnosus (page 4). Figure 8 and Example 10 teach the anti-inflammatory effect of L. rhamnosus derived vesicles on the secretion of inflammatory mediators and that L. rhamnosus was significantly more effective that the L. plantarum. The composition may be a food or pharmaceutical composition. The composition may be a formulation of an oral nebulizer or inhalant (page 6). The composition can be administered orally or parenterally including nasal or airways and the dosage is determined by the condition and weight of the patient, and the drug form and route of administration and time may be selected by those skilled in the art (page 6 and 7).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute the L. rhamnosus vesicles of ‘774 for the intact L. rhamnosus lactic acid bacterium in the method of prevention/treatment/attenuation of allergic asthma Spacova et al or Jang et al because ‘232 teaches the administration of lactic acid bacteria vesicles for treatment of atopic dermatitis, chronic rhinitis, asthma in cosmetics or functional foods for the prevention, amelioration, or treatment of inflammatory diseases and ‘774 teach that the nanovesicles of L. rhamnosus are useful for treating inflammatory disease and the reduction of associated cytokines. There is a reasonable expectation of success in the treating or alleviation of allergic immune diseases as the nanovesicles from L. rhanmnosus have also been demonstrated by ‘774 to provide for reduction in allergic cytokine production.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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