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 .
DETAILED ACTION
Claims 9 and 12 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Claim Rejections - 35 USC § 103
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 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (Genomics 112.1 (2020): 703-711, of record in Office Correspondence mailed on 04/03/2025) in view of Kim (US 10,406,184 B2, published 09/10/2019), and Le (Toxicol Rep 5: 314–317." 2018, of record in Office Correspondence mailed on 08/20/2025).
Regarding claims 9 and 12, Huang teaches Lactobacillus plantarum KC3 isolated from plant-associated niches (e.g. pear and kimchi) (page 708 left column last line).
Huang does not teach administering Lactobacillus plantarum KC3 to treat chronic obstructive pulmonary disease (COPD).
However, Kim teaches administering a pharmaceutical composition comprising Lactobacillus plantarum extracellular vesicles to treat chronic obstructive pulmonary disease (COPD), rhinitis, and asthma (Claim 1). Kim teaches that the Lactobacillus plantarum is isolated from kimchi (column 16 line 55). Applicant discloses that instant Lactobacillus plantarum KC3 is isolated from kimchi (page 9 para.4). While Kim teaches the composition does not contain the cells of Lactobacillus plantarum, Kim teaches EVs are secreted from the Lactobacillus plantarum cells into the culture (column 16 lines 55-59). Thus, administering cells of Lactobacillus plantarum or a culture of Lactobacillus plantarum would inherently also administer the bacteria’s secreted extracellular vesicle. One of ordinary skill in the art would be motivated to administer the whole cell or culture instead of only the extracellular vesicles in order to simplify the process and remove the extra step of filtering out and isolating the extracellular vesicles.
Huang and Kim do not teach administering Lactobacillus plantarum KC3 to ameliorate intestinal inflammation.
However, Le teaches effect of Lactobacillus plantarum on inflammatory bowel disease (Title, Abstract) (i.e., intestinal inflammation) and teaches administration of Lactobacillus plantarum decreases the expression of proinflammatory cytokines TNF-α, IL-1β, in vivo and in vitro using intestinal epithelial cells (Tables 1 and 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of Huang by administering Lactobacillus plantarum KC3 to subjects with chronic obstructive pulmonary disease (COPD) and intestinal inflammation, as suggested by Kim and Le. One of ordinary skill in the art would be motivated to do so in order to treat chronic obstructive pulmonary disease, as suggested by Kim, and to ameliorate the intestinal inflammation, as suggested by Le. A skilled artisan would have a reasonable expectation of success in combining the teachings of these references since Huang teaches the strain is isolated from Kimchi (i.e., safe for consumption), Kim teaches safe administration of Lactobacillus plantarum EVs to treat COPD, and Le teaches safe administration of Lactobacillus plantarum strain to subjects with intestinal inflammation. MPEP 2144.06 II states that it is obvious to substitute equivalents known for the same purpose. Since all three references teach strains of the same species, Lactobacillus plantarum, it is obvious to one of ordinary skill in the art to substitute a Lactobacillus plantarum strain for another Lactobacillus plantarum strain.
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 9 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 10 of copending Application No. 17/915306 in view of Le.
Regarding instant claims 9 and 12, copending claim 1 recites a pharmaceutical composition for preventing or treating a respiratory disease, the pharmaceutical composition comprising, as active ingredients, one or more selected from the group consisting of a Lactobacillus plantarum KC3 strain (Accession No: KCTC13375BP), a culture thereof, a fermentation solution thereof, a lysis solution thereof, an extract thereof, and a concentrate of the culture and a Leonurus japonicus extract. Copending claim 10 recites a method for preventing or treating a respiratory disease, the method comprising administering a composition to a subject in need thereof, the composition comprising, as active ingredients, one or more selected from the group consisting of a Lactobacillus plantarum KC3 strain (Accession No: KCTC13375BP), a culture thereof, a fermentation solution thereof, a lysis solution thereof, an extract thereof, and a concentrate of the culture and a Leonurus japonicus extract. Co-pending claim 5 recites the respiratory disease is chronic pulmonary disease, rhinitis, otitis media, viral respiratory disease, sore throat, tonsilitis, pneumonia, asthma, and chronic obstructive pulmonary disease (COPD). Co-pending claims 1, 5, and 10 do not recite administering the strain, a culture thereof, a concentrate of the culture, or a dried material of the culture to ameliorate intestinal inflammation. However, Le teaches effect of Lactobacillus plantarum on inflammatory bowel disease (Title, Abstract) and teaches administration of Lactobacillus plantarum decreases the expression of proinflammatory cytokines TNF-α, IL-1β, in vivo and in vitro (Tables 1 and 2). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition and method recited in co-pending claims 1, 5, and 10 by administering the composition to a subject with intestinal inflammation, as suggested by Le. One of ordinary skill in the art would be motivated to do so in in order to decrease the expression of proinflammatory cytokines and ameliorate the intestinal inflammation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant argues the examiner did not address Applicant’s prior argument.
In response to the argument, the examiner did address Applicant’s prior argument as shown on page 9 of the office correspondence mailed on 08/20/2025.
Applicant argues that Koning and Le do not teach the specific KC3 strain and that different strains can have different effects. Applicant argues Koning does not teach a therapeutic effect on COPD and that Le demonstrates that the effects of L. plantarum are strain-specific and unpredictable.
In response to the argument, Koning is not relied upon in this rejection. Huang teaches Lactobacillus plantarum KC3. New reference Kim teaches Lactobacillus plantarum derived extracellular vesicles, which are secreted from whole cells and are found in the culture, are administered to treat COPD, asthma, and rhinitis. Le teaches Lactobacillus plantarum strains are used to treat intestinal inflammation. Since Kim and Le teach a correlation between Lactobacillus plantarum and treating COPD and intestinal inflammation, one of ordinary skill in the art would be motivated to use other Lactobacillus plantarum strains for the same purpose. While the reported specific mechanism might be different, Le teaches several strains of Lactobacillus plantarum have an effect on the intestinal inflammation disease.
Applicant argues a person of ordinary skill in the art would not have a reasonable expectation that administering the specific KC3 strain would successfully treat both
COPD and intestinal inflammation.
The cited references teach using Lactobacillus plantarum to treat COPD, asthma, rhinitis, and intestinal inflammation. Lactobacillus plantarum KC3 is not novel as discussed above. Huang and Kim teach that the Lactobacillus plantarum is isolated from kimchi, similar to the instant claim as disclosed by Applicant (specification page 9). Conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability (See MPEP 2143.02(I) and MPEP 2143.02(II)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699