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
Applicant’s amendment filed on 21 October 2025 is entered. Claims 18-20, 25, 28-31 are amended. Claims 21-24 are canceled. Claims 18-20 and 25-31 are pending and under examination.
Priority
Receipt is acknowledged of the English language translation of the certified copy of KR10-2020-0123129. Applicant’s claim to the foreign priority filing date of KR10-2020-0123129 filed 23 September 2020 is perfected. Therefore, the effective filing date is now 23 September 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03 November 2025 is being considered by the examiner.
Claim Objections
Claim 31 is objected to because of the following informalities: the semi-colon after the term “KCCM12783P” on line 2 should be removed. Appropriate correction is required.
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.
Claims 18-20 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Cutcliffe et al. (US 20200268811 A1, 27 August 2020) in view of Strandwitz et al. (US 20190070225 A1, published 07 March 2019).
Cutcliffe teaches a method of treating an ocular disorder, including macular degeneration and glaucoma, comprising orally administering a therapeutic composition comprising microorganisms that increase butyrate in the subject (Cutcliffe [0246] and claims 55 and 68). Lactobacillus plantarum is taught to be one organism suitable for use in the method (Cutcliffe [0037] and [0347]).
Cutcliffe does not teach their Lactobacillus plantarum in their composition is strain NK151 having the accession number KCCM12783P.
Strandwitz teaches administering a therapeutic composition comprising a Lactobacillus plantarum strain with a 16s rDNA having at least 97% identity to a SEQ ID NO: 152 (Strandwitz pg. 9 Table 2, claims 1, 5, and 24, and SEQ ID NO: 152).
Strandwitz does not teach the Lactobacillus plantarum strain NK151 having the accession number KCCM12783P.
However, the 16s rDNA sequence of instant SEQ ID NO: 1 of Lactobacillus plantarum strain NK151 having the accession number KCCM12783P as recited in instant claim 19 is 100% identical to Strandwitz’s 16s rDNA sequence SEQ ID NO: 152 Lactobacillus plantarum strain (See sequence search results in IFW for alignment).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add Strandwitz’s Lactobacillus plantarum strain in Cutcliffe’s method of treating ocular diseases macular degeneration and glaucoma comprising administering Lactobacillus plantarum strains.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Cutcliffe taught that the ocular diseases macular degeneration and glaucoma can be treated by administering therapeutic compositions comprising Lactobacillus plantarum strains, and Strandwitz teaches one such Lactobacillus plantarum strain in a composition which can be administered to a subject. Thus, one of ordinary skill in the art would reasonably expect that Strandwitz’s composition comprising a Lactobacillus plantarum strain with a 16s rDNA sequence 100% identical to the instant strain Lactobacillus plantarum strain NK151 having the accession number KCCM12783P would be suitable for use in Cutcliffe’s method of treating ocular diseases.
As mentioned above, since the Lactobacillus plantarum strain NK151 having the accession number KCCM12783P of the instant invention comprises a 16s rDNA sequence that is 100% identical to the 16s rDNA sequence of the Lactobacillus plantarum strain taught by Strandwitz, it would have been prima facie obvious to one of ordinary skill in the art to use the instant strain, or any strain of Lactobacillus plantarum that has a 16s rDNA sequence at least 97% identical to Strandwitz’s SEQ ID NO: 152, in the obvious method of Cutcliffe in view of Strandwitz.
Claims 25-27 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cutcliffe in view of Strandwitz as applied to claims 18-20 and 28 above, and further in view of Nandakumar et al. (WO 2019036510 A1, published 21 February 2019), and Odamaki et al. (US 20210139842 A1, published 13 May 2021, effectively filed 08 December 2017).
Regarding claims 25-27, Cutcliffe teaches their therapeutic composition comprises Lactobacillus plantarum, Bifidobacterium bifidum, and Bifidobacterium longum (Cutcliffe [0037], [0319], [0321], and [0347]).
Cutcliffe and Strandwitz do not teach Bifidobacterium bifidum NK175 having the accession number KCCM12784P or Bifidobacterium longum NK173 having the accession number KCCM13046P.
Nandakumar teaches SEQ ID NO: 80 and multiple Bifidobacterium bifidum strains having a 16s rDNA sequence that is at least 95% identical to SEQ ID NO: 80 (Nandakumar pg. 3 para. 7 and Fig. 16). The Bifidobacterium bifidum NK175 having the accession number KCCM12784P of the present invention has a 16s rDNA sequence SEQ ID NO: 2, which is 99.5% identical to Nandakumar’s SEQ ID NO: 80 (see Sequence Search results in IFW for alignment). Thus, the Bifidobacterium bifidum NK175 having the accession number KCCM12784P of the present invention encompasses Nandakumar’s Bifidobacterium bifidum strains having 16s rDNA sequences at least 95% identical to Nandakumar’s SEQ ID NO: 80. Additionally, Nandakumar teaches administration of compositions comprising their Bifidobacterium bifidum strains (Nandakumar pg. 3 paras. 8-9).
However, Cutcliffe, Strandwitz, and Nandakumar do not teach Bifidobacterium longum NK173 having the accession number KCCM13046P.
Odamaki teaches SEQ ID NO: 1 and compositions comprising Bifidobacterium longum strain NITE BP-02568 that has a 16s rDNA sequence 100% identical to Odamaki’s SEQ ID NO:1 (Odamaki [0065], [0067], [0230], and Table 2). The Bifidobacterium longum NK173 having the accession number KCCM13046P of the present invention has a 16s rDNA sequence SEQ ID NO: 3, which is 100% identical to Odamaki’s SEQ ID NO: 1 (see Sequence Search results in IFW for alignment). Thus, the Bifidobacterium longum NK173 having the accession number KCCM13046P of the present invention encompasses Odamaki’s Bifidobacterium longum strain NITE BP-02568. Additionally, Odamaki teaches administering a composition comprising Bifidobacterium longum strain NITE BP-02568 (Odamaki [0038]-[0039] and [0122]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to combine 1) a Lactobacillus plantarum strain having a 16s rDNA sequence at least 97% identical to Strandwitz’s SEQ ID NO: 152, including the instant strain Lactobacillus plantarum strain NK151 having the accession number KCCM12783P; 2) a Bifidobacterium bifidum strain having a 16s rDNA sequence that is at least 95% identical to Nandakumar’s SEQ ID NO: 80, including the instant strain Bifidobacterium bifidum NK175 having the accession number KCCM12784P; and 3) a Bifidobacterium longum strain having a 16s rDNA sequence 100% identical to Odamaki’s SEQ ID NO: 1, including the instant strain Bifidobacterium longum NK173 having the accession number KCCM13046P, into a composition to be administered in Cutcliffe’s method of treating an ocular disease comprising administering a therapeutic composition comprising Lactobacillus plantarum, Bifidobacterium bifidum, and Bifidobacterium longum. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Cutcliffe’s teaches administering a therapeutic composition comprising Lactobacillus plantarum, Bifidobacterium bifidum, and Bifidobacterium longum to treat ocular diseases. Strandwitz, Nandakumar, and Odamaki teach strains of Lactobacillus plantarum, Bifidobacterium bifidum, and Bifidobacterium longum, respectively, in administered compositions. Thus, one of ordinary skill in the art would reasonably expect that Strandwitz’s composition comprising a Lactobacillus plantarum strain with a 16s rDNA sequence 100% identical to the instant strain Lactobacillus plantarum strain NK151 having the accession number KCCM12783P; Nandakumar’s composition comprising a Bifidobacterium bifidum strain with a 16s rDNA sequence 100% identical to the instant strain Bifidobacterium bifidum strain NK175 having the accession number KCCM12784P; and Odamaki’s composition comprising a Bifidobacterium longum strain with a 16s rDNA sequence 100% identical to the instant strain Bifidobacterium longum strain NK173 having the accession number KCCM13046P would be suitable for use in Cutcliffe’s method of treating ocular diseases.
Regarding claims 29-31, Cutcliffe teaches that the concentrations of Lactobacillus plantarum, Bifidobacterium bifidum, and/or Bifidobacterium longum in their pharmaceutical composition may range from 101 to 1018 CFUs (Cutcliffe [0446]).
Strandwitz teaches their composition may comprise 104-1011 CFU or greater of the bacterial species (Strandwitz [0120]), but does not teach any concentrations of Bifidobacterium bifidum or Bifidobacterium longum.
Nandakumar teaches the designed composition used within their disclosed examples comprised 107 CFU/strain (Nandakumar pgs. 33-34 bridging para.), but does not teach any concentration of Lactobacillus plantarum or Bifidobacterium longum.
Odamaki teaches that administered composition may comprise the strain in concentrations ranging from 106 to 1012 CFUs (Odamaki [0137]), but does not teach any concentration of Lactobacillus plantarum or Bifidobacterium bifidum.
However, none of Cutcliffe, Strandwitz, Nandakumar, or Odamaki teach any ratios of each of their strains to each other based on colony forming units.
MPEP §2144.05(II)(A) states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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)”.
MPEP §2144.05(II)(B) states “[i]n order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017).
In the instant case, one of ordinary skill in the art would have performed routine experimentation to optimize the relative concentrations and ratios of each of the Lactobacillus plantarum, Bifidobacterium bifidum, and Bifidobacterium longum strains taught by Cutcliffe, Strandwitz, Nandakumar, and Odamaki in order to maximize the therapeutic ability of each strain in the obvious combined composition. One of ordinary skill in the art would have had a reasonable expectation of success in optimizing the concentrations because each of the Lactobacillus plantarum, Bifidobacterium bifidum, and Bifidobacterium longum strains were taught to have suitable therapeutic CFU concentrations within their compositions. Thus, one of ordinary skill in the art would have started at those disclosed CFU concentrations for each strain and optimized the relative amounts of each strain to maximize the therapeutic ability of each strain in the obvious combined composition.
Response to Arguments
Applicant’s arguments, see pg. 2 sec. 4 of the Declaration filed 21 October 2025, with respect to the 35 USC §112(a) biological material enablement rejection has been fully considered and are persuasive. The 35 USC §112(a) biological material enablement rejection of claims 18-31 is withdrawn.
Applicant’s arguments with respect to claims 18-20 and 25-31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s arguments that Lactobacillus plantarum NK151 had unexpected superior effects on treating ocular diseases, referring to Examples 2-3 and 6 (Remarks pgs. 10-14 sec. C), it is noted that Example 6 only compares the effectiveness of the 3 claimed strains relative to each other. There is no data comparing the effectiveness of Lactobacillus plantarum NK151 to other Lactobacillus plantarum strains known in the art, or any other known effective treatment for ocular diseases. Regarding Example 2-3, Applicant’s assertion that Lactobacillus plantarum NK151 exhibits superior anti-inflammatory and growth-inhibitory activity relative to the other Lactobacillus plantarum strains (referring to specification pg. 28 Table 3) is not convincing to establish that Lactobacillus plantarum NK151 has unexpectedly superior effects on treating ocular diseases. Firstly, the claims are not limited to anti-inflammation or growth inhibition. Additionally, only one other Lactobacillus plantarum strain (NK152) was evaluated in Example 2-3, and that strain was a product of Applicant’s isolation process shown in Example 1 (specification pgs. 25-26), not a Lactobacillus plantarum strain known in the art to be suitable for treating ocular diseases. Thus, there is no data demonstrating any superior effects of Lactobacillus plantarum NK151 treating ocular diseases.
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657