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 .
Response to Amendment
Applicant's amendment and argument filed 11/18/2025, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-2, 5, 8-11 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hii Eiichi et. al. (JP2019048803A) and Maria-Bernadette Madel (from IDS, “Abstracts of the ECTS Congress 2018 P062 Implication of microbiota in the emergence of inflammatory osteoclasts: protective effect of Saccharomyces boulardii CNCM I-745” Calcified Tissue International vol. 102, No. S1, 1 May 2018, pages S31-S32). This is a new rejection based on the amendments filed on 11/18/2025.
Eiichi’s general disclosure is about bone formation promoters (see abstract).
Regarding claims 1-2, 5, Eiichi discloses a composition for promoting bone formation, suppressing bone resorption, improving bone remodeling, suppressing osteoclast activity, enhancing osteoblast activity, comprising a polyamine-containing yeast as an active ingredient (see claims 1-8).
Eiichi teaches “as used herein, “promoting bone formation” refers to promoting bone formation by osteoblasts, and preferably refers to promoting bone formation by enhancing osteoblast activity. In the present specification, "osteoblast activity" preferably refers to cell proliferation ability and cell differentiation ability. More preferably, "promoting bone formation" in the present specification refers to promotion of proliferation and maturation of osteoblasts, or promotion of bone formation thereby” (see last para. page 2). This would indicate osteoblastogenesis as instantly claimed.
Eiichi discloses wherein the yeast is Saccharomyces (see product example 1, page 9, bottom of page 6). Eiichi discloses wherein the composition is for treating osteoporosis (see claim 5).
Regarding claims 1 and 9, Eiichi discloses administering the composition orally and in effective amounts (see 2nd last para. of page 2, last 3 paras of page 9).
Regarding claim 8, Eiichi discloses wherein the yeast are lyophilized (see page 6, para. 7).
Regarding claims 10-11, Eiichi teaches drugs such as active vitamin D3 and bisphosphonates have been used to treat osteoporosis (see description first para.).
Eiichi discloses a method for promoting osteoblastogenesis in an individual comprising administering to the individual an effective amount of a yeast cell derived product, however does not teach the Saccharomyces species as Saccharomyces boulardii.
Madel teaches that Saccharomyces boulardii CNCM-I-745, a yeast probiotic has protective effects on bone destruction and osteoporosis and that the conditioned media inhibits osteoclastogenesis in vitro without affecting cell viability. The results demonstrate that specific i-OCL inhibition is highly promising to combat inflammatory bone destruction. There is a protective effect of Saccharomyces boulardii CNCM I-745 on bone destruction the research provides a novel regulatory mechanisms as new therapeutic targets for inflammatory bone loss (see abstract and fig 1).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to use Saccharomyces boulardii and/or the conditioned media in the composition taught by Eiichi, because this species of Saccharomyces is known to have protective effects on bone destruction and osteoporosis. Additionally, the conditioned media inhibits osteoclastogenesis in vitro without affecting cell viability. The results demonstrate that specific i-OCL inhibition is highly promising to combat inflammatory bone destruction. Thus, selection of the species is prima facie obvious to include in a method of treatment of a bone-related disorder.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive. The applicant argues that Eiichi does not suggest using the species S. boulardii and that it would not have been obvious to select this species based on Madel’s art. Madel teaches that this particular species creates a protective effect on bone destruction. Osteoporosis is a bone condition in which bones become weak because the creation of new bone doesn't keep up with the loss of old bone. Protecting bone destruction can therefore assist with the rate of turnover from the osteoclast-osteoblast paradigm. Osteoclast and osteoblast are the cells which tear down and create bone and work in tandem. Inhibition of bone destruction would therefore allow more protection to the person suffering from bone loss.
The applicant argues that the mechanisms of action taught by Madel are different from the mechanisms of action being claimed. The reason to combine Madel with that of Eiichi’s art does not need to be the same reason as the mechanism of action argued by the applicant. The applicant argues that Madel’s invention pertains to osteoclast inhibition whereas the instant invention is directed to osteoblastogenesis. Eiichi teaches the same osteoblastogenesis as claimed and Madel is used to make obvious a reason to select the specific species of S. boulardii. Persons having ordinary skill in the art would realize that the breakdown and remodeling of bone is through both osteoclasts and osteoblasts and that including the S. boulardii species in a method of treating a bone disorder is obvious because it is specifically taught for being useful for treating osteoporosis.
Conclusion
Currently no claims are allowed.
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.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655