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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/21/2026 has been entered.
Priority
This application is a 371 of PCT/KR2021/002034 filed 02/17/2021. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on KR 10-2020-0019129 filed 02/17/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1, 3, 5, 7 and 9-20 are pending. Claims 1 and 5 are amended. Claim 2 and 6 are cancelled. New claims 9-20 are added.
Claims 12-14 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 of species “amelioration of osteoporosis” was made without traverse in the reply filed on 03/29/2025.
Claims 1, 3, 5, 7, 9-11 and 15-17 (claim set as filed on 02/21/2026) are examined of the merits herein.
Withdrawal of Rejections
The response and amendment filed on 02/21/2026 and Declaration under 37 CFR 1.132 of Ji-Hyun Yun are acknowledged. All of the amendment, arguments and Declaration have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5, 7, 9 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites: “amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin”. It is not clear whether amelioration is caused by increase of calcitonin or decrease of osteocalcin or osteoporosis is caused by increase of calcitonin or decrease of osteocalcin. The scope and boundaries of claim 1 are not certain making claim 1 indefinite.
Claim 5 recites: “prevention or amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin”. It is not clear whether prevention or amelioration is caused by increase of calcitonin or decrease of osteocalcin or osteoporosis is caused by increase of calcitonin or decrease of osteocalcin. The scope and boundaries of claim 5 are not certain making claim 1 indefinite.
Claims 9 and 15 have the same issues.
Claims 3 and 7, dependent on claims 1 and 5, respectively, do not solve the issues mentioned above and are rejected.
Claims 10, 11, 16 and 17 recite: “amelioration of osteoporosis is caused” that clarifies the indefinite issue of claims 1, 5, 9 and 15 and therefore these claims are not rejected.
For examination claims 1, 3, 5, 7, 9 and 15 are interpreted as amelioration of osteoporosis and not osteoporosis is caused by increase of calcitonin or decrease of osteocalcin.
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 (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.
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.
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.
Claims 1, 5, 9, 11, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 8309076 B2) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830).
Regarding claims 1, 5, 9, 11, 15 and 17, Kang teaches Lactobacillus gasseri BNR17 strain isolated from human mother’s milk that has probiotic activity, antimicrobial activity and weight gaining inhibitory effect (Abstract). Kang discloses pharmaceutical composition containing Lactobacillus gasseri BNR17 strain for the prevention and treatment of obesity (column 5, lines 36-39) and administration of the composition in the form of tablet or capsule (column 5, lines 40-41). Kang describes composition being food or food additive (claim 4) and provides examples of preparation of fermented milk or other food products as food compositions (column 16, lines 5-22, 55-67). Kang mentions that the taste of the fermented milk was tested and was satisfactory indicating administration of the food composition (column 16, line 21- 22).
Kang does not teach method for treating climacteric syndrome or method of preventing or ameliorating climacteric syndrome which is amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin.
Sivamaruthi teaches influence of probiotic supplementation on climacteric symptoms in menopausal women (Abstract). Sivamaruthi mentions that Lactobacillus species, including Lactobacillus gasseri, are the dominant bacterial species in healthy women (p. 44, left column, 1st paragraph). Sivamaruthi describes that Lactobacillus protects vaginal area from pathogenic colonization by creating acidic conditions, however the richness of Lactobacillus decreases during or after menopause (p. 44, left column, 4th paragraph). Sivamaruthi provides several examples of treatment with the compositions comprising Lactobacillus species in Table 1. For instance, treatment with the composition containing Lactobacillus sporogenes improved climacteric symptoms (Table 1, #2) and treatment of perimenopausal women with probiotic Lactobacillus combinations suppressed such climacteric vasomotor symptoms as hot flash frequency and intensity (p. 44, right column, 4th paragraph). Sivamaruthi mentions that treatment with Lactobacillus gasseri restores normal vaginal microbiota in postmenopausal breast cancer patients (p. 44, right column, last paragraph). Sivamaruthi describes that supplementation of Lactobacillus reuteri to ovariectomized mice significantly reduced bone resorption and osteoclastogenesis thus suggesting that supplementation of L. reuteri suppresses the post-menopausal bone loss (p. 44, right column, 3rd paragraph). The post-menopausal bone loss is associated with osteoporosis as evidenced by Britton Sivamaruthi is referring to (Abstract). Sivamaruthi concludes that: “The reports clearly suggested that the intervention of optimum level of probiotic supplementation along with some nutraceuticals improved the climacteric symptoms and vaginal health status by altering the microbiota.” (p. 45, left column).
Ochi teaches lactic acid bacteria in particular Lactobacillus gasseri strains OLL203195 (column 3, lines 18-20) and OLL2727 (column 3, lines 28-30) and the composition comprising these strains for treating and/or prevention of osteoporosis (column 3, lines 40-41). Ochi describes that the composition can be pharmaceutical composition (column 3, lines 42-43) and food composition (column 3, lines 44-45). Ochi discloses a method for treating and/or preventing osteoporosis comprising step of administering the composition to a subject (column 4, lines 8-10). Ochi provides working example of suppression of the oxalate levels after administration L. gasseri OLL2727 (Figure 1) and mentions osteoporosis as one of oxalic acid-associated disease (column 8, lines 37-40). Osteoporosis is associated with the climacteric syndrome as evidenced by Britton teaching that menopause is the major risk factor for osteoporosis and that half of women over age of 50 will experience osteoporosis (Abstract, p. 1, 1st paragraph).
Kim teaches lactic acid bacteria and their compositions or health functional food useful in preventing and treating female menopausal diseases (Abstract, paragraphs 0008, 0009). Kim describes menopause symptoms including osteoporosis (paragraph 0021). Kim discloses that lactic acid bacteria strains (Lactobacillus plantarum NK3 and Bifidobacterium longum NK49) or their combination have therapeutic effect on menopausal diseases such as treating osteoporosis (paragraph 0052). Kim provides Example 7 of treating osteoporosis in animal model (paragraph 0122). Kim describes measuring osteocalcin as one of the indicators of osteoporosis and discloses that osteocalcin was increased and calcium was decreased in female mice with removed ovaries and that treatment with lactic acid bacteria resulted in the decrease in osteocalcin and increase in calcium (paragraph 0131). Kim mentions that the results suggested that the level of therapeutic effect of lactic acid bacteria was similar to that of estrogen (paragraph 0132).
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the pharmaceutical composition from Kang teaching to the method of treatment or prevention of climacteric symptoms as described by Sivamaruthi. One would have been motivated to do so since Sivamaruthi teaches that probiotic compositions containing Lactobacillus species improve climacteric symptoms. A skilled artisan would have reasonably expected success in the combination because Kang provided novel isolated Lactobacillus gasseri strain and pharmaceutical and food compositions with that strain and Sivamaruthi provided examples of treatment with probiotic Lactobacillus supplementation including Lactobacillus gasseri treatment on climacteric symptoms in menopausal women.
Second, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on Kang and Sivamaruthi teachings to treatment or prevention of climacteric symptom, i.e. osteoporosis, as described by Ochi for compositions comprising Lactobacillus gasseri strains. One would have been motivated to do so since Ochi teaches that pharmaceutical or food compositions containing Lactobacillus gasseri strains can be used for treatment or prevention of osteoporosis which is associated with menopausal/climacteric symptoms as evidenced by Britton and Kang provides novel isolated Lactobacillus gasseri strain of the same species and pharmaceutical and food compositions with that strain and Sivamaruthi teaches treatment of climacteric symptoms with Lactobacillus compositions. A skilled artisan would have reasonably expected success in the combination because Kang, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains.
Last, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that administration of the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on Kang, Sivamaruthi and Ochi teachings for treatment or prevention of osteoporosis will reduce the amount of osteocalcin as described by Kim. One would have been motivated to do that since Kim teaches that administration of compositions containing of lactic acid bacteria strains to mice with signs of osteoporosis decreases osteocalcin concentration and provides therapeutic effect to the level of estrogen. A skilled artisan would have reasonably expected success in that because Kang, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains and Ochi and Kim describe treatment of osteoporosis with lactic acid bacteria strains.
Thus, Kang, Sivamaruthi, Ochi and Kim teachings as evidenced by Britton render claims 1, 5, 9, 11, 15 and 17 obvious.
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 8309076 B2) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830) as applied to claims 1 and 5 above, and further in view of Wei (CN 1490321 A).
Kang, Sivamaruthi, Ochi and Kim teachings have been set forth above.
Kang, Sivamaruthi, Ochi and Kim do not teach method of treatment or prevention or amelioration of climacteric syndrome which is amelioration of osteoporosis to comprise the Sophora japonica extract.
Regarding claim 3 and 7, Wei teaches Sophora japonica extracts, pharmaceutical preparations and functional food products containing these extracts (paragraph 0002). Wei discloses that Sophora japonica extract has special effects and efficacy in treating, preventing or improving osteoporosis, especially postmenopausal osteoporosis, menopausal syndrome or postmenopausal syndrome in women with symptoms such as hot flashes, anxiety and depression(paragraph 0074). Wei provides working example of efficacy of the treatment with the composition of Sophora japonica extract in preventing and treating osteoporosis in animal model (Example 14, paragraphs 0219-0222). The bone mineral density in the model group was significantly lower than in control group and in the group treated with S. japonica extract the bone mineral density was significantly higher than in the model group and even slightly higher than in estradiol-treated group (paragraph 0222). Besides that, the serum osteocalcin level was increased in model group and that level was decreased with S. japonica treatment and was significantly lower compared to estradiol-treated group (paragraph 0224) and biomechanical properties of the bones of ovariectomized rats in model group were significantly improved (paragraph 0233).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add extract of Sophora japonica fruit described by Wei to the pharmaceutical and food compositions comprising Lactobacillus gasseri BNR17 from Kang teaching for treatment or prevention of climacteric symptoms such as osteoporosis based on Kang, Sivamaruthi, Ochi and Kim teachings. One would have been motivated to do so since Wei demonstrated improvement of osteoporosis as climacteric syndrome after application of the composition containing Sophora japonica extract that included increase in bone mineral density, reduction of osteocalcin and improvement of biomechanical properties of the bones in osteoporosis animal model. A skilled artisan would have reasonably expected success in the combination because the composition of Wei and composition based on Kang, Sivamaruthi, Ochi and Kim teachings can be used for the same purpose for treating or preventing climacteric/menopausal syndrome such as osteoporosis including decrease on osteocalcin level. Thus, teachings of Kang, Sivamaruthi, Ochi, Kim and Wei as evidenced by Britton render claims 3 and 7 obvious.
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 8309076 B2) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830) as applied to claims 1, 5, 9 and 15 above, and further in view of Chen (US 20190321420 A1) as evidenced by Garrett (Garrett et al. Endocrinology, 1995, 136, 5202-5211).
Kang, Sivamaruthi, Ochi and Kim teachings have been set forth above.
Kang, Sivamaruthi, Ochi and Kim do not teach amelioration of osteoporosis caused by increase of calcitonin.
Regarding claims 10 and 16, Chen teaches method for preventing, treating or relieving bone diseases including osteoporosis by using compositions of Lactobacillus that increase blood calcium concentration in a subject (paragraphs 0019, 0020). Chen describes using Lactobacillus plantarum GKM3 and Lactobacillus paracasei GK36 (paragraph 0022). Chen mentions that the pharmaceutical and the edible compositions containing these bacteria are capable of achieving equivalent or similar effect compared to commercial drugs for treating bone disease caused by different conditions including menopause (paragraph 0026). Chen describes results of Lactobacillus administration in animal model of osteoporosis and shows improvement of several parameters, including bone volume density, bone mineral density and significant increase in blood calcium concentration (paragraphs 0072, 0074, 0082). Increase in blood calcium concentration stimulates secretion of calcitonin as evidenced by Garrett (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that administration of the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on Kang, Sivamaruthi, Ochi and Kim teachings for treatment or prevention of osteoporosis will increase the amount of calcitonin. One would have been motivated to do that since Chen teaches that administration of compositions containing of Lactobacillus strains in animal model of osteoporosis results in improvement of parameters related to osteoporosis and significant increase in calcium concentration that stimulated calcitonin secretion as evidenced by Garrett. A skilled artisan would have reasonably expected success in that because Kang, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains and Ochi, Kim and Chen describe treatment, prevention and improvement of osteoporosis with lactic acid bacteria strains administration. Thus, teachings of Kang, Sivamaruthi, Ochi, Kim and Chen as evidenced by Britton and Garrett render claims 10 and 16 obvious.
Response to Arguments
Applicant's arguments filed 02/21/2026 have been fully considered but they are not persuasive.
Applicant (addressing p. 10-12, 14 of the Remarks) and Ji-Hyun Yun (addressing paragraphs 11-14 of the Declaration under 37 CFR 1.132) argue that Kang fails to disclose or suggest the treatment or prophylaxis of climacteric syndrome by administering L. gasseri BNR17. Sivamaruthi fails to disclose administering L. gasseri BNR17 for amelioration or prevention of osteoporosis, mentions osteoporosis only once in relation to hormone therapy and describes supplementation of L. gasseri not specifically directed to menopausal conditions or to postmenopausal breast cancer patients. These arguments are not persuasive because:
In response to applicant's arguments against the references individually, 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). In instant case, although Kang does not teach treatment or prophylaxis of climacteric syndrome by administering L. gasseri BNR17, Kang describes pharmaceutical and food compositions of L. gasseri BNR17 strain and their administration. Sivamaruthi teaches that Lactobacillus strains improve climacteric symptoms and provides multiple examples including reduction of bone resorption and osteoclastogenesis resulted from administration of Lactobacillus reuteri to ovariectomized mice (p. 44, right column, 3rd paragraph). Britton teaches that estrogen deficiency is a major risk factor for osteoporosis and that post-menopausal bone loss is associated with osteoporosis (Abstract) indicating that studies with Lactobacillus reuteri described by Sivamaruthi were performed in a model of osteoporosis reproducing conditions of osteoporosis as menopause syndrome. Ochi teaches that pharmaceutical or food compositions containing strains of instant species, Lactobacillus gasseri, can be used for treatment or prevention of osteoporosis (column 4, lines 8-10). Therefore, teachings of Sivamaruthi and Ochi provide motivation to use pharmaceutical composition and food compositions of a novel Lactobacillus gasseri strain of Kang for treatment or prevention of osteoporosis as climacteric symptom.
Applicant (addressing p. 12-14 of the Remarks) and Ji-Hyun Yun (addressing paragraphs 15-20 of the Declaration under 37 CFR 1.132) argue that Ochi describes variability of strains in terms of high oxalic acid-degrading activity demonstrating that it is strain-specific and does not provide substantive evidence or correlation linking oxalic acid-degrading activity to osteoporosis. Additionally, the Declaration of Ji-Hyun Yun provides experimental data showing genetic differences between the applicant’s BNR17 strain and Ochi’s OLL2727 strain with high activity. These arguments are not persuasive because:
Although Ochi teaches different oxalic acid-degrading activity for different strains, Ochi screened different Lactobacillus species and the selected strains with high activity belonged to two species, i.e. L. gasseri and L. amylovorus (Table 1, column 13) one of which is the same species as in Kang teaching. Since different Lactobacillus species were shown by Sivamaruthi to improve climacteric symptoms, including bone loss associated with menopause related osteoporosis, and Ochi teaches strains of the same Lactobacillus species as in Kang teaching to prevent and/or treat osteoporosis, one would have been motivated to expect that L. gasseri BNR17 of Kang teaching can be used for prevention and/or treatment of menopause related osteoporosis. Examiner acknowledges results presented in Declaration 1.132 by Ji-Hyun Yun, that the strain of L. gasseri with highest activity of Ochi teaching is genetically different from instant L. gasseri BNR17 strain and hence is not the same strain. However, the rejection is based on obviousness and not anticipation. The genetic difference between strains of the same species does not exclude that these strains can have the same properties, produce the same metabolites and similarly provide therapeutic effect on osteoporosis unless shown on the contrary.
The argument regarding prior art of Kim that does not mention or suggest BNR17 strain (p. 14 of the Remarks) is not addressed because prior art of Kim is replaced with prior art of Wei as described in the rejection above.
Please note that since “amelioration of osteoporosis” is the elected species of climacteric syndromes, arguments regarding other climacteric syndromes that are not under examination were not addressed.
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.
First Rejection
Claims 1, 5, 9, 11, 15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6 and 8 of U.S. Patent No. US 8309076 B2 (Kang) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830).
Claims 1 and 9 of instant application are directed to method for treating climacteric syndrome comprising administering a pharmaceutical composition comprising Lactobacillus gasseri BNR17 wherein the treatment is amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin. Claims 5 and 15 of instant application are directed to method for preventing or ameliorating climacteric symptoms comprising administering a food composition comprising Lactobacillus gasseri BNR17 wherein the treatment is prevention or amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin. Claims 11 and 17 are drawn to amelioration of osteoporosis caused by decrease of osteocalcin.
Regarding claims 1, 5, 9, 11, 15 and 17, claim 1 of Kang teaches Lactobacillus gasseri BNR17 strain. Claim 3 of Kang teaches composition containing Lactobacillus gasseri BNR17 strain. Claim 4 teaches food composition and claim 6 teaches pharmaceutical composition comprising Lactobacillus gasseri BNR17 strain. Claim 8 teaches a method of inhibiting weight loss comprising administration of Lactobacillus gasseri BNR17.
Claims of Kang do not teach method for treating climacteric syndrome or method of preventing or ameliorating climacteric symptoms which is amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin.
Sivamaruthi teaches influence of probiotic supplementation on climacteric symptoms in menopausal women (Abstract) as described above. Sivamaruthi provides several examples of treatment with the compositions comprising Lactobacillus species in Table 1. For instance, treatment with the composition containing Lactobacillus sporogenes improved climacteric symptoms (Table 1, #2) and treatment of perimenopausal women with probiotic Lactobacillus combinations suppressed such climacteric vasomotor symptoms as hot flash frequency and intensity (p. 44, right column, 4th paragraph). Sivamaruthi mentions that treatment with Lactobacillus gasseri restores normal vaginal microbiota in postmenopausal breast cancer patients (p. 44, right column, last paragraph). Sivamaruthi describes that supplementation of Lactobacillus reuteri to ovariectomized mice significantly reduced bone resorption and osteoclastogenesis thus suggesting that supplementation of L. reuteri suppresses the postmenopausal bone loss (p. 44, right column, 3rd paragraph). The post-menopausal bone loss is associated with osteoporosis as evidenced by Britton Sivamaruthi is referring to (Abstract). Sivamaruthi concludes that: “The reports clearly suggested that the intervention of optimum level of probiotic supplementation along with some nutraceuticals improved the climacteric symptoms and vaginal health status by altering the microbiota.” (p. 45. left column).
Ochi teaches lactic acid bacteria in particular Lactobacillus gasseri strains OLL203195 (column 3, lines 18-20) and OLL2727 (column 3, lines 28-30) and the composition comprising these strains for treating and/or prevention of osteoporosis (column 3, lines 40-41). Ochi describes that the composition can be pharmaceutical composition (column 3, lines 42-43) and food composition (column 3, lines 44- 45). Ochi discloses a method for treating and/or preventing osteoporosis comprising step of administering the composition to a subject (column 4, lines 8-10). Ochi provides working example of suppression of the oxalate levels after administration L. gasseri OLL2727 (Figure 1) and mentions osteoporosis as one of oxalic acid-associated disease (column 8, lines 37-40). Osteoporosis is associated with the climacteric syndrome as evidenced by Britton teaching that menopause is the major risk factor for osteoporosis and that half of women over age of 50 will experience osteoporosis (Abstract, p. 1, 1st paragraph).
Kim teaches lactic acid bacteria and their compositions or health functional food useful in preventing and treating female menopausal diseases (Abstract, paragraphs 0008, 0009). Kim describes menopause symptoms including osteoporosis (paragraph 0021). Kim discloses that lactic acid bacteria strains (Lactobacillus plantarum NK3 and Bifidobacterium longum NK49) or their combination have therapeutic effect on menopausal diseases such as treating osteoporosis (paragraph 0052). Kim provides Example 7 of treating osteoporosis in animal model (paragraph 0122). Kim describes measuring osteocalcin as one of the indicators of osteoporosis and discloses that osteocalcin was increased and calcium was decreased in female mice with removed ovaries and that treatment with lactic acid bacteria resulted in the decrease in osteocalcin and increase in calcium (paragraph 0131). Kim mentions that the results suggested that the level of therapeutic effect of lactic acid bacteria was similar to that of estrogen (paragraph 0132).
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the pharmaceutical and food compositions from Kang teaching to the method of treatment or prevention of climacteric symptoms as described by Sivamaruthi. One would have been motivated to do so since Sivamaruthi teaches that probiotic compositions containing Lactobacillus species improve climacteric symptoms. A skilled artisan would have reasonably expected success in the combination because claims of Kang describe pharmaceutical and food compositions with Lactobacillus gasseri strain and Sivamaruthi provides examples of treatment with probiotic Lactobacillus supplementation including Lactobacillus gasseri on climacteric symptoms in menopausal women.
Second, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on Kang and Sivamaruthi teachings to treatment or prevention of climacteric symptom, i.e. osteoporosis, as described by Ochi for compositions comprising Lactobacillus gasseri strains. One would have been motivated to do so since Ochi teaches that pharmaceutical or food compositions containing Lactobacillus gasseri strains can be used for treatment or prevention of osteoporosis which is associated with menopausal/climacteric symptoms as evidenced by Britton and Kang provides novel isolated Lactobacillus gasseri strain of the same species and pharmaceutical and food compositions with that strain and Sivamaruthi teaches treatment of climacteric symptoms with Lactobacillus compositions. A skilled artisan would have reasonably expected success in the combination because Kang, Sivamaruthi and Ochi teach treatment or prevention of health-related condition or disease with Lactobacillus gasseri strain.
Last, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that administration of the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on Kang, Sivamaruthi and Ochi teachings for treatment or prevention of osteoporosis will reduce the amount of osteocalcin as described by Kim. One would have been motivated to do that since Kim teaches that administration of compositions containing of lactic acid bacteria strains to mice with signs of osteoporosis decreases osteocalcin concentration and provides therapeutic effect to the level of estrogen. A skilled artisan would have reasonably expected success in that because Kang, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains and Ochi and Kim describe treatment of osteoporosis with lactic acid bacteria strains.
Thus, claims 1, 3, 4, 6 and 8 of Kang, Sivamaruthi, Ochi and Kim teachings as evidenced by Britton teaching render claims 1, 5, 9, 11, 15 and 17 obvious.
Claims 3 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6 and 8 of U.S. Patent No. US 8309076 B2 (Kang) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830) as applied to claims 1 and 5 above, and further in view of Wei (CN 1490321 A) .
Claims 3 and 7 of instant application are directed to further comprising a Sophora japonica fruit extract.
Claims of Kang and Sivamaruthi, Ochi and Kim teachings do not teach method of treatment or prevention or amelioration of climacteric syndrome which is amelioration of osteoporosis to comprise the Sophora japonica extract.
Regarding claim 3 and 7, Wei teaches Sophora japonica extracts, pharmaceutical preparations and functional food products containing these extracts (paragraph 0002). Wei discloses that Sophora japonica extract has special effects and efficacy in treating, preventing or improving osteoporosis, especially postmenopausal osteoporosis, menopausal syndrome or postmenopausal syndrome in women with symptoms such as hot flashes, anxiety and depression(paragraph 0074). Wei provides working example of efficacy of the treatment with the composition of Sophora japonica extract in preventing and treating osteoporosis in animal model (Example 14, paragraphs 0219-0222). The bone mineral density in the model group was significantly lower than in control group and in the group treated with S. japonica extract the bone mineral density was significantly higher than in the model group and even slightly higher than in estradiol-treated group (paragraph 0222). Besides that, the serum osteocalcin level was increased in model group and that level was decreased with S. japonica treatment and was significantly lower compared to estradiol-treated group (paragraph 0224) and biomechanical properties of the bones of ovariectomized rats in model group were significantly improved (paragraph 0233).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add extract of Sophora japonica fruits described by Wei to the pharmaceutical and food compositions comprising Lactobacillus gasseri BNR17 from Kang teaching for treatment or prevention of climacteric symptoms such as osteoporosis based on Kang, Sivamaruthi, Ochi and Kim teachings. One would have been motivated to do so since Wei demonstrated improvement of osteoporosis as climacteric syndrome after application of the composition containing Sophora japonica extract that included increase in bone mineral density, reduction of osteocalcin and improvement of biomechanical properties of the bones in osteoporosis animal model. A skilled artisan would have reasonably expected success in the combination because the composition of Wei and composition based on Kang, Sivamaruthi, Ochi and Kim teachings can be used for the same purpose for treating or preventing climacteric/menopausal syndrome such as osteoporosis including decrease on osteocalcin level. Thus, claims 1, 3, 4, 6 and 8 of Kang, Sivamaruthi, Ochi, Kim and Wei teachings as evidenced by Britton render claims 3 and 7 obvious.
Claims 10 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6 and 8 of U.S. Patent No. US 8309076 B2 (Kang) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830) as applied to claims 1, 5, 9 and 15 above, and further in view of Chen (US 20190321420 A1) as evidenced by Garrett (Garrett et al. Endocrinology, 1995, 136, 5202-5211).
Claims 10 and 16 of instant application are directed to amelioration of osteoporosis caused by increase of calcitonin.
Kang, Sivamaruthi, Ochi and Kim teachings have been set forth above.
Kang, Sivamaruthi, Ochi and Kim do not teach amelioration of osteoporosis caused by increase of calcitonin.
Regarding claims 10 and 16, Chen teaches method for preventing, treating or relieving bone diseases including osteoporosis by using compositions of Lactobacillus that increase blood calcium concentration in a subject (paragraphs 0019, 0020). Chen describes using Lactobacillus plantarum GKM3 and Lactobacillus paracasei GK36 (paragraph 0022). Chen mentions that the pharmaceutical and the edible compositions containing these bacteria are capable of achieving equivalent or similar effect compared to commercial drugs for treating bone disease caused by different conditions including menopause (paragraph 0026). Chen describes results of Lactobacillus administration in animal model of osteoporosis and shows improvement of several parameters, including bone volume density, bone mineral density and significant increase in blood calcium concentration (paragraphs 0072, 0074, 0082). Increase in blood calcium concentration stimulates secretion of calcitonin as evidenced by Garrett (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that administration of the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on Kang, Sivamaruthi, Ochi and Kim teachings for treatment or prevention of osteoporosis will increase the amount of calcitonin. One would have been motivated to do that since Chen teaches that administration of compositions containing of Lactobacillus strains in animal model of osteoporosis results in improvement of parameters related to osteoporosis and significant increase in calcium concentration that stimulated calcitonin secretion as evidenced by Garrett. A skilled artisan would have reasonably expected success in that because Kang, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains and Ochi, Kim and Chen describe treatment, prevention and improvement of osteoporosis with lactic acid bacteria strains administration. Thus, claims 1, 3, 4, 6 and 8 of Kang, Sivamaruthi, Ochi, Kim and Chen teachings as evidenced by Britton and Garrett render claims 10 and 16 obvious.
Therefore, since instant claims 1, 3, 5, 7, 9-11 and 15-17 encompass the subject matter of the reference claims 1, 3, 4, 6 and 8 they are rejected under obviousness double patenting.
Second Rejection
Claims 1, 5, 9, 11, 15 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 7 of copending Application No. 18/840,577 (reference application) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830).
Claims 1 and 9 of instant application are directed to method for treating climacteric syndrome comprising administering a pharmaceutical composition comprising Lactobacillus gasseri BNR17 wherein the treatment is amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin. Claims 5 and 15 of instant application are directed to method for preventing or ameliorating climacteric symptoms comprising administering a food composition comprising Lactobacillus gasseri BNR17 wherein the treatment is prevention or amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin. Claims 11 and 17 are drawn to amelioration of osteoporosis caused by decrease of osteocalcin.
Regarding claims 1, 5, 9, 11, 15 and 17, claim 1 of reference application teaches a method for preventing or treating sarcopenia comprising administering a pharmaceutical composition comprising Lactobacillus gasseri BNR17 strain. Claim 4 of reference application teaches a method for alleviating a decrease in muscle mass and muscle function comprising administering a food composition comprising Lactobacillus gasseri BNR17 strain. Claim 7 of reference application teaches a method for improving muscular strength and muscular endurance comprising administering a composition comprising Lactobacillus gasseri BNR17 strain.
Claims of reference application do not teach method for treating climacteric syndrome or method of preventing or ameliorating climacteric symptoms which is amelioration of osteoporosis caused by increase of calcitonin or decrease of osteocalcin.
Sivamaruthi teaches influence of probiotic supplementation on climacteric symptoms in menopausal women (Abstract) as described above. Sivamaruthi provides several examples of treatment with the compositions comprising Lactobacillus species in Table 1. For instance, treatment with the composition containing Lactobacillus sporogenes improved climacteric symptoms (Table 1, #2) and treatment of perimenopausal women with probiotic Lactobacillus combinations suppressed such climacteric vasomotor symptoms as hot flash frequency and intensity (p. 44, right column, 4th paragraph). Sivamaruthi mentions that treatment with Lactobacillus gasseri restores normal vaginal microbiota in postmenopausal breast cancer patients (p. 44, right column, last paragraph). Sivamaruthi describes that supplementation of Lactobacillus reuteri to ovariectomized mice significantly reduced bone resorption and osteoclastogenesis thus suggesting that supplementation of L. reuteri suppresses the postmenopausal bone loss (p. 44, right column, 3rd paragraph). The post-menopausal bone loss is associated with osteoporosis as evidenced by Britton Sivamaruthi is referring to (Abstract). Sivamaruthi concludes that: “The reports clearly suggested that the intervention of optimum level of probiotic supplementation along with some nutraceuticals improved the climacteric symptoms and vaginal health status by altering the microbiota.” (p. 45. left column).
Ochi teaches lactic acid bacteria in particular Lactobacillus gasseri strains OLL203195 (column 3, lines 18-20) and OLL2727 (column 3, lines 28-30) and the composition comprising these strains for treating and/or prevention of osteoporosis (column 3, lines 40-41). Ochi describes that the composition can be pharmaceutical composition (column 3, lines 42-43) and food composition (column 3, lines 44- 45). Ochi discloses a method for treating and/or preventing osteoporosis comprising step of administering the composition to a subject (column 4, lines 8-10). Ochi provides working example of suppression of the oxalate levels after administration L. gasseri OLL2727 (Figure 1) and mentions osteoporosis as one of oxalic acid-associated disease (column 8, lines 37-40). Osteoporosis is associated with the climacteric syndrome as evidenced by Britton teaching that menopause is the major risk factor for osteoporosis and that half of women over age of 50 will experience osteoporosis (Abstract, p. 1, 1st paragraph).
Kim teaches lactic acid bacteria and their compositions or health functional food useful in preventing and treating female menopausal diseases (Abstract, paragraphs 0008, 0009). Kim describes menopause symptoms including osteoporosis (paragraph 0021). Kim discloses that lactic acid bacteria strains (Lactobacillus plantarum NK3 and Bifidobacterium longum NK49) or their combination have therapeutic effect on menopausal diseases such as treating osteoporosis (paragraph 0052). Kim provides Example 7 of treating osteoporosis in animal model (paragraph 0122). Kim describes measuring osteocalcin as one of the indicators of osteoporosis and discloses that osteocalcin was increased and calcium was decreased in female mice with removed ovaries and that treatment with lactic acid bacteria resulted in the decrease in osteocalcin and increase in calcium (paragraph 0131). Kim mentions that the results suggested that the level of therapeutic effect of lactic acid bacteria was similar to that of estrogen (paragraph 0132).
First, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the pharmaceutical and food compositions from reference claims to the method of treatment or prevention of climacteric symptoms as described by Sivamaruthi. One would have been motivated to do so since Sivamaruthi teaches that probiotic compositions containing Lactobacillus species improve climacteric symptoms. A skilled artisan would have reasonably expected success in the combination because reference claims describe pharmaceutical and food compositions with Lactobacillus gasseri strain and Sivamaruthi provides examples of treatment with probiotic Lactobacillus supplementation including Lactobacillus gasseri on climacteric symptoms in menopausal women.
Second, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on reference claims and Sivamaruthi teachings to treatment or prevention of climacteric symptom, i.e. osteoporosis, as described by Ochi for compositions comprising Lactobacillus gasseri strains. One would have been motivated to do so since Ochi teaches that pharmaceutical or food compositions containing Lactobacillus gasseri strains can be used for treatment or prevention of osteoporosis which is associated with menopausal/climacteric symptoms as evidenced by Britton and reference claims provide novel Lactobacillus gasseri strain of the same species and pharmaceutical and food compositions with that strain and Sivamaruthi teaches treatment of climacteric symptoms with Lactobacillus compositions. A skilled artisan would have reasonably expected success in the combination because reference claims, Sivamaruthi and Ochi teach treatment or prevention of health-related condition or disease with Lactobacillus gasseri strain.
Last, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that administration of the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on reference claims, Sivamaruthi and Ochi teachings for treatment or prevention of osteoporosis will reduce the amount of osteocalcin as described by Kim. One would have been motivated to do that since Kim teaches that administration of compositions containing of lactic acid bacteria strains to mice with signs of osteoporosis decreases osteocalcin concentration and provides therapeutic effect to the level of estrogen. A skilled artisan would have reasonably expected success in that because reference claims, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains and Ochi and Kim describe treatment of osteoporosis with lactic acid bacteria strains.
Thus, reference claims 1, 4 and 7, Sivamaruthi, Ochi and Kim teachings as evidenced by Britton teaching render claims 1, 5, 9, 11, 15 and 17 obvious.
Claims 3 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 7 of copending Application No. 18/840,577 (reference application) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830) as applied to claims 1 and 5 above, and further in view of Wei (CN 1490321 A) .
Claims 3 and 7 of instant application are directed to further comprising a Sophora japonica fruit extract.
Reference claims and Sivamaruthi, Ochi and Kim teachings do not teach method of treatment or prevention or amelioration of climacteric syndrome which is amelioration of osteoporosis to comprise the Sophora japonica extract.
Regarding claim 3 and 7, Wei teaches Sophora japonica extracts, pharmaceutical preparations and functional food products containing these extracts (paragraph 0002). Wei discloses that Sophora japonica extract has special effects and efficacy in treating, preventing or improving osteoporosis, especially postmenopausal osteoporosis, menopausal syndrome or postmenopausal syndrome in women with symptoms such as hot flashes, anxiety and depression(paragraph 0074). Wei provides working example of efficacy of the treatment with the composition of Sophora japonica extract in preventing and treating osteoporosis in animal model (Example 14, paragraphs 0219-0222). The bone mineral density in the model group was significantly lower than in control group and in the group treated with S. japonica extract the bone mineral density was significantly higher than in the model group and even slightly higher than in estradiol-treated group (paragraph 0222). Besides that, the serum osteocalcin level was increased in model group and that level was decreased with S. japonica treatment and was significantly lower compared to estradiol-treated group (paragraph 0224) and biomechanical properties of the bones of ovariectomized rats in model group were significantly improved (paragraph 0233).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add extract of Sophora japonica fruits described by Wei to the pharmaceutical and food compositions comprising Lactobacillus gasseri BNR17 from reference claims for treatment or prevention of climacteric symptoms such as osteoporosis based on reference claims, Sivamaruthi, Ochi and Kim teachings. One would have been motivated to do so since Wei demonstrated improvement of osteoporosis as climacteric syndrome after application of the composition containing Sophora japonica extract that included increase in bone mineral density, reduction of osteocalcin and improvement of biomechanical properties of the bones in osteoporosis animal model. A skilled artisan would have reasonably expected success in the combination because the composition of Wei and composition based on reference claims, Sivamaruthi, Ochi and Kim teachings can be used for the same purpose for treating or preventing climacteric/menopausal syndrome such as osteoporosis including decrease on osteocalcin level. Thus, reference claims 1, 4 and 7, Sivamaruthi, Ochi, Kim and Wei teachings as evidenced by Britton render claims 3 and 7 obvious.
Claims 10 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 7 of copending Application No. 18/840,577 (reference application) in view of Sivamaruthi (Sivamaruthi et al. Int. J. App. Pharmaceutics, 2018, 10, 43-46), Ochi (US 9283252 B2) and Kim (KR 20190050294 A) as evidenced by Britton (Britton et al. J. Cell Physiol. 2014, 229, 1822-1830) as applied to claims 1, 5, 9 and 15 above, and further in view of Chen (US 20190321420 A1) as evidenced by Garrett (Garrett et al. Endocrinology, 1995, 136, 5202-5211).
Claims 10 and 16 of instant application are directed to amelioration of osteoporosis caused by increase of calcitonin.
Reference claims, Sivamaruthi, Ochi and Kim teachings have been set forth above.
Reference claims, Sivamaruthi, Ochi and Kim do not teach amelioration of osteoporosis caused by increase of calcitonin.
Regarding claims 10 and 16, Chen teaches method for preventing, treating or relieving bone diseases including osteoporosis by using compositions of Lactobacillus that increase blood calcium concentration in a subject (paragraphs 0019, 0020). Chen describes using Lactobacillus plantarum GKM3 and Lactobacillus paracasei GK36 (paragraph 0022). Chen mentions that the pharmaceutical and the edible compositions containing these bacteria are capable of achieving equivalent or similar effect compared to commercial drugs for treating bone disease caused by different conditions including menopause (paragraph 0026). Chen describes results of Lactobacillus administration in animal model of osteoporosis and shows improvement of several parameters, including bone volume density, bone mineral density and significant increase in blood calcium concentration (paragraphs 0072, 0074, 0082). Increase in blood calcium concentration stimulates secretion of calcitonin as evidenced by Garrett (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to expect that administration of the pharmaceutical or food composition comprising Lactobacillus gasseri BNR17 strain based on reference claims, Sivamaruthi, Ochi and Kim teachings for treatment or prevention of osteoporosis will increase the amount of calcitonin. One would have been motivated to do that since Chen teaches that administration of compositions containing of Lactobacillus strains in animal model of osteoporosis results in improvement of parameters related to osteoporosis and significant increase in calcium concentration that stimulated calcitonin secretion as evidenced by Garrett. A skilled artisan would have reasonably expected success in that because reference claims, Sivamaruthi and Ochi teach treatment or prevention of health-related conditions and diseases with Lactobacillus gasseri strains and Ochi, Kim and Chen describe treatment, prevention and improvement of osteoporosis with lactic acid bacteria strains administration. Thus, reference claims 1, 4 and 7, Sivamaruthi, Ochi, Kim and Chen teachings as evidenced by Britton and Garrett render claims 10 and 16 obvious.
Therefore, since instant claims 1, 3, 5, 7, 9-11 and 15-17 encompass the subject matter of the reference claims 1, 4 and 7 they are rejected under obviousness double patenting.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/21/2026 have been fully considered but they are not persuasive.
Applicant argues (addressing p. 14-17 of the Remarks) that: “the subject matter of claims 1, 3, 5, and 7 of the present application is not rendered obvious by the claims of Kang when considered in the context of the disclosures of Sivamaruthi, Ochi, Kim, and Ji, but instead is patentably different and distinct.”. These arguments are not persuasive and were addressed above regarding 103 rejection since the same Kang reference is included in both 103 rejection and double patenting rejection.
The double patenting rejection is maintained and modified necessitated by amendment of claims and new double patenting rejection is added.
Conclusion
No claims are allowed.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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