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 .
The claim amendment and response filed on August 10, 2026, are received.
Claims 16, 30, 31, 41-44, 50-52, 54 and 56-86 are canceled by Applicant.
Claims 1-15, 17-29, 32-40, 45-49, 53 and 55 are pending in this application and are being examined.
Restriction/Election:
Applicant’s election without traverse of Group I, claims 1-15, 17-29, 32-40, 45-49, 53 and 55, in the reply filed on 08/10/2026 is acknowledged. Also, claims 16, 30-31, 41-44, 50-52, 54 and 56-86 are canceled by Applicant on 08/10/2026.
Election was made without traverse in the reply filed on 08/10/2026.
Objection(s):
Claims 15, 23 and 24 are objected to because of the following informalities:
In claim 15, line 2, delete “-“ after peroxide.
In claim 23, line 2, replace “0.25*109” with --0.25 x 109--, and replace “12*1010” with –12 x 1010--.
In claim 24, line 2, replace “1.62*109” with --1.62 x 109--, and replace “6.8-11.3*1010” with --6.8-11.3 x 1010--.
Appropriate correction is required.
Claim Rejection - 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.
Claim 1-15, 17-29, 32-40, 45-49, 53 and 55 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.
In claim 1, line 2, the phrase “therapeutically relevant amount” is indefinite because the relevant amount is not defined. There is no special definition for the phrase in the specification. As such, the scope of the claim is not clearly set forth.
Suggestion to obviate the rejection: define the therapeutic relevant amount.
In claim 1, last line, the phrase “metabolic disease or disorder or a bone disease” is confusing and therefore indefinite because it is not exactly clear which diseases applicant is trying to encompass by these recitations. It appears that applicant is trying to claim a metabolic bone disease.
Suggestion to obviate the rejection: for example, replace “metabolic disease or disorder or a bone disease” with – a metabolic bone disease--.
Claim 22 recites the limitation "inactivated" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 1 does not recite an inactivated Parabacteroides goldsteinii.
Suggestion to obviate the rejection: delete the phrase.
Claim 33 recites the limitations "inactivated" and “vesicles from” in claim 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 1 neither recites an inactivated Parabacteroides goldsteinii nor recites vesicles from Parabacteroides goldsteinii.
Suggestion to obviate the rejection: delete "inactivated" and “vesicles from”.
Claim 34 recites the limitation "pharmaceutical or probiotic" in claim 1. There is insufficient antecedent basis for this limitation in the claim. Because claim 1 does not recite a pharmaceutical or probiotic composition.
Suggestion to obviate the rejection: delete “pharmaceutical or probiotic”.
Regarding claim 35, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 20, the phrase “the composition comprises extracellular vesicles from Parabacteroides goldsteinii”, fails to further limit the subject matter of the claim 1 upon which it depends.
Suggestion to obviate the rejection: replace “comprises” with –further comprises--.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejection - 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.
A)
Claims 1, 9-13, 21-29, 32-39, 45, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Trajkovski et al. (WO 2020/069282 A1) and Brenner et al. (US 2001/0021705 A1).
Regarding claim 1, Trajkovski et al. teach a method of treating a disease in a mammalian subject, comprising administering to the mammalian subject a therapeutically relevant amount of:(i) a composition comprising a Parabacteroides goldsteinii, wherein the composition is delivered to the gastrointestinal system of the mammalian subject, wherein the disease is metabolic disease or disorder or a bone disease (a method of treating or preventing a bone disease or increasing bone strength in a mammalian subject comprising administering an amount of a composition comprising a Parabacteroides goldsteinii, and the composition is delivered to the gastrointestinal system of the subject, …, administering from about 1x108 to about 1x1013, etc.) (See for example, p. 2 paragraph [0005]).
Regarding claim 9, Trajkovski et al. teach the Parabacteroides goldsteinii is living or is not inactivated (See for example, p. 3 1st paragraph line 2, and p. 12 paragraph [0026]).
Regarding claim 10, Trajkovski et al. teach the Parabacteroides goldsteinii is inactivated (See for example, p. 3 1st paragraph line 2, and p. 12 paragraph [0026]).
Regarding claim 11, Trajkovski et al. teach the Parabacteroides goldsteinii is heat-inactivated (See for example, p. 3 1st paragraph line 2, and p. 12 paragraph [0026]).
Regarding claim 12, Trajkovski et al. teach the Parabacteroides goldsteinii have been inactivated by heating to about 95-105°C for about 10-20 min (See for example, p. 6 paragraph [0012]).
Regarding claim 13, Trajkovski et al. teach the Parabacteroides goldsteinii have been inactivated by heating to about 100°C for about 15 min (See for example, p. 6 paragraph [0012]).
Regarding claim 21, Trajkovski et al. teach the composition comprises extracellular vesicles from Parabacteroides goldsteinii (See for example, p. 12 paragraph [0026]).
Regarding claims 22, Trajkovski et al. teach the composition comprises about 1 x 108-1 x 1013 or about 1x109-1x1010 cfu of the inactivated Parabacteroides goldsteinii (about 1 x 108-1 x 1013 cfu) (See for example, p. 4 1st paragraph).
Regarding claims 23-24, the subject is administered from about 0.25 x109 to about 12 x 1010 cells/kg body weight of the inactivated Parabacteroides goldsteinii (claim 23), and the subject is administered from about 0.97- 1.6 2x 109 or about 6.8-11.3 x 1010 cells/kg body weight of the inactivated Parabacteroides goldsteinii (claim 24). The amount of cells/kg body weight of the inactivated Parabacteroides goldsteinii in the composition being administered the method taught by Trajkovski et al. would have been optimized by a person of ordinary skill in the art based on the subject and the disease being treated.
Regarding claim 25, Trajkovski et al. teach the inactivated Parabacteroides goldsteinii is heat-inactivated Parabacteroides goldsteinii (See for example, p. 3 1st paragraph line 2, and p. 12 paragraph [0026]).
Regarding claim 26, Trajkovski et al. teach the inactivated Parabacteroides goldsteinii is administered to the subject once per day or once every two days (two doses daily, etc.) (See for example. p. 18, paragraph [0044]).
Regarding claim 27, Trajkovski et al. teach the composition further comprises Lactobacillus gasseri, Lactobacillus reuteri, or Akkermansia muciniphila (Lactobacillus reuteri and Akkermansia muciniphila) (see for example, p. 6 paragraph [0011] and p. 14 paragraph [0034]).
Regarding claim 28, Trajkovski et al. teach the composition is further defined as a pharmaceutical composition (See for example, p. paragraph [0033]).
Regarding claim 29, Trajkovski et al. teach the composition is further defined as a probiotic composition (See for example, p. paragraph [0033]).
Regarding claim 32, Trajkovski et al. teach the pharmaceutical or probiotic composition is administered orally, colonically, via enema, via an orogastric tube, or via a nasogastric tube (See for example, p. 4 lines 16-18).
Regarding claim 33, Trajkovski et al. teach the inactivated Parabacteroides goldsteinii or vesicles from Parabacteroides goldsteinii is comprised in a pharmaceutical or probiotic composition that is resistant to degradation in the stomach but releases bacteria in the small intestine and/or large intestine of the subject.
Regarding claim 34, Trajkovski et al. teach the pharmaceutical or probiotic composition comprises an enteric coating, chitosan-alginate beads, or a hydrogel (a hydrogel, etc.) (See for example, p. 16 paragraph [0039]).
Regarding claim 35, Trajkovski et al. teach the enteric coating is a fatty acid, a wax, a shellac, a plastic such as a phthalate, CAP, CAT, PVAP, HPMCP, or a plant fiber (entering coating is a fatty acid, a wax, a shellac, a plastic, a phthalate, CAP, CAT, PVAP, HPMCP, or a plant fiber) (See for example, p. 16 paragraph [0039]).
Regarding claim 36, Trajkovski et al. teach the pharmaceutical or probiotic composition does not comprise an enteric coating (carriers comprise entering coating) (See for example, p. 16 paragraph [0040])
Regarding claim 37, Trajkovski et al. teach the pharmaceutical or probiotic composition is a tablet or capsule (capsules and tablets) (See for example, p. 16 paragraph [0040]).
Regarding claim 38, Trajkovski et al. teach the subject is a human (treating a human) (See for example, p. 16 paragraph [0041].
Regarding claim 39, Trajkovski et al. teach the human is a postmenopausal woman (osteoporosis in women with postmenopausal oestrogen deficiency) (See for example, p. 1 paragraph [0003]).
Regarding claim 45, Trajkovski et al. teach the bone disease is osteoporosis, osteomalacia, osteolysis, osteochondrodysplasias, periodontitis, rheumatoid arthritis, metabolic bone disease, a parathyroid disorder, steroid-induced osteoporosis, chemotherapy-induced bone loss, pre-menopausal bone loss, fragility and recurrent fractures, renal osteodystrophy, or Paget's disease (osteoporosis, .., Paget's disease) (See for example, p. 2 paragraph [0005], and p. 2 paragraph [0006]).
Regarding claim 46, Trajkovski et al. teach the bone disease is osteoporosis (osteoporosis) (See for example, p. 2 paragraph [0005]).
Regarding claim 47, Trajkovski et al. teach estrogen deficiency is the main factor associated with osteoporosis (see for example, p. paragraph [0061]. As such, administering an estrogen therapy to the subject in the method taught by Trajkovski et al. would have been obvious.
Regarding claim 48, Trajkovski et al. teach the microbiota in the composition has been purified or cultured.
Regarding claim 55, Trajkovski et al. teach Parabacteroides goldsteinii are cultured or expanded in a medium comprising spermidine or spermine prior to inactivation.
Trajkovski et al. do not teach a bisphosphonate (claim 1), the bisphosphonate is alendronate, risedronate, ibandronate, zoledronic acid, denosumab, raloxifene, or bazedoxifene (claim 2), and the bisphosphonate is alendronate (claim 3), about 10-80 mg of alendronate per week or about 1-15 mg of alendronate per day is administered to the subject (claim 4), bout 35-70 mg per week of alendronate or about 5-10 mg per day of alendronate is administered to the subject (claim 5), wherein less than 35 mg per week of alendronate or less than 5 mg per day of alendronate is administered to the subject (claim 6), wherein about 10-30 mg per week of alendronate or about 1-4 mg per day of alendronate is administered to the subject (claim 7), and the alendronate is administered orally, intravenously, intraperitoneally, or subcutaneously (claim 8).
However, regarding a bisphosphonate and the bisphosphonate is alendronate, risedronate, ibandronate, zoledronic acid, denosumab, raloxifene, or bazedoxifene, and the bisphosphonate is alendronate (claims 1-3), before the effective filing date of the invention, Brenner et al. teach treating a systemic bone disease by administering a bisphosphonate, the bisphosphonate is alendronate (See for example, p. 1 paragraphs [0007], [0008] and [0011]).
Regarding claims 4-7, about 10-80 mg of alendronate per week or about 1-15 mg of alendronate per day is administered to the subject, about 35-70 mg per week of alendronate or about 5-10 mg per day of alendronate is administered to the subject, less than 35 mg per week of alendronate or less than 5 mg per day of alendronate is administered to the subject, about 10-30 mg per week of alendronate or about 1-4 mg per day of alendronate is administered to the subject, Brenner et al. teach administering alendronate dosages from 3.12, 6.24, …, 49.96 mg per day/per person (See for example, p. 2 1st paragraph).
Regarding claim 8, Brenner et al. teach wherein the alendronate is administered orally, intravenously, intraperitoneally, or subcutaneously (oral administration, oral tablets) (See for example, p. 2 paragraphs [0015] and [0017]).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention knowing that alendronate was being used to treat systemic bone disease (as taught by Brenner et al.), would have been motivated to modify the method taught by Trajkovski et al. and add bisphosphonate, i.e., alendronate to the composition being administered in the method of treating a disease in a mammalian subject with a reasonable expectation of success in administering to the mammalian subject a therapeutically relevant amount of a composition comprising a Parabacteroides goldsteinii, wherein the composition is delivered to the gastrointestinal system of the mammalian subject, and a bisphosphonate, because Trajkovski et al. teach a method of treating a disease in a mammalian subject, comprising administering to the mammalian subject a therapeutically relevant amount of:(i) a composition comprising a Parabacteroides goldsteinii, wherein the composition is delivered to the gastrointestinal system of the mammalian subject, wherein the disease is metabolic disease or disorder or a bone disease, and because Brenner et al. teach treating a systemic bone disease by administering a bisphosphonate, the bisphosphonate is alendronate.
B)
Claims 1, 9-15, 17-29, 32-39, 45, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Trajkovski et al. (WO 2020/069282 A1) and Brenner et al. (US 2001/0021705 A1) as applied to claims 1, 9-13, 21-29, 32-39, 45, 47 and 48 above, and further in view of Rutala et al. (Emerg Infect Dis. 2001 Mar-Apr;7(2):348-53).
The teachings of Trajkovski et al. and Brenner et al. with respect to the limitations of claims 1, 9-13, 21-29, 32-39, 45, 47 and 48 were discussed above.
Trajkovski et al. do not teach Parabacteroides goldsteinii has been inactivated via exposure to a peroxide (claim 14), peroxide is hydrogen peroxide-or hydrogen peroxide vapor (claim 15), the Parabacteroides goldsteinii has been inactivated via exposure to radiation or ionizing radiation (claim 17), the ionizing radiation comprises or consists of light having a wavelength of about 400-420 nm (claim 18), the inactivated Parabacteroides goldsteinii has been inactivated via exposure to air plasma, ultrasound under pressure, an alcohol, high hydrostatic pressure (HHP), or pulsed electric field (PEF) (claim 19), the alcohol is ethanol (claim 20).
However, before the effective filing date of the invention Rutala et al. teach inactivation methods including via exposure to hydrogen peroxide-or hydrogen peroxide vapor, via exposure to radiation or ionizing radiation, via an alcohol, via radiation, etc. (See for example, p. 351 right-hand column 4th paragraph, and p. 352 Table 7 “Technology”, and p. 349 right-hand column 3rd paragraph). Therefore, the inactivation method applied to inactivate the Parabacteroides goldsteinii being administered in the method taught by Trajkovski et al. would have been optimizable by a person of ordinary skill in the art before the effective filing date of the invention by applying known and available inactivation techniques taught by the prior art.
C)
Claims 1, 9-13, 21-29, 32-39, 40, 45, 47and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Trajkovski et al. (WO 2020/069282 A1) and Brenner et al. (US 2001/0021705 A1) as applied to claims 1, 9-13, 21-29, 32-39, 45, 47 and 48 above, and further in view of TW 1640314B (English translation, 2018, 6 pages of PDF).
The teachings of Trajkovski et al. and Brenner et al. with respect to the limitations of claims 1, 9-13, 21-29, 32-39, 45, 47 and 48 were discussed above.
Trajkovski et al. do not teach the metabolic disease or disorder is obesity, type 2 diabetes, fatty liver disease, glucose intolerance, insulin resistance, post-menopausal weight gain, post-menopausal glucose intolerance, or dyslipidemia (claim 40).
However, regarding claim 40, TW 1640314B teach using Parabacteroides goldsteinii to treat metabolic disease or disorder including type 2 diabetes (See for example, p. 1 Abstract and p. 2).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to apply the teachings of TW 1640314B and apply the method taught by prior art to treat a metabolic disease including type 2 diabetes, because TW 1640314B teach using Parabacteroides goldsteinii to treat metabolic disease or disorder including type 2 diabetes.
D)
Claims 1, 9-13, 21-29, 32-39, 45, 47-49, 53 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Trajkovski et al. (WO 2020/069282 A1) and Brenner et al. (US 2001/0021705 A1) as applied to claims 1, 9-13, 21-29, 32-39, 45, 47, 47 and 48 above, and further in view of Yamamoto et al. (Br J Pharmacol. 2012 Jun;166(3):1084-96).
The teachings of Trajkovski et al. and Brenner et al. with respect to the limitations of claims 1, 9-13, 21-29, 32-39, 45, 47 and 48 were discussed above.
Trajkovski et al. do not teach the method further comprises enterically administering spermine and/or spermidine to the subject (claim 49), and the composition comprises spermine and/or spermidine, and the Parabacteroides goldsteinii are cultured or expanded in a medium comprising spermidine or spermine prior to inactivation (claim 53).
However, regarding claims 49, 53, and 55, Yamamoto et al. teach supplementation of spermine or spermidine is beneficial as therapy of metabolic bone disease including osteoporosis both in vitro and in vivo (See for example, p. 1084 4th paragraph, p. 1085 left-hand column 2nd paragraph, and p. 1904 right-hand column 3rd paragraph).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention, knowing that supplementation of spermine and/or spermidine is beneficial as therapy of metabolic bone disease including osteoporosis, and beneficial both in vitro and in vivo (as taught by Yamamoto et al.). would have been motivated to apply the teachings of prior art and further modify the method taught by prior art (combined teachings of Trajkovski et al. and Brenner et al.) and further administer spermine or spermidine to the composition being administer in the method taught by prior art or add the spermidine or spermine to the culture medium of Parabacteroides goldsteinii prior to inactivation with a reasonable expectation of success in providing the claimed method of claims 52, 53 and 55. Because, Trajkovski et al. teach a method of treating a disease in a mammalian subject, comprising administering to the mammalian subject a therapeutically relevant amount of a composition comprising a Parabacteroides goldsteinii, wherein the composition is delivered to the gastrointestinal system of the mammalian subject, wherein the disease is metabolic disease or disorder or a bone disease, because Brenner et al. teach treating a systemic bone disease by administering a bisphosphonate, the bisphosphonate is alendronate, and because Yamamoto et al. teach supplementation of spermine or spermidine is beneficial as therapy of metabolic bone disease including osteoporosis both in vitro and in vivo.
Double Patenting Rejection:
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.
A)
At least claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 11,541,083 B2 in view of and Brenner et al. (US 2001/0021705 A1).
Claim 1 of U.S. Patent No. 11,541,083 B2 disclose/teach a method of treating a bone disease in a mammalian subject, comprising administering a pharmaceutical or probiotic composition to the gastrointestinal system of the subject; wherein the composition comprises an effective amount of an inactivated Parabacteroides goldsteinii; and wherein the bone disease is osteoporosis.
Regarding a bisphosphonate not taught by claim 1 of U.S. Patent No. 11,541,083 B2.
Therefore, a person of ordinary skill in the art before the effective filing date of the invention knowing that alendronate was being used to treat systemic bone disease (as taught by Brenner et al.), would have been motivated to modify the method taught by claim 1 of U.S. Patent No. 11,541,083 B2, and add bisphosphonate, i.e., alendronate to the composition being administered in the method of treating a disease in a mammalian subject with a reasonable expectation of success in administering to the mammalian subject a therapeutically relevant amount of a composition comprising a Parabacteroides goldsteinii, wherein the composition is delivered to the gastrointestinal system of the mammalian subject, and a bisphosphonate, because at least claim 1 of U.S. Patent No. 11,541,083 B2 disclose/teach a method of treating a bone disease in a mammalian subject, comprising administering a pharmaceutical or probiotic composition to the gastrointestinal system of the subject; wherein the composition comprises an effective amount of an inactivated Parabacteroides goldsteinii; and wherein the bone disease is osteoporosis, and because Brenner et al. teach treating a systemic bone disease by administering a bisphosphonate, the bisphosphonate is alendronate.
B)
At least claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 11,883,447 B2 in view of and Brenner et al. (US 2001/0021705 A1).
Claim 1 of U.S. Patent No. 11,883,447 B2 teach/disclose a method for treating a metabolic disease or disorder in a mammalian subject, comprising administering a composition to the gastrointestinal system of the subject, wherein the composition comprises the therapeutically effective amount of inactivated Parabacteroides goldsteinii.
Regarding a bisphosphonate not taught by claim 1 of U.S. Patent No. 11,883,447 B2.
Therefore, a person of ordinary skill in the art before the effective filing date of the invention knowing that alendronate was being used to treat systemic bone disease (as taught by Brenner et al.), would have been motivated to modify the method taught by claim 1 of U.S. Patent No. 11,883,447 B2, and add bisphosphonate, i.e., alendronate to the composition being administered in the method of treating a disease in a mammalian subject with a reasonable expectation of success in administering to the mammalian subject a therapeutically relevant amount of a composition comprising a Parabacteroides goldsteinii, wherein the composition is delivered to the gastrointestinal system of the mammalian subject, and a bisphosphonate, because at least claim 1 of U.S. Patent No. 11,883,447 B2 teach/disclose a method for treating a metabolic disease or disorder in a mammalian subject, comprising administering a composition to the gastrointestinal system of the subject, wherein the composition comprises the therapeutically effective amount of inactivated Parabacteroides goldsteinii, and because Brenner et al. teach treating a systemic bone disease by administering a bisphosphonate, the bisphosphonate is alendronate.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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