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 .
Priority
This application claims priority to CN202310296615.2 (3/24/2023) as reflected in the filing receipt issued on 11/1/2023.
The certified copies of the foreign priority documents are not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The disclosure does not enable one of ordinary skill in the art to practice the invention without access to the specific biological material, which is critical or essential to the practice of the invention but not included in the claims. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
The invention appears to employ novel biological materials, specifically: Bifidobacterium
longum subsp. infantis BLl-02, deposited under accession number CGMCC 15212; Lactobacillus acidophilus TYCA06 deposited under accession number CGMCC 15210; Lactobacillus plantarum LPL28 deposited under accession number CGMCC 17954, and Lactobacillus salivarius subsp. salicinius AP-32 deposited under accession number CCTCC M 2011127. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirement of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
While there is a statement in the specification that the bacteria are known and readily available to the public (Specification p. 15 para. 51), as well as deposit letters for each of the strains filed 8/21/2023, not all enablement requirements under 35 U.S.C. § 112(a) appear to be satisfied.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by the applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strains have been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and a receipt showing that the appropriate biological material was received and entered into the depository, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. 1.801-1.809 applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number indicating that:
a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
d) a test of the viability of the biological material at the time the deposit was made and that such test result indicated that said biological material was viable (see 37 C.F.R. 1.807); and;
e) the deposit will be replaced if it should ever become inviable.
A statement regarding deposition and acceptance under the Budapest Treaty and a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon issuance of a patent; or a statement including (a)-(e) above, is required to satisfy the conditions set forth in 35 U.S.C. § 112(a).
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 5-6 and 8-9are 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.
Claims 5 and 8 recite “wherein the liquid culture is free of cells”. This limitation is unclear. As commonly understood, a “liquid culture” comprises cells grown in a liquid media. The specification states that the culture of the bacterial strain is obtained by culturing the bacterial strain in a liquid or solid medium suitable for growth or proliferation, indicating that the liquid culture contains cells. The specification further recites that the liquid culture which is free of cells is obtained by subjecting a culture formed after culturing the lactic acid bacterial strain to a solid-liquid separation (see Specification p. 7 para. 24, p. 9 para. 33). Thus, it appears that a culture which is free of cells refers to the culture medium, or supernatant, wherein the cells have been removed, such as by a separation process, and a “culture” would be considered to contain cells grown in a medium. For clarity, it is suggested that the claims be amended to use a different term, for example supernatant, which more clearly indicates the absence of cells. See Specification Example 1, which refers to the cell culture supernatant, or pg. 29 para. 78 which refers to “cell culture supernatant without bacterial cells”.
Additionally, claim 5 depends on claim 4, which depends on base claim 1; and claim 8 depends on claim 7, which depends on claim 2. Claims 1 and 2 require cultures of Bifidobacterium longum subsp. infantis, along with additional bacterial cultures recited in claim 2. Therefore, claims 5 and 8 require these bacteria. For this reason, it is unclear how the cultures of claims 5 and 8, which are required to include bacterial cells based on their dependency on claims 1 and 2, could be free of cells.
Claims 6 and 9 recite “wherein the culture contains bacterial cells only”. It is unclear what is meant by this, as a culture necessarily contains other components in addition to the bacterial cells, such as the culture media. If there are no components present aside from the bacterial cells, for example if a cell pellet is obtained by removing the liquid media from a culture, this bacterial cell pellet is not itself considered a culture, as a culture requires both cells and media. A culture that contains bacterial cells only could also be interpreted to mean, for example, that the culture contains no other cell types besides the bacterial cells (for example, no yeast cells); or that the culture contains only a single bacterial strain, i.e. a pure culture. However, it is unclear what is meant based on the current claim language. It is suggested that the claims be amended to clarify specifically what is meant by a culture that comprises bacterial cells only.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., US 2021/0275612 A1, in view of Biao Liu et al., CN112823647A.
Regarding claim 1, Liu teaches a method for alleviating an inflammation-related disorder comprising administering to a subject in need thereof a composition containing a culture of at least one lactic acid bacterial strain (Liu p.1 para. 10-11). Liu teaches that the composition may comprise Bifidobacterium longum subsp. infantis BLI-02 (BCRC 910812) as one of the lactic acid bacterial strains (Liu p. 3 para. 51). The instant specification, p. 16 Table 1, indicates that Bifidobacterium longum subsp. infantis BLI-02 CGMCC 15212 is the same as BCRC 910812. Thus, Liu teaches administering a composition comprising Bifidobacterium longum subsp. infantis BLI-02 deposited under accession number CGMCC 15212.
Regarding claims 2 and 3, Liu teaches that the lactic acid bacterial strain of the composition is Lactobacillus plantarum LPL28 which is deposited at the China General
Microbiological Culture Collection Center (CGMCC) under an accession number CGMCC 17954 (Liu p. 2 para. 20) and further comprises Lactobacillus acidophilus TYCA06 (BCRC 910813, same as CGMCC 15210, see instant specification p. 16 Table 1), and Lactobacillus salivarius
subsp. salicinius AP-32 (BCRC 910437, same as CCTCC M 2011127, see instant specification p. 16 Table 1), and Bifidobacterium longum subsp. infantis BLl-02 (Liu p. 3 para. 51).
Regarding claims 4 and 7, Liu teaches that the culture of the lactic acid bacterial strains is a liquid culture (Liu p. 2 para. 36).
Regarding claims 5 and 8, Liu teaches that the liquid culture is completely free of the bacterial cells (Liu p. 2 para. 38).
Regarding claims 6 and 9, Liu teaches that the liquid culture may have a total bacterial concentration not greater than 109 CFU/mL (Liu p. 2 para. 37), or may be substantially free of lactic acid bacterial cells wherein remaining cells do not have a measurable effect on the properties of the liquid culture (Liu p. 2 para. 38). Therefore, Liu teaches a liquid culture comprising bacterial cells. Liu further teaches that the culture of the lactic acid bacterial strain is prepared by culturing the at least one lactic acid bacterial strain in a liquid or solid medium suitable for growth and/or proliferation thereof (Liu p. 2 para. 25). There is no teaching to indicate that any other cell types are present, and thus a skilled artisan could reasonably expect that this culture comprises bacterial cells only.
Regarding claim 11, Liu teaches that the composition may further comprise an additive including calcium carbonate (Liu p. 3 para. 45). The instant specification, p. 11 para. 39, states that examples of calcium supplements include calcium carbonate.
Regarding claim 12, Liu teaches that the composition may be formulated as a food product (Liu p. 3 para. 43) or as a pharmaceutical composition (Liu p. 3 para. 46).
Regarding claim 13, Liu teaches that the composition may be formulated into a suitable
dosage form for oral or topical administration (Liu p. 3 para. 47).
Liu does not teach that the composition is administered for increased calcium absorption to a subject in need thereof as recited in claim 1; or that the subject suffers from a calcium-deficiency disorder as recited in claim 10.
Regarding claim 1, Biao teaches administering a composition comprising probiotic bacterial strains for improving or promoting the absorption and utilization of calcium in subjects in need thereof (Biao p. 5 para. 7). Biao teaches that these strains include Bifidobacterium infantis and Bifidobacterium longum (Biao p. 5 para. 8).
Regarding claim 10, Biao teaches that the composition is administered to ensure adequate nutrition, which is essential during critical periods of height growth, and that low mineral content can lead to delayed bone density growth and stunted height growth in adolescents (Biao p. 2 para. 2). Thus, Biao teaches that the subjects are suffering from calcium deficiency.
It would have been obvious to a skilled artisan, before the effective filing date, to combine the teachings of Liu and Biao to arrive at a method of increasing calcium absorption by administering a composition including a culture of Bifidobacterium longum subsp. infantis BLI-02. Liu teaches administering a composition comprising this strain to a patient. Biao teaches that a strain of the same species, B. infantis, can be administered for increasing calcium absorption. Thus, it would have been obvious to a skilled artisan that the composition taught by Liu, comprising a B. infantis strain, could be administered for the same purpose of increasing calcium absorption as the B. infantis composition taught by Biao.
A person of ordinary skill in the art would have been motivated to modify the teachings of Liu and administer the composition for increasing calcium absorption, because increasing the absorption of calcium by a patient having a calcium deficiency can prevent issues such as low bone density and stunted growth (Biao p. 2 para. 2). It would therefore be considered advantageous to utilize the composition of Liu, which Liu teaches can be administered therapeutically, for a different disorder such as calcium deficiency which can cause various health issues.
A skilled artisan would have a reasonable expectation of success in making this modification to the method of Liu and administering the composition for increasing calcium absorption because it is established in the art as taught by Biao that probiotic strains, including strains of the same species, Bifidobacterium infantis, as those taught by Liu, are successfully utilized in compositions for increasing calcium absorption. Thus, a skilled artisan could reasonably expect that a composition as taught by Liu, also comprising Bifidobacterium infantis and other probiotic bacteria, could be administered for this same purpose. Further, Liu teaches that the specific bacterial strains (BLI-02, TYCA06, LPL28, and AP-32 can be safely administered to a subject as a treatment, and thus a skilled artisan could expect success in administering these strains to a subject to increase calcium absorption.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 11969450 in view of Liu et al., US 2021/0275612 A1, in view of Biao et al., CN112823647A.
Regarding instant claim 1, claim 1 of ‘450 recites a method comprising administering a composition containing Bifidobacterium longum subsp. infantis BLI-02, CGMCC 15212.
Regarding instant claims 12-13, claims 3-5 of ‘450 recite that the composition is a food or pharmaceutical, administered as an oral dosage form, a parenteral dosage form, and a topical dosage form.
The invention of the instant claims and ‘450 differ in that ‘450 does not recite administering the composition for increasing calcium absorption in a subject in need thereof (instant claims 1, 10, 11), the additional bacterial strains in instant claims 2-3; or that the culture is a liquid culture free of cells or comprising only bacterial cells (instant claims 4-9). However, these features are taught by Liu and Biao.
Regarding instant claim 1, Liu teaches a method for alleviating an inflammation-related disorder comprising administering to a subject in need thereof a composition containing a culture of at least one lactic acid bacterial strain (Liu p.1 para. 10-11). Liu teaches that the composition may comprise Bifidobacterium longum subsp. infantis BLI-02 (BCRC 910812) as one of the lactic acid bacterial strains (Liu p. 3 para. 51). The instant specification, p. 16 Table 1, indicates that Bifidobacterium longum subsp. infantis BLI-02 CGMCC 15212 is the same as BCRC 910812. Thus, Liu teaches administering a composition comprising Bifidobacterium longum subsp. infantis BLI-02 deposited under accession number CGMCC 15212.
Regarding claims 2 and 3, Liu teaches that the lactic acid bacterial strain of the composition is Lactobacillus plantarum LPL28 which is deposited at the China General
Microbiological Culture Collection Center (CGMCC) under an accession number CGMCC 17954 (Liu p. 2 para. 20) and further comprises Lactobacillus acidophilus TYCA06 (BCRC 910813, same as CGMCC 15210, see instant specification p. 16 Table 1), and Lactobacillus salivarius
subsp. salicinius AP-32 (BCRC 910437, same as CCTCC M 2011127, see instant specification p. 16 Table 1), and Bifidobacterium longum subsp. infantis BLl-02 (Liu p. 3 para. 51).
Regarding instant claims 4 and 7, Liu teaches that the culture of the lactic acid bacterial strains is a liquid culture (Liu p. 2 para. 36).
Regarding instant claims 5 and 8, Liu teaches that the liquid culture is completely free of the bacterial cells (Liu p. 2 para. 38).
Regarding instant claims 6 and 9, Liu teaches that the liquid culture may have a total bacterial concentration not greater than 109 CFU/mL (Liu p. 2 para. 37), or may be substantially free of lactic acid bacterial cells wherein remaining cells do not have a measurable effect on the properties of the liquid culture (Liu p. 2 para. 38). Therefore, Liu teaches a liquid culture comprising bacterial cells. Liu further teaches that the culture of the lactic acid bacterial strain is prepared by culturing the at least one lactic acid bacterial strain in a liquid or solid medium suitable for growth and/or proliferation thereof (Liu p. 2 para. 25). There is no teaching to indicate that any other cell types are present, and thus a skilled artisan could reasonably expect that this culture comprises bacterial cells only.
Regarding claim 11, Liu teaches that the composition may further comprise an additive including calcium carbonate (Liu p. 3 para. 45). The instant specification, p. 11 para. 39, states that examples of calcium supplements include calcium carbonate.
Regarding instant claim 1, Biao teaches administering a composition comprising probiotic bacterial strains for improving or promoting the absorption and utilization of calcium in subjects in need thereof (Biao p. 5 para. 7). Biao teaches that these strains include Bifidobacterium infantis and Bifidobacterium longum (Biao p. 5 para. 8).
Regarding instant claim 10, Biao teaches that the composition is administered to ensure adequate nutrition, which is essential during critical periods of height growth, and that low mineral content can lead to delayed bone density growth and stunted height growth in adolescents (Biao p. 2 para. 2). Thus, Biao teaches that the subjects are suffering from calcium deficiency.
It would have been obvious for a skilled artisan to combine ‘450 with the teachings of Liu and Biao, arriving at a method of administering the claimed bacterial strains for increasing calcium absorption. Biao teaches that B. infantis and B. longum are both used in a composition for this purpose. It would have been obvious to a skilled artisan that the composition as recited in ‘450 could be administered for the purpose of increasing calcium absorption, as this is a known function of Bifidobacterium infantis as taught by Biao, and would have been motivated to do so given the need for ensuring adequate calcium absorption in subjects suffering from calcium deficiency.
Liu teaches administering a composition comprising infantis BLI-02, in addition to other probiotic strains TYCA06, LPL28, AP-32, and with an additional calcium supplement. Thus, it would have been obvious to a skilled artisan to additionally include these strains in a composition comprising BLI-02. Further, Liu teaches that the cultures can be formulated as liquid cultures and can be free of cells or comprise only bacterial cells. Liquid compositions as claimed are known in the art as taught by Liu, and therefore a skilled artisan would have found it obvious to formulate the composition of ‘450 as a liquid culture for administration.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11957722 in view of Liu et al., US 2021/0275612 A1, in view of Biao et al., CN112823647A.
Regarding instant claim 1, claim 1 of ‘722 recites a method comprising administering a composition containing Bifidobacterium longum subsp. infantis BLI-02, CGMCC 15212.
The invention of the instant claims and ‘722 differ in that ‘722 does not recite administering the composition for increasing calcium absorption in a subject in need thereof (instant claims 1, 10, 11), the additional bacterial strains in instant claims 2-3; or that the culture is a liquid culture free of cells or comprising only bacterial cells (instant claims 4-9), or that the composition is a food or pharmaceutical administered orally, parenternally, or topically (instant claims 12-13). However, these features are taught by Liu and Biao.
The teachings of Liu and Biao regarding claims 1-11 are set forth above.
Regarding instant claim 12, Liu teaches that the composition may be formulated as a food product (Liu p. 3 para. 43) or as a pharmaceutical composition (Liu p. 3 para. 46).
Regarding instant claim 13, Liu teaches that the composition may be formulated into a suitable dosage form for oral or topical administration (Liu p. 3 para. 47).
It would have been obvious for a skilled artisan to combine ‘722 with the teachings of Liu and Biao, arriving at a method of administering the claimed bacterial strains for increasing calcium absorption. Biao teaches that B. infantis and B. longum are both used in a composition for this purpose. It would have been obvious to a skilled artisan that the composition as recited in ‘722 could be administered for the purpose of increasing calcium absorption, as this is a known function of Bifidobacterium infantis as taught by Biao, and would have been motivated to do so given the need for ensuring adequate calcium absorption in subjects suffering from calcium deficiency.
Liu teaches administering a composition comprising infantis BLI-02, in addition to other probiotic strains TYCA06, LPL28, AP-32, and with an additional calcium supplement. Thus, it would have been obvious to a skilled artisan to additionally include these strains in a composition comprising BLI-02 as recited in ‘722. Further, Liu teaches that the cultures can be formulated as liquid cultures and can be free of cells or comprise only bacterial cells, and are formulated as pharmaceutical or food compositions for oral or topical delivery. Liquid compositions formulated as claimed are known in the art as taught by Liu, and therefore a skilled artisan would have found it obvious to formulate the composition of ‘722 as a liquid culture. Pharmaceutical and food compositions are known formulations for administering bacterial compositions, as taught by Liu, and it would have been obvious to use such a formulation in the administration technique of ‘722.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11779615 in view of Liu et al., US 2021/0275612 A1, in view of Biao et al., CN112823647A.
Regarding instant claims 1 and 2, claims 1 and 2 of ‘615 recite a method comprising administering a composition containing Lactobacillus acidophilus TYCA06, CGMCC 15210, and Bifidobacterium longum subsp. infantis BLI-02, CGMCC 15212.
Regarding instant claim 12, claim 1 of ‘615 recites that the composition comprises a physiologically acceptable excipient, i.e. a pharmaceutical composition.
The invention of the instant claims differs from ‘615 in that ‘615 does not recite administering the composition for increasing calcium absorption in a subject in need thereof (instant claims 1, 10, 11), the additional bacterial strains in instant claims 2-3; or that the culture is a liquid culture free of cells or comprising only bacterial cells (instant claims 4-9), or that the composition is administered orally, parenternally, or topically (instant claim 13). However, these features are taught by Liu and Biao.
The teachings of Liu and Biao regarding claims 1-11 and 13 are set forth above.
It would have been obvious for a skilled artisan to combine ‘615 with the teachings of Liu and Biao, arriving at a method of administering the claimed bacterial strains for increasing calcium absorption. Biao teaches that B. infantis and B. longum are both used in a composition for this purpose. It would have been obvious to a skilled artisan that the composition as recited in ‘615 could be administered for the purpose of increasing calcium absorption, as this is a known function of Bifidobacterium infantis as taught by Biao, and would have been motivated to do so given the need for ensuring adequate calcium absorption in subjects suffering from calcium deficiency.
Liu teaches administering a composition comprising infantis BLI-02, in addition to other probiotic strains, LPL28 and AP-32, and with an additional calcium supplement. Thus, it would have been obvious to a skilled artisan to additionally include these strains in a composition comprising BLI-02 and TYCA06 as recited in ‘615. Further, Liu teaches that the cultures can be formulated as liquid cultures and can be free of cells or comprise only bacterial cells, and are formulated as pharmaceutical or food compositions for oral or topical delivery. Liquid compositions formulated as claimed are known in the art as taught by Liu, and therefore a skilled artisan would have found it obvious to formulate the composition of ‘615 as a liquid culture. Oral or topical delivery of pharmaceutical and food compositions are established methods for administering bacterial compositions, as taught by Liu, and it would have been obvious to use such a technique in the administration of the composition recited in ‘615.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 10-12 of copending Application No. 18/444,872 in view of Liu et al., US 2021/0275612 A1, in view of Biao et al., CN112823647A.
Regarding instant claims 1-3, claim 7 of ‘872 recites administering a composition comprising Lactobacillus salivarius subsp. salicinius AP-32 strain, a Lactobacillus plantarum LPL28 strain, a Bifidobacterium longum subsp. infantis BLI-02 strain, and a Lactobacillus acidophilus TYCA06 strain.
Regarding instant claims 12-13, claims 10-12 of ‘872 recite that the composition is a medicine or food, administered orally or topically.
The invention of the instant claims and ‘872 differ in that ‘872 does not recite administering the composition for increasing calcium absorption in a subject in need thereof (instant claims 1, 10, 11) or that the culture is a liquid culture free of cells or comprising only bacterial cells (instant claims 4-9). However, these features are taught by Liu and Biao.
The teachings of Liu and Biao regarding instant claims 1, 4-9, and 10-11 are set forth above.
It would have been obvious for a skilled artisan to combine ‘872 with the teachings of Liu and Biao, arriving at a method of administering the claimed bacterial strains for increasing calcium absorption. Biao teaches that B. infantis and B. longum are both used in a composition for this purpose. It would have been obvious to a skilled artisan that the composition as recited in copending ‘872 could be administered for the purpose of increasing calcium absorption, as this is a known function of Bifidobacterium infantis as taught by Biao, and would have been motivated to do so given the need for ensuring adequate calcium absorption in young children.
Liu teaches a composition comprising the same strains as ‘872, with an additional calcium supplement. Further, Liu teaches that the cultures can be formulated as liquid cultures and can be free of cells or comprise only bacterial cells. Liquid compositions as claimed are known in the art as taught by Liu, and therefore a skilled artisan would have found it obvious to formulate the composition of ‘872 as a liquid culture.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-13 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653