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 .
Claims 1-15 are pending and have been considered on the merits herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 2/25/2026.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 Objections
Claims 1 and 2 are objected to because of the following informalities: it suggested to delete the wording “in accordance with the Budapest Treaty” from claims 1 and 2. Appropriate correction is required.
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 1-15 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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. Since the microorganisms, Lactobacillus plantarum PL-02 deposited with the CGMCC under accession number CGMCC20485, Lactococcus lactis LY-66 deposited with the CGMCC under accession number CGMCC21838 and Bifidobacterium longum subsp. longum OLP-01 deposited with the CGMCC under accession number CGMCC17345, are recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganisms are not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit of the microorganism. The specification does not disclose a repeatable process to obtain the microorganism and it is not apparent if the microorganism is readily available to the public.
If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or a statement by an attorney of record over his/her signature and registration number, stating that the deposit has been made under the Budapest Treaty and that all restrictions imposed by the depositor on availability to the public of the deposited material will be irrevocably removed upon issuance of the patent would satisfy the deposit requirement. See 37 CFR 1.808.
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 and 7 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.
The claims are drawn to liquid cultures which depend from claim 1, which recite a composition including a culture of Lactobacillus, thus the liquid culture would be expected to contain bacterial cells; however, claims 5 and 7 state that the liquid culture is “free of bacterial cells”, thus it is not clear what is in the liquid culture of claims 5 and 7. It is suggested applicant amend the claims to use a term known in the art, for example, “cell culture supernatant”, i.e. “wherein the composition comprises a cell culture supernatant of Lactobacillus…”.
Claim Interpretation
Applicants’ specification does not disclose who would be encompassed within the term “a subject in need thereof” in the claims, i.e. in need of increasing calcium absorption; however, the specification teaches at (0024) “According to the present disclosure, the subject suffers from a calcium deficiency-associated disorder. In certain embodiments, the calcium deficiency-associated disorder may be selected from the group consisting of osteopenia, rickets, joint pain, muscle cramp, hypertension, palpitation, anxiety, obesity, skin inflammation, hypocalcemia, and combinations thereof. (0025) In certain embodiments, the subject may suffer from dysmenorrhea, or be in a perimenopausal, menopausal, or postmenopausal stage, resulting in a calcium deficiency”.
Thus, any of these subjects are interpreted to be a subject in need of increasing calcium absorption.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6, 12, 14, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (Nutrients, vol. 14, p. 1-14, 2022).
Applicants’ specification does not disclose who would be encompassed within the term “a subject in need thereof”, i.e. in need of increasing calcium absorption; however, the specification teaches at (0024) “According to the present disclosure, the subject suffers from a calcium deficiency-associated disorder. In certain embodiments, the calcium deficiency-associated disorder may be selected from the group consisting of osteopenia, rickets, joint pain, muscle cramp, hypertension, palpitation, anxiety, obesity, skin inflammation, hypocalcemia, and combinations thereof. (0025) In certain embodiments, the subject may suffer from dysmenorrhea, or be in a perimenopausal, menopausal, or postmenopausal stage, resulting in a calcium deficiency”.
Thus, any of these subjects are interpreted to be a subject in need of increasing calcium absorption.
Regarding claims 1 and 14, Lin teaches obesity to be a world-wide health problem correlated with many diseases and disorders. Lin teaches administering to obese (HFD) mice, compositions comprising probiotic supplement strains B. longum subsp. longum OLP-01, L. plantarum PL-02 and L. lactic LY-66 (abstract, intro., p. 2 whole page, section 2.1,Table 1) which provide significant health improvements in the subject’s exercise recovery and performance, weight, strength, fatty-acid accumulation, glycogen levels and reduction of serum metabolites.
Regarding claims 4 and 15, the culture is a liquid culture administered via oral gavage (p.3, section 2.3)
Regarding claim 6, the composition included bacterial cells of each of the strains (3, 1st parag.).
Regarding claim 12, the subject is obese, i.e. HFD obesity animal model (p. 2-3, section 2.2) which applicants define as a calcium-deficiency associated disorder.
Thus, the reference anticipates the claimed subject matter, as the subjects are those in need thereof, who are administered the claimed strains, and thus, the strains must necessarily be increasing calcium absorption in the subjects.
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.
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.
Claim(s) 1, 4, 6, 12-15 is/are rejected under 35 U.S.C. 103 as obvious over Cudennec et al. (US20230025631) in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022).
Cudennec teach an L. plantarum strain for administration to a mammal which increases calcium absorption (0001, 0011, 0012, 0014, 0015, 0022, 0028). The references teaches that calcium absorption plays a role in many biological functions including the functioning of muscles and neurons, bone metabolism the cardiovascular system and pathologies including insulin resistance, hypertension, and obesity are associated with calcium deficiencies (0002).
Regarding claim 6, the composition comprises bacterial cells as it contains an amount of the strain measured in CFU (0029, 0030).
Regarding claim 12, the reference teaches that Lactobacilli provide a safe and promising approach to treating hypocalcemia (0008, 0010), hypertension, inflammatory diseases (0019, 0020), osteoporosis, type 2 diabetes, hypertension, cardiac pathologies linked to blood calcium, obesity, metabolic syndrome, cancer, in particular colon cancer, prostate cancer, ovarian cancer, breast cancer, pathologies linked to an alteration in the intestinal metabolism, in particular chronic inflammatory bowel diseases, i.e. calcium-deficiency associated disorders, for use as an immunoregulator or anti-inflammatory drug or for use in the treatment of an abnormal physiological condition linked directly or not to a malfunction of the vitamin D receptor (0022).
Regarding claim 13, the composition contains calcium (0034).
Regarding claim 14, the composition is a food or pharmaceutical (0025-0040).
Regarding claim 15, the composition is administered via oral route (0028, 0029, 0039, 0040).
The claims are drawn to a strain which when administered to a subject in need thereof is intended to increase calcium absorption.
While the cited reference discloses a L. plantarum strain which is taught to increase calcium absorption in a subject in need thereof, the strain is not disclosed to be the claimed L. plantarum PL-02 strain.
However, before the effective filing date of the claimed invention, the claimed L. plantarum PL-02 strain was known, as evidenced by Lin who teaches administering to obese (HFD) mice, i.e. a subject in need of increased calcium absorption, a composition comprising L. plantarum PL-02 (abstract, intro., p. 2 whole page, section 2.1,Table 1).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the prior art teachings to arrive at a method of increasing calcium absorption in a subject in need thereof when administering the known L. plantarum PL-02. The art teaches a strain of the same genus and species, L. plantarum, which is administered to a subject in need of increasing calcium absorption, i.e. having a calcium-deficiency associated disorder, and the claimed strain which is also taught to be administered to a subject in need thereof having a calcium-deficiency associated disorder. Thus, a phosita has a good reason to pursue a known L. plantarum strain within his or her technical grasp, and would have had a reasonable expectation of increasing calcium absorption when using the L. plantarum PL-02 strain of Lin in the method of Cudennec.
Claim(s) 1, 4, 6, 12-15 is/are rejected under 35 U.S.C. 103 as obvious over Chen et al. (US20190321420) in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022).
Regarding claims 1 and 12, Chen teaches administering a composition comprising L. plantarum (0042-0045, 0049, for example) for increasing calcium absorption in a subject in need thereof, i.e. one having a bone disease, particularly osteoporosis (abstract, 0003-0007, 0019-0022, 0046, 0059, 0060, 0070-0072, Table 1 and 2) and having a calcium deficiency disease (0025).
Regarding claims 4 and 6, the culture is a culture solution of rehydrated freeze-dried strains (0054-0058).
Regarding claim 13, the composition comprises a calcium supplement (0032).
Regarding claim 14, the composition is an edible or pharmaceutical composition (0002).
Regarding claim 15, the composition is administered by oral administration as it is an edible composition (0031-0034, 0047).
The cited reference discloses a L. plantarum strain which increases calcium absorption in a subject in need thereof.
The claims are drawn to a strain which when administered to a subject in need thereof is intended to increase calcium absorption.
While the cited reference discloses a L. plantarum strain which is taught to increase calcium absorption in a subject in need thereof, the strain is not disclosed to be the claimed L. plantarum PL-02 strain.
However, before the effective filing date of the claimed invention, the claimed L. plantarum PL-02 strain was known, as evidenced by Lin who teaches administering to obese (HFD) mice, i.e. a subject in need of increased calcium absorption, a composition comprising L. plantarum PL-02 (abstract, intro., p. 2 whole page, section 2.1,Table 1).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the prior art teachings to arrive at a method of increasing calcium absorption in a subject in need thereof when administering the known L. plantarum PL-02. The art teaches a strain of the same genus and species, L. plantarum, which is administered to a subject in need of increasing calcium absorption, i.e. having a calcium-deficiency associated disorder, and the claimed strain which is also taught to be administered to a subject in need thereof having a calcium-deficiency associated disorder. Thus, a phosita has a good reason to pursue a known L. plantarum strain within his or her technical grasp, and would have had a reasonable expectation of increasing calcium absorption when using the L. plantarum PL-02 strain of Lin in the method of Chen.
Claim(s) 1, 2, 4, 6, 12, 14, 15 is/are rejected under 35 U.S.C. 103 as obvious over Kim et al. (J. med. Food, vol. 22, p. 1022-1031, 2019) in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022).
Regarding claims 1, 2, 14, Kim teaches that post-menopausal women typically experience obesity and osteoporosis (p. 1022, intro. 2nd para.). Kim study the effects of probiotic administration to ovariectomized mice. The ovariectomy increases bodyweight and osteoporosis, and induces loss of bone density, as well as decreases calcium, phosphorus and osteocalcin levels (p. 1028, 2nd col., effects of NK3 section), thus a subject in need thereof, and one having a calcium-deficiency associated disorder according to applicants’ specification. Kim teaches that Lactobacillus plantarum and Bifidobacterium longum, when administered to the ovariectomized mice (a menopause model, p. 1025, prep. Of mice with ovariectomy and osteoporosis), effectively alleviated ovariectomy-induced osteoporosis and obesity and increased blood calcium, osteocalcin levels, suppressed bodyweight, alleviated gut inflammation, as well as mitigated anxiety and depression-like behaviors (abstract, p. 1023, 1st full parag., p. 1028, 2nd col.-p. 1029, 1st parag., p. 1030, 1st full parag.).
Regarding claims 4 and 6, the strains/cells are suspended in solution (p. 1023, 2nd col, 1st parag.).
Regarding claim 12, the subject suffers from a calcium-deficiency associated disorder according to applicants’ specification, i.e. osteoporosis, post-menopause and obesity.
Regarding claim 15, the composition is administered orally (p. 1024, Dosage regimen section).
The cited reference discloses a L. plantarum strain which increases calcium absorption in a subject in need thereof.
The claims are drawn to a strain which when administered to a subject in need thereof is intended to increase calcium absorption.
While the cited reference discloses a L. plantarum strain which is taught to increase calcium absorption in a subject in need thereof, the strain is not disclosed to be the claimed L. plantarum PL-02 strain.
However, before the effective filing date of the claimed invention, the claimed L. plantarum PL-02 strain was known, as evidenced by Lin who teaches administering to obese (HFD) mice, i.e. a subject in need of increased calcium absorption, a composition comprising L. plantarum PL-02 (abstract, intro., p. 2 whole page, section 2.1,Table 1).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the prior art teachings to arrive at a method of increasing calcium absorption in a subject in need thereof when administering the known L. plantarum PL-02. The art teaches a strain of the same genus and species, L. plantarum, which is administered to a subject in need of increasing calcium absorption, i.e. having a calcium-deficiency associated disorder, and the claimed strain which is also taught to be administered to a subject in need thereof having a calcium-deficiency associated disorder. Thus, a phosita has a good reason to pursue a known L. plantarum strain within his or her technical grasp, and would have had a reasonable expectation of increasing calcium absorption when using the L. plantarum PL-02 strain of Lin in the method of Kim.
Claim(s) 1-4, 6, 8-15 is/are rejected under 35 U.S.C. 103 as obvious over KR20130002543 in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022).
Regarding claim 1-3, KR20130002543 teaches administering a probiotic composition comprising L. plantarum, L. lactis and B. longum which promotes the absorption of calcium and relieves bone density reduction and osteoporosis (abstract, p.4, whole page, p. 5, last 2 parag.-p. 6, 1st parag.) in ovariectomized mice inducing osteoporosis, calcium deficiency and estrogen deficiency (p. 14, animal design).
Regarding claims 4, 6, 9, the culture is a liquid culture comprising cells (p. 14, 3rd from last parag.).
Regarding claim 8-11, the composition is taught to comprise each of the lactic acid bacteria mixed at equal ratio’s (p. 14, last parag.)
Regarding claim 12, the subject suffers from a calcium-deficiency associated disorder according to applicants’ specification, i.e. osteoporosis.
Regarding claims 13 and 14, the composition additionally comprises a calcium supplement (p. 6, 3rd and 8th parag.) and may be a food, nutraceutical or pharmaceutical composition (p. 6, 7th parag., p. 8, 2nd to last full parag.).
Regarding claim 15, the composition is administered orally (p. 7, 3rd from last parag., p. 8, 3rd parag.).
The cited reference discloses a L. plantarum strain which increases calcium absorption in a subject in need thereof.
The claims are drawn to a strain which when administered to a subject in need thereof is intended to increase calcium absorption.
While the cited reference discloses a L. plantarum strain which is taught to increase calcium absorption in a subject in need thereof, the strain is not disclosed to be the claimed L. plantarum PL-02 strain.
However, before the effective filing date of the claimed invention, the claimed L. plantarum PL-02 strain was known, as evidenced by Lin who teaches administering to obese (HFD) mice, i.e. a subject in need of increased calcium absorption, a composition comprising L. plantarum PL-02 (abstract, intro., p. 2 whole page, section 2.1,Table 1).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the prior art teachings to arrive at a method of increasing calcium absorption in a subject in need thereof when administering the known L. plantarum PL-02. The art teaches a strain of the same genus and species, L. plantarum, which is administered to a subject in need of increasing calcium absorption, i.e. having a calcium-deficiency associated disorder, and the claimed strain which is also taught to be administered to a subject in need thereof having a calcium-deficiency associated disorder. Thus, a phosita has a good reason to pursue a known L. plantarum strain within his or her technical grasp, and would have had a reasonable expectation of increasing calcium absorption when using the L. plantarum PL-02 strain of Lin in the method of KR’543.
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.
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.
Claim(s) 2, 3, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (Nutrients, vol. 14, p. 1-14, 2022) as applied to claims 1, 4, 6, 12, 14, 15 above.
While Lin teaches administering each strain of B. longum subsp. longum OLP-01, L. plantarum PL-02 and L. lactic LY-66 separately, these 3 strains are shown to be most effective overall in the obese subjects. Thus, it would have been obvious to one of ordinary skill in the art to combine the three strains into one probiotic composition for administration to the subject with a reasonable expectation of successfully increasing calcium absorption in a subject having a calcium-deficiency associated disorder, as these subjects would be one in need thereof.
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (J. med. Food, vol. 22, p. 1022-1031, 2019) in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022) as applied to claims 1-4, 6, 8-15 above, and further in view of Liu et al. (US20210275612).
The teachings of Kim are found above. Kim differs from the claimed invention in that they do not teach the culture to be free of bacterial cells.
Regarding claims 5, 7, the use of supernatants in probiotic compositions comprising lactic acid bacteria including Lactobacillus plantarum and Bifidobacterium, specifically, B. longum OLP-01 was known and used in the art before the effective filing date. See Liu, who teach the preparation of liquid cell cultures and their resultant supernatants of lactic acid bacteria strains for administration to a subject (Ex. 1, 0061, 0066, 0067, 0070).
Thus, before the effective filing date of the claimed invention, a posita has good reason to pursue the known options within his or her technical grasp, i.e. using well-known methods to prepare liquid culture solutions which are cell free, with a reasonable expectation of successfully obtaining a cell culture supernatant for administration to a subject.
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (Nutrients, vol. 14, p. 1-14, 2022) as applied to claims 1-4, 6, 9, 12, 14, 15 above, and further in view of Liu et al. (US20210275612).
The teachings of Lin are found above, the reference differs from the claimed invention in that they do not teach the culture to be free of bacterial cells.
Regarding claims 5, 7, the use of supernatants in probiotic compositions comprising lactic acid bacteria including Lactobacillus plantarum and Bifidobacterium, specifically, B. longum OLP-01 was known and used in the art before the effective filing date. See Liu, who teach the preparation of liquid cell cultures and their resultant supernatants of lactic acid bacteria strains for administration to a subject (Ex. 1, 0061, 0066, 0067, 0070).
Thus, before the effective filing date of the claimed invention, a posita has good reason to pursue the known options within his or her technical grasp, i.e. using well-known methods to prepare liquid culture solutions which are cell free, with a reasonable expectation of successfully obtaining a cell culture supernatant for administration to a subject.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over each of Cudennec et al. (US20230025631) in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022) and Chen et al. (US20190321420) in view of Lin et al. (Nutrients, vol. 14, p. 1-14, 2022) as applied to claims 1, 4, 6, 12-15 above, and further in view of Liu et al. (US20210275612).
The teachings of Cudennec and Chen are found above, the references differ from the claimed invention in that they do not teach the culture to be free of bacterial cells.
Regarding claims 5, the use of supernatants in probiotic compositions comprising lactic acid bacteria including Lactobacillus plantarum and Bifidobacterium, specifically, B. longum OLP-01 was known and used in the art before the effective filing date. See Liu, who teach the preparation of liquid cell cultures and their resultant supernatants of lactic acid bacteria strains for administration to a subject (Ex. 1, 0061, 0066, 0067, 0070).
Thus, before the effective filing date of the claimed invention, a posita has good reason to pursue the known options within his or her technical grasp, i.e. using well-known methods to prepare liquid culture solutions which are cell free, with a reasonable expectation of successfully obtaining a cell culture supernatant for administration to a subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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