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 1-19 are pending and under examination in the instant application.
Priority
The instant application, filed 07/17/2024 is a national stage entry under 35 USC 371 of PCT/CN2022/075575 (filed 02/09/2022).
Also, 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 parent Application No. CN202210058996.6, filed on 01/19/2022.
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. Thus, the earliest filing priority date is 02/09/2022.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 5, 12, 13, 17, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 4, 12, and 17 contain the trademark/trade name GlutaMax. Where a trademark or trade name is
used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with
the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218
USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used
properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods
associated with the trademark or trade name. In the present case, the trademark/trade name is used to
identify/describe an L-alanyl-L-glutamine dipeptide alternative to L-glutamine and, accordingly, the
identification/description is indefinite.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112779209A, filed on 11/08/2019, and published on 05/11/2021, citations are from the English Translation of CN112779209A), in view of Zielniok et al. (Zielniok et al.,"Functional interactions between 17 β -estradiol and progesterone regulate autophagy during acini formation by bovine mammary epithelial cells in 3D cultures". Biomed Res Int. 2014; 2014:382653) and Montesano et al. (Montesano et al., “Tumour necrosis factor α confers an invasive, transformed phenotype on mammary epithelial cells” J Cell Sci 1 August 2005; 118 (15): 3487–3500).
Regarding claim 1, Liu et al. teaches a cell culture medium for culturing primary mammary epithelial cell (Abstract and claim 1), comprising insulin, basic fibroblast growth factor, and fibroblast growth factor 10 (claims 3-5).
However, Liu et al. fails to teach that the cell culture medium comprises β-estradiol and tumor necrosis factor-α.
However, Zielniok et al. discloses that β-estradiol is added to mammary epithelial cell (MEC) cultures to mimic the hormonal environment of the mammary gland in vivo, where estrogen is a key regulator of development, proliferation, and function (page 13, column 1, paragraph 1). Zielniok et al. also teaches that in the intact mammary gland, E2, controls ductal branching, acinar formation, and alveolar development. Adding E2 to MEC cultures helps recapitulate these processes in vitro, especially in 3D acinar models where hormone signaling is critical for proper morphogenesis (page 2, column 1, paragraph 2).
Furthermore, Montesano et al. discloses that tumor necrosis factor-α can promote proliferation of mammary epithelial cells, particularly in the context of inflammation or genetic. Montesano et al. also teaches TNF‑α stimulates proliferation both in the absence of exogenous mitogens and under anchorage‑independent conditions predisposition (Summary, page 3487, columns 1 and 2). Also, Montesano et al. teaches that in 3D collagen gel cultures, TNF‑α induces scattering and invasion of mammary epithelial cells, which is accompanied by increased cell growth. This effect is linked to the upregulation of matrix metalloproteinase‑9 (MMP‑9) and integrin changes that facilitate migration and survival (Summary, page 3487, columns 1 and 2).
Therefore, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have added β-estradiol and tumor necrosis factor-α to the culture medium of Liu et al. for culturing primary mammary epithelial cell with a reasonable expectation of success. One would have been motivated to have done so as both β-estradiol and tumor necrosis factor-α work as key regulators of development, proliferation, and function of mammary epithelial cells as taught by Zielniok et al. and Montesano et al.
Regarding claims 2 and 3: Following discussion of claim 1 above, Zielniok et al. teaches that 1 nM of β-estradiol was used in the differentiation medium of mammary epithelial cells (page 4, column 1, paragraph 2). Although Zielniok et al. fails to specifically teach that the concentration of β-estradiol is 5nM to 50 nM, it would have been prima facie obvious to one of the ordinary skills in the art before the effective
filing date of the claimed invention to have optimized the amount of β-estradiol in the differentiation medium of mammary epithelial cells of Zielniok et al. to promote proliferation of mammary epithelial cells
such that the concentration of β-estradiol is 5nM to 50 nM with a reasonable expectation of success. One would have been motivated to have done so since Zielniok et al. establishes that the amount of β-estradiol in the differentiation medium of mammary epithelial cells would have only required routine experimentation.
Regarding claim 4: Following discussion of claim 1 above, Liu et al. further teaches that the cell culture medium for culturing primary mammary epithelial cell comprises amphiregulin, epidermal growth factor, insulin, B27, Y27632, neuregulin 1, fibroblast growth factor 7, A8301, and GlutaMAX-I (Examples 1-2, claims 3-4).
Regarding claim 5: Following discussion of claim 4 above, Liu et al. further teaches that the concentration of fibroblast growth factor7 is 5 ng/ml (Table 3), which falls within the claimed range of 2.5 ng/ml to 20 ng/ml.
Regarding claim 6: Following discussion of claim 1 above, Liu et al. further teaches that the culture medium comprises an initial culture medium of DMEM/F12 medium and primocin antibiotic (Table 3).
Regarding claim 7: Following discussion of claim 1 above, Liu et al. further teaches a culture method for culturing mammary epithelial cells comprising a step of culturing primary mammary epithelial cells using the cell culture medium (Abstract and claims 7-9).
Regarding claim 8: Following discussion of claim 7 above, Liu et al. further teaches that the culture method comprises the following steps: (1) preparing the culture medium (2) coating a culture vessel with an extracellular matrix gel (3) inoculating primary mammary epithelial cells in the coated culture vessel and culturing them the cells using the culture medium prepared in step (1) (claim 7).
Regarding claim 9: Following discussion of claim 1 above, Liu et al. further teaches a
method for evaluating or screening drugs for treating breast diseases comprising the following steps: (1) obtaining culturing primary mammary epithelial cells and culturing them using the primary cell culture medium for culturing primary mammary epithelial cells (2) selecting a drug to be tested and preparing the drug in different concentrations (3) adding different concentrations of the drug prepared in step (2) into the mammary epithelial cells obtained from step (1) and (4) detecting the cell viability (Abstract and page 4, paragraphs 9-16).
Regarding claims 10-11, and 15-16: Following discussion of claim 7 above, Zielniok et al. teaches that 1 nM of β-estradiol was used in the differentiation medium of mammary epithelial cells (page 4, column 1, paragraph 2). Although Zielniok et al. fails to specifically teach that the concentration of β-estradiol is 5nM to 50 nM, it would have been prima facie obvious to one of the ordinary skills in the art before the effective
filing date of the claimed invention to have optimized the amount of β-estradiol in the differentiation medium of mammary epithelial cells of Zielniok et al. to promote proliferation of mammary epithelial cells
such that the concentration of β-estradiol is 5nM to 50 nM with a reasonable expectation of success. One would have been motivated to have done so since Zielniok et al. establishes that the amount of β-estradiol in the differentiation medium of mammary epithelial cells would have only required routine experimentation.
Regarding claim 12 and 17: Following discussion of claim 7 above, Liu et al. further teaches that the cell culture medium for culturing primary mammary epithelial cell comprises amphiregulin, epidermal growth factor, insulin, B27, Y27632, neuregulin 1, fibroblast growth factor 7, A8301, and GlutaMAX-I (Examples 1-2, claims 3-4).
Regarding claim 13 and 18: Following discussion of claim 12 above, Liu et al. further teaches that the concentration of fibroblast growth factor7 is 5 ng/ml (Table 3), which falls within the claimed range of 2.5 ng/ml to 20 ng/ml.
Regarding claim 14 and 19: Following discussion of claim 7 above, Liu et al. further teaches that the culture medium comprises an initial culture medium of DMEM/F12 medium and primocin antibiotic (Table 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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