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 .
DETAILED ACTION
The instant application is in response to the papers filed on October 30, 2023 of which claims 1-17 were filed, and are currently pending. Therefore, claims 1-17 are currently under examination to which the following grounds of rejection are applicable.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Republic of Korea Patent Application Nos. 10-2021-0040443, 10-2021-0040444, and 10-2021-0040445 all filed on March 29, 2021, and to PCT Application No. PCT/KR2022/004437 filed on March 29, 2022. Receipt is acknowledged of untranslated 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
Thus, the earliest possible priority for the instant application is March 29, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted September 29, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show which assays contain bFGF and which are bFGF-free as described in the specification. For example, Figure 1 and 2 appear to be representing the same information; however, Fig. 1 was conducted with a culture medium supplemented with curcumin and bFGF as opposed to Fig. 2 was conducted with a bFGF-free curcumin culture medium. This issue is found with all the Figures presented in the Drawings filed October 30, 2023.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because the recited abbreviation, “bFGF-free” should be spelled out at the first encounter in the claims. Appropriate correction is required.
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.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 is directed to “uses”. This claim is indefinite since it is not clear which statutory category the claim is directed to, and therefore, the metes and bounds cannot be determined accordingly. In the case the claim is directed to a process, the claim does not set forth any clear steps involved in the method/process; as it is unclear what method/process applicant is intending to encompass.
Secondly, if the claim is directed to a product/composition, the extent of the scope of the composition remains unclear. For the sake of compact prosecution, the Examiner has interpreted claim 17 to a composition comprising turmeric, glycine, or insulin. If Applicants do not wish for this claim to be interpreted as a composition, Applicants are invited to amend the claims accordingly.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
Claims 1, 10-13, 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”; of record IDS filed on September 29, 2023).
Regarding claim 1, Choi discloses a medium composition for culturing muscle stem cells, having an effect of increasing the growth of muscle stem cells, self-renewal, and differentiation capacity by comprising insulin as a signaling molecule (page 444, and table 3).
Regarding claim 10, dependent on claim 1, Choi describes the muscle stem cells in relation to mice and humans (Table 3).
Regarding claim 11, dependent on claim 1, Choi teaches insulin as maintaining self-renewal, “stemness” characteristics, and reduces their differentiation (Sec. 3.5.3).
Regarding claim 12, dependent on claim 1, Choi teaches various signaling molecules are used to maintain the undifferentiated muscle stem cell state (p 16, col 1; Table 3).
Regarding claim 13, Choi teaches an in vitro culture of muscle stem cells, the method comprising culturing muscle stem cells isolated from a mammal in a culture medium for culturing muscle stem cells, the culture medium comprising insulin (Figure 1 describes this process). Section 2 describes the muscle stem cell isolation from different livestock involving different isolation techniques using different muscle tissues. Section 3 focuses on the culturing methods of these isolated muscle stem cells using different substrates, basal medias, serum/ serum replacements for culturing methods, and cell signaling molecules: cytokines, hormones, and signaling inhibitors which comprises insulin as described in Section 3.5.3.
Regarding claim 15, and claim 16 directed to the product, the rejection to claim 13 is applied herein as the limitations are similar, e.g. muscle stem cells isolated from a mammal” and “muscle stem cells derived from a non-human animal”. The review covers both stem cells isolated from a mammal, and more specifically a non-human animal, and stem cells derived from these animals (“Moreover, Qu-Petersen et al. showed that not only muscle stem cells but also muscle-derived stem cells, a kind of interstitial cells, could be isolated using a 6-step sequential preplating technique (Gharaibeh et al., 2008).” (p 434, col 1; p 447, col 2)). Regarding claim 16, Figure 1 clearly depicts the method of cultured meat production wherein the final product is in vitro meat.
***Regarding claim 17, refer to the 35 USC 112(b) and 35 USC 101 rejections applied above. For the sake of compact prosecution, the “use claim”, as highlighted in MPEP 2173.05(q), is being interpreted as being directed to a composition comprising turmeric, glycine, or insulin for which Choi anticipates as described in Section 3.5.3 as rejected in claim 1. Additionally, if the claim is rather directed to a process, the rejection under Choi is also applied herein as the method of culturing is adequately described (Fig. 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) as applied to claim 1, and further in view of Thaloor et al. (Am. J. Physiol. 1999, vol. 277, pp. C320-C329; of record IDS filed on September 29, 2023).
Regarding claim 1, the disclosure of Choi is applied as in the 102(a)(1) rejections above, the content of which is incorporated above, in its entirety.
Regarding claim 2, dependent on claim 1, Choi teaches a culture medium for muscle stem cells that comprises insulin as applied to the claim 1 rejection, but Choi does not teach this composition as comprising either glycine or turmeric.
Thaloor discloses a medium comprising curcumin has effects on cultured muscle precursor cells, e.g. myoblasts, to directly stimulate both cell proliferation and differentiation (abstract; p 321, col 2; p 324, col 1). Curcumin is a turmeric extract for which the instant Specification describes on page 2, “In an embodiment, the turmeric may be a turmeric extract or a fraction thereof. The turmeric extract or a fraction thereof may include curcumin, demethoxycurcumin, bisdemethoxycurcumin, or the like.”.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated curcumin in the culture medium composition for culturing muscle stem cells as described by Choi based on Thaloor describing the beneficial role curcumin has in cell expansion for muscle stem cells, and therefore there is a reasonable expectation that it would have similar outcomes when similarly culturing muscle stem cells.
Regarding claim 3, dependent on claim 2, Thaloor teaches using the turmeric extract of curcumin for cell culturing of muscle stem cells (abstract).
Regarding claims 4 and 5, the concentration of curcumin is considered routine optimization as a person skilled in the art through repeated experimentation would be able to determine the optimal dosage. Thaloor teaches dosages of curcumin of 10-8, 10-7, 10-6, and 10-5 (Fig 4).
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
Since the prior art of Thaloor teaches the concentration of curcumin during culturing of muscle stem cells can vary, and wherein muscle tissue regeneration is dose- dependent as seen in the highest expression of relevant gene at the highest curcumin dosage of 10 uM (10 -6M), it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art of cell culturing.
Claims 1, 6, 7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) as applied to claim 1, and further in view of Gheller et al. (Molecular Metabolism. 2021 (Available online: 23 October 2020), vol. 43, 101106, pp. 1-15; of record IDS filed on September 29, 2023).
Regarding claim 1, the disclosure of Choi is applied as in the 102(a)(1) rejections above, the content of which is incorporated above, in its entirety.
Regarding claims 6 and 7, dependent on claim 1, Choi teaches a culture medium for muscle stem cells that comprises insulin as applied to the claim 1 rejection, but Choi does not teach this composition as comprising either glycine or turmeric.
Gheller discloses a culture media comprising glycine in various concentrations (10 μM, 100 μM, 1000 μM) that has a proliferative effect on muscle progenitor cells in a dose-dependent manner (abstract; p 2, col 2, “Sec. 2.3”; p 5, col 2, “Sec. 3.1”; and figure 1). Gheller teaches the claimed concentrations of glycine: 0.1 mM to 1,000 mM, and at least 100 µM with the dosages of 100 µM and 1000 µM.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have been motivated to use a concentration of glycine between 0.1 mM to 1,000 mM or at least 100 µM based on Gheller teaching glycine having a proliferative effect on muscle progenitor cells in a dose-dependent manner, and therefore it would be easy to optimize the concentration accordingly. Moreover, it would be obvious to have claimed the glycine concentrations based on Gheller’s teachings encompassing these claimed values for the cell culturing of muscle stem cells with glycine.
Regarding claim 14, dependent on claim 1, Choi teaches that muscle stem cells can be passaged (“The combination of these four cytokines allowed the in vitro maintenance of muscle stem cells in an undifferentiated state over 20 passages.” (Sec. 3.5.7.)), yet this is in view of using cytokines.
Gheller teaches that the muscle progenitor cells (MPCs) were passaged, and that passage 6 was used in all experiments, e.g. treatments with glycine (p 2, col 2). Altogther, it would have been obvious to passage the muscle stem cells in order for adequate amount to be available for downstream applications while ensuring cells are healthy and not stressed as this is routine in the art of cell culturing.
Claims 1, 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (“Comprehensive reviews in food science and food safety 20.1 (2021): 429-457.”) as applied to claim 1, and further in view of Godoy-Parejo et al. (Stem cells 37.8 (2019): 1030-1041).
Regarding claim 1, the disclosure of Choi is applied as in the 102(a)(1) rejections above, the content of which is incorporated above, in its entirety.
Regarding claims 8 and 9 dependent on claim 1, Choi teaches a culture medium for muscle stem cells that comprises insulin as applied to the claim 1 rejection, but Choi does not teach the particular insulin dosages to be used to obtain the observed effects of stem cell proliferation.
Regarding claims 6 and 7, dependent on claim 1, Choi teaches a culture medium for muscle stem cells that comprises insulin as applied to the claim 1 rejection, but Choi does not teach this composition as comprising either glycine or turmeric.
Godoy-Parejo teaches insulin is a hormone commonly used for in vitro stem cell cultures, which promotes stem cell survival and cell spreading on Matrigel-coated surfaces used during cell culturing (abstract; Fig. 1). Godoy-Parejo teaches insulin promoting cell survival at 10 µg/mL (10 µM) (Fig. 3a).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have been motivated to use a concentration of insulin between 0.01 µM to 100 µM or a concentration of at least 10 µM based on Godoy-Parejo teaching insulin promoting cell survival at a minimum dosage of 10 µM for embryonic stem cells (Fig. 3A, p 6, col 1), and therefore the claimed the insulin concentrations are taught by Godoy-Parejo. Additionally, it would be obvious to try in using 10 µM of insulin for culturing muscle stem cells based on Godoy-Parejo teaching culturing with embryonic stem cells, and the outcomes of cell survival/proliferation being observed when using insulin when culturing muscle stem cells as described by Choi.
Conclusion
Claims 1-17 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634