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 .
Claim Status
Claims 1-3, 8-10, 14, and 16 are amended.
Clam 4 is cancelled.
Claims 1-3,5-10,12-14,16 and 18-22 are under examination.
Withdrawn Rejections
Rejections under - 35 USC § 102
The rejection of claims 1-3,5-7,9-10,12-14, 16, 18-19, and 21 under 35 U.S.C. 102 (a) (1) as being anticipated by Parent et al ( WO 2010/031190 A 1) is withdrawn in view of claims amendments.
Rejections under - 35 USC § 103
The rejections of claim(s) 8, 20, and 22 under 35 U.S.C. 103 as being unpatentable over as being anticipated by Parent et al ( WO 2010/031190 A 1) in view of Schlaeger et al ( Journal of Immunological Methods, 1996), and Murphy et al (Dissertation submitted to Dublin City University, 1986) is withdrawn in view of claims amendment.
New ground of rejections necessitated by claims amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-3,5-7,9-10,12-14, 16, 18-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Parent et al ( WO 2010/031190 A 1), in view of Zeng et al ( Poultry science, 2002).
Regarding claims 1-3, 14, 16, and 18, Parent et al disclose a serum-free culture medium that enables the proliferation of cells of the myogenic lineage, such as muscular stem cell, myoblast, and myoblast-derived cell. (See claims 3 and 31). Parent et al also disclose method of culturing cells of the myogenic lineages in a chemically defined medium, wherein the chemically defined medium is serum free. (See abstract, and claim 30). The culturing medium of Parent et al comprises of basal medium and cytokine. ( See claim 1). According to Parent et al the cytokine comprises of at least one growth factor and one interleukin, wherein the growth factor being FGF-2 and the interleukin being IL-6. ( See claims 14-17, and 21-22). Parent et al also disclose that the chemically defined medium may further contain IGF. ( See claims 19-20).Parent et al disclose that the chemically defined medium also includes a supplement consisting of dexamethasone, bFGF (also known as FGF2), albumin, and insulin. (See claims 24, 29).
Taken together, Parent et al teach a serum-free medium comprising of albumin, FGF2,IL-6, and IGF. However, Parent et al do not teach a serum-free medium that further comprises HGF or PDGF (i.e. claims 1 and 3).
Zeng et al demonstrate that culturing turkey progenitor cells, such as satellite cells, in a serum-free medium comprising either HGF, PDGF,IGF, or bFGF significantly increases the proliferation of turkey satellite cells. (See Fig.8-9). Furthermore, Zeng et al show that the simultaneous exposure of turkey progenitor cells to HGF, PDGF, bFGF, and IGF produced a significant increase in the proliferation of the Late clone (LH91) satellite cell. (See Fig. 9-“ column A”). These findings imply that HGF and PDGF, as well as, bFGF and IGF, play major roles in promoting the proliferation of turkey progenitor cells.
Furthermore, Doumit et al teach that culturing porcine satellite cells, a type of porcine progenitor cell, in basal serum-free medium comprising either bFGF, IGFs, or PDGF-BB significantly induces the proliferation of porcine satellite cells. ( See Fig.2C-D). Doumit et al further show that PDGF-BB enhances porcine progenitor cell proliferation synergistically when combined with IGF-I, bFGF, or EGF. ( See Fig.4). Doumit et al also demonstrate that the simultaneously exposing porcine progenitor cells to bFGF, PDGF-BB, EGF, and IGF-I produced a fivefold increase in cell prefiltration compared to cells grown in basal serum-free medium. ( See Fig.5). In addition, Doumit et al show that the removing EGF did not affect the mitogenic response, whereas removing IGF-I, bFGF, or PDGF-BB reduced proliferation by -40, 20, and 10%, respectively. (See abstract, and Fig.5). These results suggest that both PDGF-BB, as well as bFGF and IGF, play a major role in promoting the proliferation of porcine progenitor cells.
Taken together, claims 1 and 3 would have been obvious to one of ordinary skill in the art at the time the invention was filed, as there was some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill in the art to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Parent et al developed a chemically defined serum-free medium containing albumin, FGF2, IL-6, and IGF that support the growth of bovine myogenic lineage, but fail to teach a medium that further comprises HGH and PDGF. Zeng et al show that the simultaneous exposure of turkey progenitor cells to HGF, PDGF, bFGF, and IGF produced a significant increase in the proliferation of the Late clone (LH91) of the turkey progenitor cells. Doumit et al teach that the simultaneous exposure of porcine progenitor cells to bFGF, PDGF-BB, and IGF-I resulted in a fivefold increase in cell prefiltration compared to cells grown in basal serum-free medium. Thus, the teachings of Zeng and Doumit provide a motivation for one with ordinary skill in the art to supplement the medium of Parent et al with HGF and PDGF to see the effect of these factors on the proliferation of bovine progenitor cells, and an ordinary skill in the art would have a reasonable expectation of success, as doing so would most likely produce a synergistic effect on the proliferation of the bovine progenitor cells.
Regarding claim 5-6, Parent et al disclose that the chemically defined medium comprises of basal medium, wherein the basal medium can be Dulbecco's modified Eagles's medium (DMEM) or Ham's F12. (See claim 9).
Regarding claim 7, Parent et al disclose that the medium also contains lipid, wherein the lipid is linolenic acid. (See claims 26-27).
Regarding claims 9, and 21 Parent et al further disclose that the medium may contain B27 as a supplement, which contains ethanolamine and corticosterone (i.e. hydrocortisone). (See Table 8 page 31, and claim 29).
Regarding claim 10, following the discussion of claims 1 and 3 above, the combined teachings of Parent, Zeng and Doumit render obvious a medium comprising albumin,IL-6, FGF2, IGF, HGF, and PDGF. Furthermore, in one embodiment, Parent et al teach that the medium may further comprises of basal medium, insulin, transferrin, selenite, a lipid, and B27. (See claim 29). It should be noted that the source of glucose and glutamine is already incorporated in the basal medium. (See tables 4-5, page 19-21).
Regarding claim 12-13, Parent et al teach that the chemically defined serum-free medium support the proliferation of the cells of the myogenic lineage at the same rate as another cell of the myogenic lineage cultivated in a standard medium containing serum. (See claims 1 and 30 ).
Regarding claim 19, Parent et al do not disclose that the chemically defined serum-free medium can be utilized to produce a culture-based meat product for human consumption; however, this outcome is presumed to be inherent because the combined teachings of Parent et al, Zeng and Doumit teach the same medium and the same cells as in the instant application.
Claims 8,20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Parent et al, Zeng et al, and Doumit et al as applied to claims 1-3,5-7,9-10,12-14, 16, 18-19, and 21 above, and further in view of in view of Schlaeger et al ( Journal of Immunological Methods, 1996), and Murphy et al (Dissertation submitted to Dublin City University, 1986).
Regarding claim 8 and 22, The teachings of Parent et al, Zeng and Doumit are set forth above, the medium of Parent does not contain protein hydrolysate.
Schlaeger et al teach that the protein hydrolysate, such as Primatone RL, is a low-cost media supplement that, when added to mammalian cell culture media, significantly improves the cell growth properties of many cell lines. Schlaeger et al demonstrate that the addition of protein hydrolysate to the cell culture media containing serum promote cell growth. Schlaeger et al teach that adding protein hydrolysate to a serum-containing media promotes cell proliferation; however this impact is even more pronounced in serum-free culture. Schlaeger et al also demonstrate that the addition of protein hydrolysate to serum-free media increases cell growth by increasing the maximum cell numbers and decreasing cell death. (See abstract, Fig.3-4). Schlaeger et al teach that in an effort to identify a low-cost serum substitute, the group discovered that adding protein hydrolysate, such as Primatone RL, to serum-free medium permits growth to a high cell density, and prolongs the viability of several human and rodent cells in suspension cultures. (See Introduction page 192, right column, 3rd paragraph).
Therefore, it would have been prima facie obvious to one with ordinary skill in the art at the time the invention was filed to combine the teachings of Parent and Schlaeger to develop a chemically defined serum-free media for culturing bovine progenitor cells and supplement it with protein hydrolysate. Parent et al developed a chemically defined serum-free medium containing albumin and FGF2 to support the growth of myogenic lineage, such as muscular stem cell, myoblasts, and myoblasts-derived cells. Schlaeger teaches that adding protein hydrolysate to serum-free media promotes cell growth and reduces cell death. Thus one would have been motivated to culture the bovine progenitor cell in a serum-free medium containing albumin and FGF2 and supplement it with protein hydrolysate. There would be a reasonable expectation of success in doing so because protein hydrolysate is a low-cost media supplement that has been found to significantly improves the cell growth properties of many cell lines, as disclosed by Schlaeger et al. Some Teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143 (I)(G).
Regarding claim 20, The teachings of Parent et al, Zeng et al , and Doumit et al are set forth above, the medium of Parent et al also does not contain ascorbic acid.
Murphy et al disclose a serum-free medium with chemically defined components that support the growth of a human tumor cell line, such as RPMI 2650. Murphy et al teach that ascorbic acid is one of the components utilized in serum-free media formulations, because prior arts have demonstrated that ascorbic acid significantly promotes cell growth when serum is absent. (See table 1.1, page 8, and 2nd paragraph, page 133). Murphy et al further teach that the addition of six components, including ascorbic acid, is sufficient to support the growth of RPMI 2650 cells in the absence of serum. (See abstract). According to Murphy et al, “ the addition of ascorbic acid to a culturing medium is known to enhance collagen synthesis. This may explain the significant proliferation of RMPI 2650 when ascorbic acid was introduced to the culture media”. (See last paragraph on page 134). Given the documented role of ascorbic acid addition to chemically defined serum-free medium to support cell growth; it would have been prima facie obvious to one with ordinary skill in the art at the time the invention was filed to combine the teachings of Parent and Murphy to develop a chemically defined serum-free media for culturing bovine progenitor cells and supplement it with ascorbic acid. Parent et al developed a chemically defined serum-free medium containing albumin and FGF2 to support the growth of myogenic lineage, including muscular stem cell, myoblasts, and myoblasts-derived cells. Murphy et al teach that ascorbic acid is one of the components utilized in serum-free media formulations, as prior arts have shown that ascorbic acid support cell growth. Thus, one would have been motivated to culture the bovine progenitor cell in a serum-free medium containing albumin and FGF2 and supplement it with ascorbic acid. There would be a reasonable expectation of success in doing so because ascorbic acid has been shown to be one of the basic components required to support the growth of different cell types in the absence of serum. Some Teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143 (I)(G).
Response to Arguments
Applicant's arguments/remarks filed 09/08/2025 have been fully considered but they are not persuasive. This is because, as previously noted in the non-final rejection, claim 4 is free of art and that claim 4 will be allowable if fully incorporated in the base claim. However, it is noted that Applicants amended claim 1 to incorporate only IGF and HGF, which are elements encompassed by previous claim 4. Yet, claim 1 as amended is not free of art. Therefore, new ground of rejections have been made to address the amended claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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