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 1,3-4,7-11 are under examination
Response to Applicants Arguments/Amendments
The amendments have modified the claimed invention. Therefore, the former prior art rejections are withdrawn and a new rejection is put forward. Because amendments were made to claims 4 and 7, the claim objection has been withdrawn.
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 1,3-4,7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 20220340864) in view of Ng “Chlorella vulgaris Extract as a Serum Replacement that Enhances Mammalian Cell Growth and Protein Expression” Frontiers of Bioengineering and Biotechnology, September 2020, Volume 8.
Shimizu discloses culturing separated cells by using a composition comprising chlorella extract (Page 9, Examples 3 and 4, and Figures 7-8). Shimizu discloses that the cell is a bovine-derived muscle cell (Page 9, Examples 3 and 4) as in instant claim 1.
Shimizu does not specifically teach the concentration of chlorella extract recited in the claims. However, Ng teaches that mammalian cells can be cultured in a chlorella extract that is 23.0 g/L or less (Page 9, Figure 7, and the description of Figure 7). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the chlorella extract concentration taught by Ng in the culture process discussed in Shimizu. An artisan would have been motivated to have used the chlorella extract concentration taught by Ng because Ng teaches that it can successfully culture mammalian cells and promote their growth (Page 9, Figure 7, and the description of Figure 7 of Ng). There would have been a high expectation for success because Ng teaches that the claimed range of chlorella extract in the claims can successfully be used to culture mammalian cells (Page 9, Figure 7, and the description of Figure 7) as in instant Claims 1 and 3.
Dependent Claims taught by Shimizu
Shimizu discloses that the chlorella is Chlorella vulgaris (Page, Examples 3 and 4) as in instant Claim 4. Shimizu discloses that the culture medium comprises FBS serum (Page 9; Examples 3-4 and Figures 7-8) as in instant Claims 7-8. Shimizu disclose wherein the serum is comprised in an amount of 0.5 parts by volume to 15 parts by volume based on 100 parts by volume of total volume of the composition (Figure 7-8) as in instant Claim 9. Shimizu discloses wherein the serum is comprised at a weight ratio of 1000:1 to 1:1 relative to the chlorella extract (serum: chlorella extract) (Figure 7-8) as in instant Claim 10. The muscle cells cultured that are mentioned in Examples 3-4 and Figures 7-8 of Shimizu would be considered a type of meat as in instant Claim 11.
Dependent Claims taught by Ng
Ng discloses that the chlorella extract is obtained from Chlorella vulgaris (Abstract of Ng) as in instant Claim 4. Ng discloses wherein the composition comprises serum (Page 9, Figure 7 of Ng) as in instant Claim 7. Ng discloses wherein the serum is FBS (fetal bovine serum) (Page 9, Figure 7 of Ng) as in instant Claim 8. Ng discloses wherein the serum is comprised in an amount of .5 part by volume to 15 parts by volume based on 100 parts by volume of a total volume of the composition (Page 9, Figure 7 of Ng) as in instant Claim 9. Ng discloses wherein the serum is comprised at a weight of 1000:1 to 1:1 relative to the chlorella extract (serum: chlorella extract) (Page 9, Figure 7) as in instant Claim 10.
Shimizu teaches that bovine muscle cells can be successfully cultured in a culture medium containing Chlorella vulgaris extract. Shimizu does not teach the claimed concentration of Chlorella vulgaris extract that can be used; however, Ng teaches that when culturing mammalian cells, it is preferred to use culture medium with an amount of Chlorella vulgaris extract of 23 g/L or less (Figure 7 of Ng). In fact the viability graft of Ng is very similar to Figure 2 (viability graft) of applicants specification. An artisan would have been persuaded to have used desirable concentrations shown in Ng because Ng shows what concentrations of Chlorella vulgaris are desirable and produce the highest cell viability when culturing mammalian cells. Thus, an artisan would have been motivated to have used the concentrations of Chlorella vulgaris shown in Figure 7, Page 9 of Ng that produced the highest viability with the bovine muscle culture medium taught by Shimizu. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicant’s invention, it must be considered, absent evidence to the contrary, that the skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were know in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predicable results to one of ordinary skill in the art at the time of the invention (See KSR International Col. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture. Therefore, the level of ordinary skill in the art is high.
Conclusion
All claims stand rejected.
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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638