DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 14 November 2025. Claims 1, 5, and 6 have been amended. Claim 4 has been cancelled. Claim 7 remains withdrawn. Claims 1-3, 5, and 6 are currently pending and under examination.
This application is a National Stage of International Application No. PCT/KR2021/003315, filed March 17, 2021, and claims benefit of priority to Korean Patent Application No. 10-2021-0009580, filed January 22, 2021, and Korean Patent Application No. 10-2020-003429, filed March 18, 2020.
Withdrawal of Rejections:
The rejection of claims 4-6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al., is withdrawn.
The rejection of claims 1-3, 5, and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Ouyang et al., is withdrawn.
New Rejections Necessitated by Amendment:
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.
Claims 1-3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (IDS; Tension stimulation drives tissue formation in scaffold-free systems, Nature Materials, Vol. 16, No. 8, (2017), pp. 864-873), and further in view of Goh et al. (US 6,737,053; Published 2004 – previously presented).
With regard to claims 1 and 6, Lee et al. teach a method for preparing fibrocartilage, the method comprising culturing articular chondrocytes under a tensile stimulus (Abs.; p. 874, Left Col., Methods, Application of tension stimulation, Para. 1-4). The cells are cultured under continuous tensile stimulus from days 7-28 during a culture period of 28 days (p. 874, Left Col., Methods, Application of tension stimulation, Para. 4, CoTenS regimen).
While it is further taught in another embodiment that tension is applied for one hour per day during the culture period and then released (p. 874, Left Col., Methods, Application of tension stimulation, Para. 4, InTenS regimen), it is not taught that the tensile stimulus is released following the continuous tensile stimulus and the cells are further cultured for an additional period of 10 days to 28 days under no tensile stimulus.
Goh et al. teach a method of making a tissue-engineered ligament, which is fibrocartilage, the method comprising culturing cells on a sheet immersed in culture medium and applying a cyclic tensile loading stimulus to the sheet and cells seeded thereon (Fig. 19; Col. 3, line 60-62). When tension is released, the sheet assumes a larger diameter permitting fluid to flow in, providing fresh nutrients to the cells within the sheet, and also allows for cells suspended in the fluid to be carried into the interior of the sheet, thus increasing attachment of cells to the interior (Col. 5, line 35-37). The ligament is ready for transplantation into a patient after incubating cells attached to the scaffold sheet, where incubation occurs for a time ranging from one to twelve weeks to allow substantial growth and expansion of cells (Col. 5, line 64 to Col. 6, line 1; Fig. 13). It would have been obvious to one of ordinary skill in the art to utilize a time period within the expressly taught time period of one to twelve weeks (7 to 84 days), which fully encompasses 10 to 28 days, for incubating the sheet after release of tension from the conclusion of cyclic tensile loading, to allow fresh nutrients and cells to flow into the sheet while the engineered ligament is awaiting transplantation.
It would have been obvious to one of ordinary skill in the art to combine the teachings of Lee et al. with Goh et al., because both teach methods of making fibrocartilage by culturing cells under a tensile stimulus. A period of incubation, including 10-28 days, of the engineered fibrocartilage prior to transplantation into a patient, as well as the advantages of releasing the tensile stimulus, is known in the art as taught by Goh et al. One would have been motivated to utilize a period of release of the tensile stimulus following the continuous tensile stimulus of Lee et al. to allow the culture medium and free cells to advantageously flow into the fibrocartilage. Thus, predictably and successfully improving the method by allowing for greater colonization of the entire fibrocartilage construct.
With regard to claim 2, Lee et al. teach that the tensile stimulus is applied from days 10-14 of a 28-day regime (p. 874, Left Col., Methods, Application of tension stimulation, Para. 4), wherein 5 days is fully encompassed within 4 to 10 days.
With regard to claim 3, Lee et al. teach that the tensile stimulus is applied with a force of 12-15% (p. 874, Left Col., Methods, Application of tension stimulation, Para. 4), which is fully encompassed within 5% to 20%.
With regard to claim 5, taken together, Lee et al. and Goh et al. render obvious the method as claimed, utilizing the components as claimed. As such, the method as rendered obvious by Lee et al. and Goh et al. necessarily provides the result of preparing fibrocartilage including intervertebral disc, interpubic disc, and meniscus cartilage.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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, Sharmila G. Landau can be reached at (571)272-0614. 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.
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653