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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 December 2025 has been entered.
Claim 1 has been amended. Claims 12-17 remain withdrawn. Claims 1, 5-9, 11, 18, and 19 are currently pending and under examination.
This application is a national phase application under 35 U.S.C. § 371 of International Application No. PCT/US2021/019933, filed February 26, 2021, which claims benefit of priority to U.S. Provisional Application No. 62/082449, filed February 27, 2020.
Withdrawal of Rejections:
The rejection of claims 1, 5-9, 11, 18, and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Das, is withdrawn.
Modified/New Rejections:
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 1, 5-9, 11, 18, and 19 are 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 1 as amended recites in relevant part that the heparin and heparin-bound bFGF are “preferentially patterned on said diboride exposed portions.” The phrase "preferentially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The term “preferentially” appears to indicate a preferred, but not mandatory, limitation. As such, the limitation following this term is deemed to be optional.
Claims 5-9, 11, 18, and 19 are included in this rejection as these claims depend from above rejected claim 1, and fail to remedy the noted deficiency.
Response to Arguments
Applicant urges that the amendments overcome the indefiniteness rejection. Applicant’s arguments have been fully considered, but have not been found persuasive. The newly added limitation is indefinite for the reasons discussed above.
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, 5-9, 11, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Das (IDS; Microfabrication of Titanium Diboride Patterned on Silicon Substrates for Mono- And Coculture of Endothelial and Mesenchymal Stem Cells, May 2014, Dissertation), in view of Industry Academic Cooperation Foundation of Chung Ang University (WO 2017/159943A1, published 2017-09-21, hereafter Chung Ang University; English translation provided by Examiner and referenced hereafter).
With regard to claims 1, 11, and 18, Das teaches a composition comprising a patterned surface comprising a silicon-containing substrate, including Si or SiO2/Si, and diboride in the form of TiB2, patterned on the silicon substrate, where the patterned surface comprises both silicon and diboride exposed portions (Abs.; p. 95, Para. 2; Fig. 6.1(e)). MSCs and HUVECs are cultured using the composition (p. 71, 4.6.3). While it is further taught that heparin is included with growth factors for culture of cells on the substrate of the composition (p. 68, 4.5.1, para. 1 to p. 69, para. 2), it is not taught that the composition further comprises heparin-bound basic fibroblast growth factor (bFGF).
Chung Ang University teach a well-plate for culture of cells, including MSCs, the well-plate including culture medium comprising heparin and a fibroblast growth factor (bFGF)-heparin complex, which is heparin-bound bFGF, the complex providing the growth factor with improved structural stability and cell proliferation effect (Abs.; p. 2, para. 4-5; p. 3, Example 8).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Das and Chung Ang University, because both teach a cell culture substrate for culturing cells, including MSCs, and culture media comprising heparin and growth factors. The inclusion of heparin-bound bFGF on a cell culture substrate is known in the art as taught by Chung Ang University. An ordinary artisan would have been motivated to further include heparin-bound bFGF in the composition of Das, because the complex provides the growth factor with improved structural stability and cell proliferation effect, including for MSCs. As such, the inclusion of bFGF as an additional growth factor bound to heparin would have been expected to predictably improve the composition of Das.
It is noted that that limitation that the heparin and heparin-bound bFGF are “preferentially patterned on said diboride exposed portions” is interpreted to be an optional limitation, as discussed in the indefiniteness rejection above.
With regard to claims 5-7 and 19, Das teaches that the patterned surface comprises one or more TiB2 exposed zones surrounded by exposed silicon regions; the TiB2 zones in the form of geometric shapes including lines, circles, squares, rectangles, and ovals; (see Figs. 6.1(e), 6.7). The square zone having a length/width of 200 µm (see Fig. 6.1(e)), and circles having a diameter of 100 µm to 500 µm (p. 123, 6.1.1.2, line 1-3), which are fully encompassed within 50 to 1000 µm. The diboride exposed zones including, for example, 25 circles (see Fig. 4.2(c)-(d)).
With regard to claims 8 and 9, taken together, Das and Chung Ang University render obvious the composition as claimed, including the components as claimed. As the composition cannot be separated from its properties, the patterned surface is necessarily capable of enabling a 3D microenvironment via cell aggregation; and is necessarily capable of being located in a microwell, on a slide, chip or wafer, or tissue culture flasks.
Response to Arguments
In view of Applicant’s amendments, the previous anticipation rejection has been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653