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 5 and 24 have been canceled. Claims 1-3, 21, 22 and 23 have been amended. Claims 37-40 have been added. Claims 1-3, 6-11, 13, 14, 17-23, and 25-40 are pending and under consideration.
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.
The rejection of claims 2 and 23 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for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, for reasons of record, is withdrawn in light of applicant’s amendment.
Claims 1-3, 6-11, 13, 14, 17-23, 25-36 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.
Claims 1-3, 21 and 22 have been amended to incorporate the limitation that the liquid crystal or composition thereof does not comprise a polymer. It is unclear if applicant intends to exclude a polymer additive, such as the polycaprolactone used in a composite in the method of Nasajpou et al (ACS Materials Letters, 2020, Vol.2, pp. 1067-1073, see page 1068, Figure 1A), or if applicant intends to also exclude liquid crystals which are polymers, such as liquid crystal polymers (LCP) and liquid crystal elastomers (LCE). For purpose of examination, “does not comprise a polymer” will be interpreted to exclude the addition of a polymer to the liquid crystal, rather than exclusion of liquid crystals which are polymers.
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.
The rejection of claims 1, 2, 6-11, 17, 19, 22, 23, 25, 26, 27, 28, 30, 33 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nasajpou et al (ACS Materials Letters, 2020, Vol.2, pp. 1067-1073) is withdrawn in light of applicant’s exclusion of a “polymer” from the liquid crystal composition. It is noted that Nasajpou et al uses a cholesteryl liquid crystal within a polycaprolactone network (page 1069, second column, lines 1-4).
Claims 1, 6, 8-11, 13, 14, 17-19, 22, 25, 27-35, 39, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang et al (PNAS, 2002, Vol. 99, pp. 9662-9667, reference of the IDS filed 6/25/2025).
Hwang et al disclose the culture of fibroblasts on cholesterol- oligo-lactic acid crystals, wherein round coverslips were coated with a film of the liquid crystals and placed in multiwell plates for culture at 37 degrees (page 9663, column 1, bottom paragraph and column 2, top paragraph) which meets the limitation of culturing at least one anchorage dependent cell in the presence of a liquid crystal without the addition of a polymer, in claims 1 and 22, the anchorage-dependent cell which is a fibroblast in claims 6 and 25, the cholesteryl ester liquid crystal in claims 8 and 27, and the cholesteryl ester liquid crystal based scaffold in claims 19 and 35, coating the surface of a substrate with the liquid crystal in claims 17, 33, and 39 wherein the substrate is a multi-well plate in claims 18, 34 and 40. It is noted that the intended use of “multiplexed bioassays” in claims 18, 34 and 40 has no patentable weight when comparing to the prior art because it fails to impart any structural requirements to the multiwell plate. Hwang et al disclose that the chemical structure of C-Lan (page 9663, Figure 1) which meets the limitations of a cholesteryl ester liquid crystal based scaffold in claims 19 and 35, the substrate in claims 10, 29 Hwang et al disclose that the fibroblast cells were incubated at 37 degrees and then dissociated with 0.25% trypsin (page 9663, second column, lines 1-6) which meets the limitations of claims 13 and 31, and enzymatic treatment in claims 14 and 32.. Hwang et al disclose that C-LA10 has a glass transition temperature of 32 degrees (page 9663, Table 1 and Figure 3) which meets the limitation of claims 11, 22 and 39 for a phase change between 17 degrees and about 42 degrees. Hwang et al disclose that C-LA10 exhibits a liquid crystalline state at 37 degrees (page 9664, first column, lines 14-16 of the first full paragraph), Thus, incubation of the fibroblast cells on C-LA10 at 37 degrees meets the limitation of inducing a phase change in claims 1, and 30 because the C-LA10 substrate would have been initially at room temperature. Hwang et al disclose that C-LA10 comprises a highly interdigitated bilayer with spacing of 58 Ang (page 9664, Figure 4), thus meeting the limitation of a pattern that control cellular organization in claims 9, and 28.
Hwang et al do not disclose that the induction of a phase change results in cellular aggregation, but it would be inherent in the properties of the cholesteryl ester liquid crystal of Hwang et al that cells growing on the liquid crystal would form aggregates on C-LA10 when in the liquid crystalline state because hat is a property taught by the instant specification. Thus, the method of Hwang et al is inherently a method of manufacturing a 3D aggregate required as the method objective in claims 1, 22, and 39.
Claims 1, 6, 8-11, 13, 14, 17-19, 22, 25, 27-35, 39, and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Turiv et al (Science Advances, 2020, Vol,. 6, 10 pages, reference of the IDS filed 6/25/2025) as evidenced by Ware et al (U.S 2026/0062518).
Turiv et al disclose the culture of fibroblasts on a liquid crystal elastomer (LCE) coated on a glass plate (page 1, line 1 under results to page 2, first column, line 7 and page 2, second column, lines 1-2 of the bottom paragraph) which meet the limitation of culturing at least one anchorage dependent cell in the presence of a liquid crystal in claims 1, 22 and 39 and specifically fibroblast cells in claims 6 and 25.. Turiv et al disclose that the LCE is formed from the diacrylate monomer, RM257, which is spin-coated on the glass substrate with a photoinitiator and allowed to polymerize at room temperature (page 8, first column, lines 3-9), which meets the limitation of coating a surface of a cell-culture plate with a liquid crystal in claims 17, 33, and 39 and a liquid-crystal based scaffold in claims 19, 35.. Turiv et al disclose a pattern azo dye layer as a template for the RM527 (page 1, lines 1-7 under “Results”) which meets the limitations of a “substrate” in claims 10, 19, 29, and 35. Turiv et al disclose that the patterned azo dye causes the LCE coating to develop a non-flat profile which influences the cellular organization (page 2, lines 3-10, page 3, second column, lines 1-2 of the first full paragraph and third full paragraph and page 4, second column, lines 2-4) which meets the limitations of claims 9, 19, 28. Turiv et al disclose that the fibroblast cells were cultured at 37 degrees C (page 8, lines 1-3 under the heading “Cell Plating”).
Ware et al provide evidence that a LCE comprising RM257 monomers undergoes a phase change between 30 degrees C and 42 degrees C (abstract, paragraph [0022] and claim 3 of ‘518). Thus, placing the culture dish comprising the plated cells at room temperature into the incubator at 37 degrees causes a phase change of the liquid crystal, which meets the limitations of “inducing a phase change” in claims 1, 30, and a phase change between about 17 degrees and about 42 degrees in claims 11, 22 and 39.
Turiv et al do not disclose that the induction of a phase change results in cellular aggregation, but it would be inherent in the properties of the liquid crystal of Turiv et al that the fibroblast cells growing on the liquid crystal would form aggregates on the RM527 LCE when in the liquid crystalline state because that is a property taught by the instant specification. Thus, the method of Turiv et al is inherently a method of manufacturing a 3D aggregate required as the method objective in claims 1, 22, and 39.
The provisional rejection of claims 1-3, 6-11, 17-23, 25-30, and 33-36 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 10-18 and 20-23 of copending Application No. 18/006,321 in view of Nasajpou et al (ACS Materials Letters, 2020, Vol.2, pp. 1067-1073, reference of the IDS filed 6/25/2025), Cai et al (Cells, April 2022, Vol. 11, Article 1436, 16 pages) and Roder et al (Journal of Functional Biomaterials, 2015, Vol. 6, pp. 1054-1063) is withdrawn in light of applicant’s Terminal Disclamer.
The rejection of claims 1-3, 6-11, 17, 19, 21, 22, 23, 25, 26, 27, 28, 30, 33 and 35 under 35 U.S.C. 103 as being unpatentable over Nasajpou et al (ACS Materials Letters, 2020, Vol.2, pp. 1067-1073) in view of Cai et al (Cells, April 2022, Vol. 11, Article 1436, 16 pages);
the rejection claims 1-3, 6-11, 13, 14, 17, 19, 21, 22, 23, 25, 26, 27, 28, 30-33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Nasajpou et al and Cai et al as applied to claims 1-3, 6-11, 17, 19, 21, 22, 23, 25, 26, 27, 28, 30, 33 and 35 above, and further in view of Seeto (WO2022/115295, cited in the prior action); and
the rejection of claims 1, 2, 6-11, 17, 19, 22, 23, 25, 26, 27, 28, 30, 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Nasajpou et al (ACS Materials Letters, 2020, Vol.2, pp. 1067-1073) in view of Roder et al (Journal of Functional Biomaterials, 2015, Vol. 6, pp. 1054-1063)
is withdrawn in light of applicant amendment of claims 1, 21, 22 to exclude polymer.
All other rejections and/or objections as set forth or maintained in the prior Office action are withdrawn in light of applicants amendment requiring that the liquid crystal composition does not require a polymer
Claims 37 and 38 are allowed.
Conclusion
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 KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643