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 .
Applicant’s election without traverse of Group I (claims 1-3, 5-8, 10-18, and 20) and composition species polymer-free in the reply filed on 12/19/2025 is acknowledged.
Upon further consideration and examination of the claims the species have been found to be art recognized equivalents and thus the species restriction requirement has been withdrawn.
Claims 1-3, 5-8, 10-18 and 20-23 are currently pending.
Claims 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
Claims 1-3, 5-8, 10-18 and 20 have been examined on their merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, 10-11, 13-16, and 18 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hegmann et al (US 2019/0111185-from IDS filed 06/25/2025).
Regarding claims 1-3, Hegmann discloses a method of inducing cell-culturing comprising culturing at least one cell on the surface of a liquid crystal or a composition thereof (page 1 para 7, page 12, para 99-100). Elastomers were seeded with mouse skeletal C2C12 myoblast cells or hDFs cells and cultured; (page 12, para 98 wherein various different cholesteric liquid crystal elastomers are crosslinked and form a matrix or scaffold; page 10, para 85 Such elastomeric materials form a substrate i.e. a scaffold for growing cells therein).Hegmann discloses wherein the cell is selected from the group consisting of an epithelial cell, endothelial cell, muscle cell, neuron, adipocyte, and any combination thereof (pages 10-11 Table 2, page 12 para 97).
Regarding claim 6, Hegmann discloses wherein the liquid crystal is a cholesteryl ester liquid crystal (page 10 para 82, schemes 1 and 2, subsequently a non-toxic, biocompatible liquid crystal is attached to the star block copolymer to one or more of the halide substituted lactone blocks). Suitable biocompatible liquid crystals include any cholesteryl liquid crystal or derivatives thereof such as cholesteryl-5-hexynoate (pages 3-6, para 55-56, wherein scheme 1 includes a cholesteryl ester liquid crystal).
Regarding claim 7, Hegmann discloses wherein the composition comprises at least one selected from the group consisting of a polymer, solvent, composite, substrate, and additive (page 10 para 82, schemes 1 and 2, a non-toxic, biocompatible liquid crystal is attached to the star block copolymer to one or more of the halide substituted lactone blocks).
Regarding claim 8, Hegmann wherein the polymer is a fibrous network (page 15, para 124, polymer network; page 10, para 84). The crosslinked copolymers that form the cell scaffolds of the present invention can be made wherein the crosslinking occurs ... via electrospinning; Electrospinning is a versatile technique for the production of small-diameter fibers). Hegmann discloses wherein the polymer is selected from the group consisting of an edible polymer, food grade polymer, biocompatible polymer, biodegradable polymer, and any combination thereof (page 3 para 51, biodegradable polymers based on poly(ε-caprolactone)).
Regarding claims 10-11, Hegmann discloses wherein the polymer is selected from the group consisting of polyester, polycaprolactone, polyethylene glycol, and any combination thereof (page 3 para 51 specifically poly(ε-caprolactone), page 13 para 110-111).
Regarding claim 13, Hegmann discloses wherein the composition comprises the polymer and the solvent and wherein the composition is generated by dispersing the liquid crystal and the polymer in the solvent (page 1 para 7, The scaffolds comprise lactone and lactide-based star block copolymers having generally a cholesterol-based liquid crystal as a side-group. The scaffold material is blended with salt crystals of a specific desired size and crosslinked... to obtain liquid crystal elastomers that have a porous tailor-made architecture once the salt is removed by leaching with water or other suitable solvent).
Regarding claim 14, Hegmann discloses wherein the composition is generated by: (a) dispersing the liquid crystal and the polymer in the solvent (page 1, para 7). The scaffolds comprise lactone and lactide-based star block copolymers having generally a cholesterol-based liquid crystal as a side-group. The scaffold material is blended with salt crystals of a specific desired size and crosslinked ... to obtain liquid crystal elastomers that have a porous tailor-made architecture once the salt is removed by leaching with water or other suitable solvent and (b) electrospinning the liquid crystal with the polymer (page 10 para 84, The crosslinked copolymers that form the cell scaffolds of the present invention can be made wherein the crosslinking occurs... via electrospinning).
Regarding claim 15, Hegmann wherein the composition is a cholesteryl ester liquid crystal-based scaffold (page 10, para 82, As set forth in Schemes 1 and 2, subsequently a non-toxic, biocompatible liquid crystal is attached to the star block copolymer to one or more of the halide substituted lactone blocks ... Suitable biocompatible liquid crystals include... any cholesteryl liquid crystal or derivatives thereof such as cholesteryl-5-hexynoate; pages 3-6, para 55, Scheme 1; wherein scheme 1 includes a cholesteryl ester liquid crystal; page 10, para 85, The above-noted block star copolymer containing various liquid crystals thereon... are flexible ... Accordingly, they are generally referred to as liquid crystal elastomers. Such elastomeric materials form a substrate i.e. a scaffold).
Regarding claim 16, Hegmann discloses wherein the composition is a nonwoven cholesteryl ester liquid crystal-based scaffold (page 10, para 84, The crosslinked copolymers that form the cell scaffolds of the present invention can be made wherein the crosslinking occurs... via electrospinning; page 12, para 93, final elastomer has fully interconnected pores, i.e. an open pore network; the major obstacle with the use of electrospun scaffolds is the lack of control of its pore size ... This is due to nature of the electrospinning process that randomly deposits layers of non-woven fibers on each other; page 3, para 43, A conventional electrospun scaffold as shown in FIG. 33 shows a highly porous network of non-woven submicron fibers in a planar orientation).
Regarding claim 18, Hegmann discloses wherein the composition is selected from the group consisting of a pharmaceutical composition, edible composition, scaffold, and any combination thereof (page 1, para 7, The scaffolds comprise lactone and lactide-based star block copolymers having generally a cholesterol-based liquid crystal as a side-group).
Therefore, the teaching of Hegmann anticipates Applicant’s invention as claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hegmann et al (US 2019/0111185-from IDS filed 06/25/2025) in view of Cioca et al (US 4,999,348-from IDS filed 06/25/2025).
Regarding claim 5, Hegmann discloses the method of claim 1, but Hegmann fails to explicitly disclose wherein the liquid crystal comprises at least one selected from the group consisting of cholesteryl oleyl carbonate, cholesteryl pelargonate, and cholesteryl benzoate.
Cioca is in the art of liquid crystal (Abstract) and teaches cholesteryl oleyl carbonate and cholesteryl benzoate (Col. 3, lines 18-25, Representative cholesteric liquid crystals ... are ... cholesteryl benzoate ... cholesteryl oleyl carbonate, A preferred mixture consists of cholesteryl nonanoate, cholesteryl chloride and cholesteryl oleyl carbonate).
One of ordinary skill in the art would have been motivated to include various cholesteryl liquid crystals, such as cholesteryl oleyl carbonate and cholesteryl benzoate, in the method of Hegmann, because Cioca suggest that these are suitable alternatives for other cholesteryl liquid crystals. One of ordinary skill in the art would have had a reasonable expectation of success because Hegmann and Cioca are both directed to using cholesteryl liquid crystals.
Therefore, the combined teachings of Hegmann et al and Cioca et al render obvious Applicant’s invention as claimed.
Claim(s) 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hegmann et al (US 2019/0111185-from IDS filed 06/25/2025).
Regarding claim 12, Hegmann discloses the method of claim 11, but Hegmann fails to explicitly disclose wherein the composition comprises between about 5% to about 75% (w/v) polycaprolactone.
However, it would have been obvious to one of ordinary skill in the art to modify Hegmann to include wherein the composition comprises between about 5% to about 75% (w/v) polycaprolactone, since where the general conditions of the claim are disclosed in the prior art (Hegmann, page 10, para 80, The star copolymers of the present invention are made by reacting the above-noted polyols having three or more hydroxyl groups, one or more lactones, one or more halide, substituted lactones, or one or more lactides ... Desirably, the lactone branch can contain randomly about 20% to about 45% repeat units ... The number of random repeat units of the halides substituted lactone is about 20% to about 45% ...The number of random repeat units of the lactide block is about 20 %to about 45%; page 3, para 51, poly(e-caprolactone), poly(lactic acid); page 10, para 78, A preferred halide lactone is alpha-bromo E-caprolactone as well as gamma-1-bromo-E-caprolactone), discovering an optimal percentage of polycaprolactone involves only routine skill in the art. The motivation of doing so would be to develop various open pore network (Hegmann, page 12, para 93, The porosity of the liquid crystal elastomer scaffold can be varied as by changing the polymer ratio to salt ratio, as long as the final elastomer has fully interconnected pores, i.e. an open pore network).
Regarding claim 17, Hegmann discloses the method of claim 16, but Hegmann fails to explicitly disclose wherein the composition comprises between about 25 (w/v) to about 50% (w/v) cholesteryl ester liquid crystal.
However, it would have been obvious to one of ordinary skill in the art to modify Hegmann to include wherein the composition comprises between about 25 (w/v) to about 50% (w/v) cholesteryl ester liquid crystal, since where the general conditions of the claim are disclosed in the prior art (Hegmann, page 10, para 82, As set forth in Schemes 1 and 2... a non-toxic, biocompatible liquid crystal is attached to the star block copolymer to one or more of the halide substituted lactone blocks. An amount of liquid crystal is utilized so that the number of liquid crystals desirably is high, for example from about 60% to about 100 % and desirably from about 80% to about 100% replacement of all pendant halide groups. Suitable biocompatible liquid crystals include ... any cholesteryl liquid crystal or derivatives thereof such as cholesteryl-5-hexynoate), discovering an optimal percentage of cholesteryl ester liquid crystal involves only routine skill in the art. The motivation of doing so would be to develop various open pore networks (Hegmann, page 12, para 93).
Therefore, the teaching of Hegmann et al renders obvious Applicant’s invention as claimed.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hegmann et al (US 2019/0111185-from IDS filed 06/25/2025) in view of Brands et al (WO 2008/101051-from IDS filed 06/25/2025).
Regarding claim 20, Hegmann discloses the method of claim 1, but Hegmann fails to explicitly disclose wherein the liquid crystal or the composition thereof is generated via a solvent-free method, polymer-free method, or a combination thereof.
Brands is in the art of electrospinning (Abstract) and teaches solvent-free electrospinning (Title, polymer or oligomer fibers by solvent-free electrospinning (Pg. 2, Ln. 1, rapid melt electrospinning: solvents are not needed).
It would have been obvious to one of ordinary skill in the art to modify Hegmann to include wherein the liquid crystal or the composition thereof is generated via a solvent-free method, polymer-free method, or a combination thereof, since where the general conditions of the claim are disclosed in the prior art (Hegmann, page 10, para 83-84, Subsequent to the formation of the liquid crystal containing block copolymers of the present invention, such block copolymers are crosslinked... wherein the crosslinking occurs... via electrospinning; Brands, Pg. 2, Ln. 1, rapid melt electrospinning: solvents are not needed), generating a liquid crystal-containing composition using solvent-free electrospinning involves only routine skill in the art. The motivation of doing so would be to crosslink a liquid crystal-containing composition using various methods (Hegmann, page 10, para 84, The crosslinked copolymers that form the cell scaffolds of the present invention can be made wherein the crosslinking occurs in a mold, via casting methods, via a spin coating, via electrospinning, 3D printing, and the like).
Therefore, the combined teachings of Hegmann et al and Brands et al renders obvious Applicant’s invention as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, 15, 18, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-11, 13-14, 17-36 of copending Application No. 19/246227 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are also drawn to method of culturing cells on a liquid crystal or a composition thereof and thus anticipate the claims of the current application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-8, 10-18, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-11, 13-14, 17-36 of copending Application No. 19/246227 in view of Hegmann et al (US 2019/0111185-from IDS filed 06/25/2025).
The claims of the copending application are also drawn to a method of culturing cells on a liquid crystal or a composition thereof and include all the limitations of the current application except for wherein the polymer is selected from a group that includes a fibrous network, a biocompatible polymer, polycaprolactone, the use of a polymer and solvent and electrospinning to form a nonwoven scaffold to form the composition, and the use of the composition as a pharmaceutical.
These limitations are taught and suggested by Hegmann as described above and thus rendered obvious to one of ordinary skill in the art as suitable options and modifications for culturing cells with a liquid crystal composition. The optimization of the concentrations of the polymer composition would have been a matter of routine experimentation for one of ordinary skill in the art as well.
This is a provisional nonstatutory double patenting rejection.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-11, 13-14, 17-36 of copending Application No. 19/246227 in view of Brands et al (WO 2008/101051-from IDS filed 06/25/2025).
Regarding claim 20, the copending claims disclose the method of claim 1, but they fail to explicitly disclose wherein the liquid crystal or the composition thereof is generated via a solvent-free method, polymer-free method, or a combination thereof.
Brands is in the art of electrospinning (Abstract) and teaches solvent-free electrospinning (Title, polymer or oligomer fibers by solvent-free electrospinning (Pg. 2, Ln. 1, rapid melt electrospinning: solvents are not needed).
It would have been obvious to one of ordinary skill in the art to modify the copending claims to include wherein the liquid crystal or the composition thereof is generated via a solvent-free method, polymer-free method, or a combination thereof, since where the general conditions of the claim are disclosed in the prior art generating a liquid crystal-containing composition using solvent-free electrospinning involves only routine skill in the art. The motivation of doing so would be to crosslink a liquid crystal-containing composition using various methods.
Therefore, the combined teachings of the copending claims and Brands et al renders obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pham et al., “Electrospinning Process for Manufacture of Multi-layered Structures”, US 8,968,626.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631