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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/04/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: it is suggest a “.” be placed after the term each on line 2. Appropriate correction is required.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-20 and 7 of copending Application No. 2021/0180028 A1 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the claims of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Application 18/230,206
Application No. 2021/0180028 A1
1. A system for 3D cell culture comprising: a microfluidic droplet-generating device and a tunable cell culture material comprising a thiol-acrylate hydrogel.
16. A system for 3D cell culture comprising: a microfluidic droplet-generating device and a thiol- acrylate hydrogel.
2. wherein the microfluidic droplet-generating device comprises a droplet trapping array located below a microfluidic flow channel, wherein the trapping array comprises a plurality of circular traps.
17. wherein the microfluidic droplet - generating device comprises a droplet trapping array located below a flow channel, wherein the trapping array comprises a plurality of circular traps.
3. wherein the circular traps have a diameter of about 70 µm to about 300 µm.
18. wherein the circular traps have a diameter of about 70 µm to about 300 µm.
4. wherein the thiol-acrylate hydrogel is a product of a reaction between a thiol comprising ethoxylated trimethylolpropane tri (3-mercapto-propionate) (ETTMP), and an acrylate comprising poly(ethylene glycol) diacrylate (PEGDA); and wherein the reaction is a base-catalyzed Michael addition occurring at a pH of about 7.6 to 8.2.
19. wherein the thiol - acrylate hydrogel is a product of a reaction between a thiol comprising ethoxylated trimethylolpropane tri ( 3-mercapto-propionate) (ETTMP), and an acrylate comprising poly (ethylene glycol) diacrylate (PEGDA); and wherein the reaction is a base-catalyzed Michael addition occurring at a pH of about 7.6 to 8.2.
5. wherein the thiol-acrylate hydrogel and cells are provided to the microfluidic droplet-generating device in an aqueous phase, and the reaction completes polymerization inside a trapping array.
20. wherein the thiol-acrylate hydrogel and cells are provided to the microfluidic droplet generating device in an aqueous phase, and the reaction completes polymerization inside the trapping array.
10. wherein: when a hydrogel weight percent is about 8.5 and a molar ratio is about 1.0, a gelation time is about 150 minutes; when the hydrogel weight percent is about 8.5 and the molar ratio is about 1.05, the gelation time is about 40 minutes; when the hydrogel weight percent is about 9 and the molar ratio is about 1.0, the gelation time is about 80 minutes; when the hydrogel weight percent is about 9 and the molar ratio is about 1.05, the gelation time is about 30 minutes; when the hydrogel weight percent is about 9.5 and the molar ratio is about 1.0, the gelation time is about 30 minutes; and when the hydrogel weight percent is about 9.5 and the molar ratio is about 1.05, the gelation time is about 25 minutes.
7. wherein: when the hydrogel weight percent is about 8.5 and the molar ratio is about 1.0 , the gelation time is about 150 minutes; when the hydrogel weight percent is about 8.5 and the molar ratio is about 1.05, the gelation time is about 40 minutes; when the hydrogel weight percent is about 9 and the molar ratio is about 1.0, the gelation time is about 80 minutes; when the hydrogel weight percent is about 9 and the molar ratio is about 1.05, the gelation time is about 30 minutes; when the hydrogel weight percent is about 9.5 and the molar ratio is about 1.0, the gelation time is about 30 minutes; and when the hydrogel weight percent is about 9.5 and the molar ratio is about 1.05, the gelation time is about 25 minutes.
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kersker (High-Throughput Assessment of a Novel, Thiol-Acrylate Hydrogel for Tumor Spheroid Synthesis in a Microfluidic Device, LSU Master's Theses, 11-28-2018). This reference was published more than one year prior to Applicants provisional filing date of 12/11/19.
Regarding claim 1, Kersker teaches a system for 3D cell culture (the hydrogel formed a natural 3D shape while inside the 96-well plate, paragraph 3, line 5) comprising: a microfluidic droplet-generating device (microfluidic device, page 21, paragraph 2, lines 9-10, Fig. 2.5) and a tunable cell culture material comprising a thiol-acrylate hydrogel (the thiol-acrylate hydrogel was highly tunable, page 3, paragraph 2, line 14).
Regarding claim 2, Kersker teaches wherein the microfluidic droplet-generating device (microfluidic device, page 21, paragraph 2, lines 9-10, Fig. 2.5) comprises a droplet trapping array located below a microfluidic flow channel (the Leica SP8 confocal microscope includes 96-well ultra-low attachment plates, page 15, paragraph 1, paragraph 1, lines 1-2), wherein the trapping array comprises a plurality of circular traps (the traps designed to capture the droplets were on a second layer of the device, and droplets are trapped when they rise due to surface tension in the aqueous phase, page 20, paragraph 1, lines 11-12; further, Fig. 2.5, right image shows a plurality of circular traps).
Allowable Subject Matter
Claims 7-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 7, the prior art fails to teach or fairly suggest wherein the trapping array has about 785 circular traps having a diameter of 70 µm each, where this is in combination with the claim as a whole.
The closest prior art is Kersker (High-Throughput Assessment of a Novel, Thiol-Acrylate Hydrogel for Tumor Spheroid Synthesis in a Microfluidic Device, LSU Master's Theses, 11-28-2018. Kersker teaches a hydrogel which is prepared by a base-mediated (NaOН), Michael addition between ethoxylated trimethylolpropane tri(3-mercapto-propionate) (ETTMP) having a molecular weight of 1300 g/mol and poly(ethylene glycol) diacrylate (PEGDA) having a molecular weight of 700 g/mol (Scheme 1.2 and Table 1). The hydrogel has tunable properties including, but not necessarily limited to, stiffness (section 1.3), gelation time (Table 1.2), swelling ratio (figure 1), and modulus (section 1.5.8) and can therefore be referred to as a tunable hydrogel. However, Kersker does not explicitly teach wherein the trapping array has about 785 circular traps having a diameter of 70 µm each.
The following is a statement of reasons for the indication of allowable subject matter: for claim 8, the prior art fails to teach or fairly suggest wherein the trapping array has about 990 circular traps having a diameter of 150 µm each, where this is in combination with the claim as a whole.
The closest prior art is Kersker (High-Throughput Assessment of a Novel, Thiol-Acrylate Hydrogel for Tumor Spheroid Synthesis in a Microfluidic Device, LSU Master's Theses, 11-28-2018. Kersker teaches a hydrogel which is prepared by a base-mediated (NaOН), Michael addition between ethoxylated trimethylolpropane tri(3-mercapto-propionate) (ETTMP) having a molecular weight of 1300 g/mol and poly(ethylene glycol) diacrylate (PEGDA) having a molecular weight of 700 g/mol (Scheme 1.2 and Table 1). The hydrogel has tunable properties including, but not necessarily limited to, stiffness (section 1.3), gelation time (Table 1.2), swelling ratio (figure 1), and modulus (section 1.5.8) and can therefore be referred to as a tunable hydrogel. However, Kersker does not explicitly teach wherein the trapping array has about 990 circular traps having a diameter of 150 µm each.
The following is a statement of reasons for the indication of allowable subject matter: for claim 9, the prior art fails to teach or fairly suggest wherein the trapping array has about 450 circular traps having a diameter of 300 pm each, where this is in combination with the claim as a whole.
The closest prior art is Kersker (High-Throughput Assessment of a Novel, Thiol-Acrylate Hydrogel for Tumor Spheroid Synthesis in a Microfluidic Device, LSU Master's Theses, 11-28-2018. Kersker teaches a hydrogel which is prepared by a base-mediated (NaOН), Michael addition between ethoxylated trimethylolpropane tri(3-mercapto-propionate) (ETTMP) having a molecular weight of 1300 g/mol and poly(ethylene glycol) diacrylate (PEGDA) having a molecular weight of 700 g/mol (Scheme 1.2 and Table 1). The hydrogel has tunable properties including, but not necessarily limited to, stiffness (section 1.3), gelation time (Table 1.2), swelling ratio (figure 1), and modulus (section 1.5.8) and can therefore be referred to as a tunable hydrogel. However, Kersker does not explicitly teach wherein the trapping array has about 450 circular traps having a diameter of 300 pm each.
The following is a statement of reasons for the indication of allowable subject matter: for claim 10, the prior art fails to teach or fairly suggest wherein the microfluidic droplet-generating device comprises a flat layer having two inlets and an outlet, wherein the flat layer is above a bottom PDMS device layer that includes the microfluidic flow channel and the droplet trapping array, such the that the droplet trapping array is provided below the microfluidic flow channel, where this is in combination with the claim as a whole.
Conclusion
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799