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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/11/2026 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 9-11, 21, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hohnel et al. (US 2018/0264465 A1) in view of Oakey et al. (US 2017/0145169 A1).
Regarding claim 1, Hohnel et al. teach:
1. An apparatus for isolating a biological material, comprising:
a fluidic channel (e.g., 2) disposed over and affixed to a portion of a substrate (see Figs. 1A-1C for example); and
a patterned hydrogel structure disposed within the fluidic channel (see Figs. 1B-1C for example), the patterned hydrogel structure comprising, in polymerized form, a first photoreactive monomer comprising an acrylate group, the patterned hydrogel structure comprising a plurality of discrete wells (e.g., microwells 3) formed therein (see i.e., microwells 3 in Fig. 1C for example), each discrete well of the plurality of discrete wells having a diameter from about 1 µm to about 500 µm (see ¶ 0095 & Table 1 for example), each discrete well sized to isolate a single cell (see ¶ 0111 & Fig. 11 for example).
Regarding claim 1, Hohnel et al. teach the use of: the first photoreactive monomer comprising the acrylate group (¶ 0050) comprising poly(hydroxy ethyl acrylate), poly(hydroxyethyl methacrylate), or mixtures thereof. However, Hohnel et al. do not explicitly teach: the first photoreactive monomer comprising the acrylate group comprises polyethylene glycol diacrylate.
Oakey et al. teach: An apparatus for isolating a biological material, comprising:
a fluidic channel disposed over a portion of a substrate (see Fig. 1 for example); and
a hydrogel structure disposed in the fluidic channel (Abstract, ¶ 0003-0006+), the hydrogel structure comprising a plurality of wells (see i.e., pores of a composite porous hydrogel ¶ 0012-0020+; pattern porous polyethylene glycol hydrogel network structure ¶ 0005+), wherein each well of the plurality of wells has a diameter from about 1 µm to about 500 µm (see ¶ 0013, 0059+ for example), the hydrogel structure comprising, in polymerized form, a first photoreactive monomer comprising an acrylate group (e.g., PEG-diacrylate (PEGDA) macromer ¶ 0003-0005, 0012+).
wherein one or more wells of the plurality of wells has a diameter from about 30 μm to about 120 μm (see ¶ 0013, 0059+ for example).
wherein one or more wells of the plurality of wells has a diameter from about 5 μm to about 20 μm (see ¶ 0013, 0059+ for example).
wherein one or more wells of the plurality of wells are capable of retaining a cell, tissue, other biological material, or combinations thereof (see i.e., cell encapsulation throughout the reference).
wherein the first photoreactive monomer comprising the acrylate group comprises polyethylene glycol diacrylate (see ¶ 0003-0005, 0012+ for example).
wherein the hydrogel structure further comprises, in polymerized form, one or more thiol linkers (see ¶ 0158, 0164 for example).
wherein the one or more thiol linkers is a polyethylene glycol dithiol linker (see ¶ 0158, 0164 for example).
wherein: the one or more thiol linkers has a molecular weight from about 500 Da to about 10,000 Da; the first photoreactive monomer has a molecular weight from about 250 Da to about 50,000 Da; or a combination thereof (see ¶ 0012, 0158, 0164 for example).
wherein the first photoreactive monomer has a molecular weight from about 200 Da to about 5,000 Da (see ¶ 0012, 0108 for example).
wherein the first photoreactive monomer has a molecular weight from about 200 Da to about 2,000 Da (see ¶ 0012, 0108, 0164 for example).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Hohnel et al. with a photoreactive monomer comprising polyethylene glycol diacrylate, as taught by Oakey et al. (see ¶ 0003-0005, 0012+ for example), since it is well-known that among PEG hydrogel-forming polymers are photopolymerizable acrylates in the form of polyethylene glycol diacrylate (PEGDA) (Oakey et al. ¶ 0003+). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
With regard to limitations in claims 1, 4, 23, 26 (e.g., [...] each discrete well sized to isolate a single cell, [...] to retain the single cell for about 24 hours or more, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claims 2-4, 9, 10, 21, 23, 25, 26, modified Hohnel et al. teach:
2. The apparatus of claim 1, wherein one or more discrete wells of the plurality of discrete wells has a diameter from about 30 µm to about 120 µm (see ¶ 0095 & Table 1 for example).
3. The apparatus of claim 1, wherein one or more discrete wells of the plurality of discrete wells has a diameter from about 5 µm to about 20 µm (see ¶ 0095 for example).
4. The apparatus of claim 1, wherein one or more discrete wells of the plurality of discrete wells are capable of retaining the single cell (see ¶ 0111 & Fig. 11 for example) for about 24 hours or more (¶ 0153).
9. The apparatus of claim 1, wherein the patterned hydrogel structure further comprises, in polymerized form, one or more thiol linkers (see ¶ 0045, 0047 for example).
10. The apparatus of claim 9, wherein the one or more thiol linkers is a polyethylene glycol dithiol linker (see ¶ 0050 for example).
21. The apparatus of claim 1, wherein the plurality of discrete wells are arranged in an array (see Fig. 1C for example).
23. The apparatus of claim 1, wherein the plurality of discrete wells are capable of mimicking in vivo conditions (see ¶ 0059 for example).
25. The apparatus of claim 1, wherein each discrete well of the plurality of discrete wells comprises: a bottom surface; and a wall extending from the bottom surface (see Fig. 1C for example).
26. The apparatus of claim 1, wherein each discrete well of the plurality of discrete wells comprises a morphology capable of isolating biological material (see ¶ 0050, 0155-0156 for example).
Regarding claims 11, 24 & 27, Hohnel et al. do not explicitly teach: 11. The apparatus of claim 9, wherein: the one or more thiol linkers has a molecular weight from about 500 Da to about 10,000 Da; the first photoreactive monomer has a molecular weight from about 250 Da to about 50,000 Da; or a combination thereof. 24. The apparatus of claim 1, wherein the first photoreactive monomer has a molecular weight from about 200 Da to about 5,000 Da. 27. The apparatus of claim 1, wherein the first photoreactive monomer has a molecular weight from about 200 Da to about 2,000 Da.
See Oakey et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made modify the apparatus of Hohnel et al. with appropriate molecular weight of necessary solutions for hydrogel fabrication as taught by Oakey et al., since the use of necessary solutions with the claimed molecular weights are well-known in hydrogel polymerization (Oakey et al. ¶ 0012, 0108, 0158, 0164). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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, CHARLES CAPOZZI can be reached at (571)270-3638. 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.
/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
Prosecution Insights