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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/02/2026 has been entered.
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 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) 13, 14, 21 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kamm et al. (US 2014/0057311 A1).
Regarding claim 13, Kamm et al. teach:
13. A fluidic device comprising:
a multilayer fluidic structure (see annotated Fig. 16A for example) having formed therein:
a fluidic channel (e.g., media channels);
a hydrogel chamber residing vertically above said fluidic channel, said hydrogel chamber being defined at least in part by a side wall and a base surface that separates the hydrogel chamber from the underlying fluidic channel, said base surface having an aperture defined therein such that said hydrogel chamber is in direct fluid communication with said fluidic channel through said aperture (see annotated Fig. 16A for example);
a media reservoir residing vertically above said hydrogel chamber, said media reservoir being in fluid communication with said hydrogel chamber (see annotated Fig. 16A for example); and
a ridge projecting from said base surface and positioned adjacent to said aperture (see annotated Fig. 16A for example).
Annotated Fig. 16A of Kamm et al. (US 2014/0057311 A1)
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With regard to limitations in claim 13 (e.g., [...] when a hydrogel precursor solution is delivered to said hydrogel chamber for in-situ formation of a hydrogel therein and substantially fills the hydrogel chamber, the ridge resists vertical flow of the hydrogel precursor solution upwardly out of said hydrogel chamber, thereby preventing contact of the hydrogel precursor solution with one or more surfaces of said media reservoir), 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.
It is noted that recited elements such as a hydrogel precursor solution, the in-situ formation of a hydrogel, or the hydrogel contained in the hydrogel chamber are not positive elements of the claim. In addition, the recited feature relating to hydrodynamic resistance is a variable that depends on the physical properties of the device, such as the dimensions and surface chemistry of the ridge, hydrogel chamber, and fluidic channel. It also depends on the viscosity of the hydrogel, as well as the physical force applied to the device and its resulting effects.
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)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding claims 14, 21, Kamm et al. teach:
14. The fluidic device according to claim 13, wherein said aperture is a first aperture and said base surface is a first base surface, and wherein said media reservoir is defined in part by a second base surface having a second aperture defined therein such that said media reservoir is in fluid communication with said hydrogel chamber through said second aperture, and wherein said ridge resides on a portion of said second base surface that lies adjacent to said second aperture (see annotated Fig. 16A for example).
21. The fluidic device according to claim 13, wherein the hydrogel chamber has a height-to-width aspect ratio of less than one (see i.e., 120 μm height and 1200 μm width in Fig. 1).
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive.
The amendments have been considered and 35 USC § 112 rejections have been withdrawn.
In response to the Applicant's arguments to amended claim 13 reciting a hydrogel chamber residing vertically above said fluidic channel; and a media reservoir residing vertically above said hydrogel chamber, the Examiner addressed the arguments within the above art rejection.
In response to the Applicant's arguments to the process or intended use limitations, the Examiner notes that recited elements such as a hydrogel precursor solution, the in-situ formation of a hydrogel, or the hydrogel contained in the hydrogel chamber are not positive elements of the claim. In addition, the recited feature relating to hydrodynamic resistance is a variable that depends on the physical properties of the device, such as the dimensions and surface chemistry of the ridge, hydrogel chamber, and fluidic channel. It also depends on the viscosity of the hydrogel, as well as the physical force applied to the device and its resulting effects.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The Courts have held that limitations regarding the contents, intended use or manner of operating an apparatus do not further limit the patentability of apparatus claims. 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)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is encouraged to amend the claims to include additional structural elements of the device.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1795
DEAN KWAK
Primary Examiner
Art Unit 1795
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