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 .
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) 57, 59-66 and 68-75 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Craighead et al. (US 2018/0305682).
Regarding claim 57, Craighead et al. teach:
57. A device (e.g., 10) for isolating a fraction of a biological sample (¶ 0008+), comprising:
one or more restriction channels (e.g., 32) having an inlet end (e.g., beginning end of 32) and an outlet end (e.g., terminal end of 32), wherein the inlet end and the outlet end of the one or more restriction channels are in fluid communication through the one or more restriction channels (see ¶ 0055 & Fig. 1 for example);
a plurality of spaced-apart obstructions (e.g., micropillars 41) lodged in the one or more restriction channels (see Fig. 1 for example) capable of providing resistance to flow (see i.e., micropillar arrays 40 and micropillars 41 produce a hydrodynamic force ¶ 0059), wherein the spacing between obstructions decreases in the direction from the inlet end of the one or more restriction channels to the outlet end of the one or more restriction channels (see Fig. 1 for example);
an inlet reservoir (e.g., inlet port 22; see also “INPUT” in Figs. 1-2 for example) capable of holding a fluid (see i.e., inlet port 22 for receiving a sample containing at least one cell ¶ 0054), wherein the inlet reservoir is in fluid communication with the inlet end of the one or more restriction channels (see Fig. 1 for example); and
one or more uniform flow channels (e.g., inflow channel 44) having an inlet end (i.e., upstream end of the inflow channel 44) and an outlet end (i.e., downstream end of the inflow channel 44), wherein the one or more uniform flow channels (44) are discrete from and parallel to the one or more restriction channels (32) (see Fig. 1 showing the element 44 is discrete and laterally parallel to the element 32), wherein the inlet end and the outlet end of the one or more uniform flow channels are in fluid communication through the one or more uniform flow channels, wherein the inlet end of the one or more uniform flow channels is in fluid communication with the inlet reservoir (see Fig. 1 for example).
Regarding claim 1, Craighead et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “for isolating a fraction of a biological sample”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claims 57, 58, 62, 69-73 (e.g., [...] for providing resistance to flow, [...] for holding a fluid; [...] to flow from 1-90% of flow in the device within the one or more uniform flow channels, 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)). "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). Further, reciting “configured to” without identifying any structural differences between the structure in the claims and the structure disclosed by the prior art does not further limit the claims.
Regarding claims 59-61, 63-66, 68-75, Craighead et al. teach:
59. The device of claim 57, further comprising an outlet reservoir (e.g., outlet port 24; see also “OUTPUT” in Figs. 1-2 for example) in fluid communication with the outlet ends of the one or more restriction channels and the one or more uniform flow channels (see Figs. 1-2 for example).
60. The device of claim 57, wherein the one or more restriction channels comprise a barrier band having fenestrations of at least about 1 micrometers (¶ 0109).
61. The device of claim 57, wherein the one or more restriction channels comprise fenestrations of about 4-200 micrometers (¶ 0109).
63. The device of claim 57, further comprising a substrate, wherein the one or more restriction channels and the one or more uniform flow channels are integral with the substrate (¶ 0109).
64. The device of claim 57, wherein the one or more restriction channels are microfluidic channels (Abstract+).
65. The device of claim 57, comprising means for analyzing a biological sample in the one or more restriction channels, means for measuring the level of an isolated fraction of the biological sample within the one or more restriction channels (¶ 0077, 0104, 0124).
66. The device of claim 57, wherein the plurality of obstructions comprise pillars integral with the one or more restriction channels (see ¶ 0055 & Fig. 1 for example).
68. The device of claim 57, wherein the plurality of obstructions comprise polymer particles (¶ 0089).
69. The device of claim 57, wherein the device is configured to isolate a fraction of a biological sample comprising a human bodily fluid (¶ 0048).
70. The device of claim 57, wherein the device is capable of isolating a fraction of a biological sample comprising a carrier fluid (¶ 0104, 0111).
71. The device of claim 57, wherein the device is capable of isolating a fraction of a biological sample comprising one or more reagents (¶ 0016, 0104, 0111, 0116+).
72. The device of claim 57, wherein the one or more restriction channels further comprise binding moieties for binding a biomarker (¶ 0116).
73. The device of claim 57, wherein the device is capable of isolating a fraction of a biological sample from a subject undergoing a diagnosis (¶ 0116).
74. The device of claim 57, further comprising a serpentine fluid mixing region in the one or more restriction channels (this limitation is sufficiently broad to have read on a region formed by the micropillars).
75. The device of claim 57, wherein the one or more restriction channels or the one or more uniform flow channels have a fluorinated coating (see i.e., micropillars immobilized (coated) with fluorescent dyed DNA fragments ¶ 0035, 0102+ & Fig. 4 for example).
Claim Rejections - 35 USC § 103
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) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Craighead et al. (US 2018/0305682) in view of Holmes et al. (US 2018/0231533).
Regarding claim 58, Craighead et al. teach: 58. The device of claim 57, further comprising a pressure source (e.g., syringe pump ¶ 0084) capable of applying pressure to the fluid in the inlet reservoir. However, Craighead et al. do not explicitly teach: a flow sensor in fluid communication with the inlet reservoir.
Holmes et al. teach: a device comprising a pressure source (e.g., pumps ¶ 0188+) capable of applying pressure to a fluid in an inlet reservoir (¶ 0188+); and a flow sensor in fluid communication with the inlet reservoir (¶ 0157, 0286+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Craighead et al. with a flow sensor of Holmes et al. to detect a change in operation parameters (Holmes et al. ¶ 0157, 0286+).
Claim(s) 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Craighead et al. (US 2018/0305682) in view of Russell et al. (US 2013/0184318).
Regarding claim 67, Craighead et al. do not explicitly teach: 67. The device of claim 57, wherein the plurality of obstructions comprise a portion of a human juxtacanalicular meshwork.
Russell et al. teach: a portion of a human juxtacanalicular meshwork (¶ 0012, 0150-0155+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the plurality of obstructions of Craighead et al. with a portion of a human juxtacanalicular meshwork, as taught by Russell et al. to improve the compliance of meshwork tissue for treating diagnosed conditions (Russell et al. ¶ 0150-0155).
Response to Arguments
Applicant's arguments filed 12/11/2025 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 argument that Craighead et al. do not teach: one or more uniform flow channels are discrete from and parallel to one or more restriction channels, Examiner disagrees. Craighead et al. teach, among other things, wherein the one or more uniform flow channels are discrete from and parallel to the one or more restriction channels (see Fig. 1 showing the element 44 is discrete and laterally parallel to the element 32).
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
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 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.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798