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 .
Response to Amendment
Applicant's amendment and argument filed June 5, 2026, in response to the non-final rejection, are acknowledged and have been fully considered.
Claims 1, 3, 5, 11-13, 16, 20, 23, 25, 28-30, 37, 41, 44, 50, 54, 55, 59, and 69 are pending of which claims 28-30, 37, 41, 44, 50, 54, and 55 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pending claims 1, 3, 5, 11-13, 16, 20, 23, 25, 59, and 69 have been examined on the merits.
Response to Arguments
Applicant has argued that the arrangement of the device of Montgomery (fig 1 and cells or canals 10) and is intended to be folded in use, and thereby provides a materially arranged device different than instantly claimed. Applicant's arguments have been fully considered but they are not persuasive. In response to Applicant's argument that the references fail to show the certain features of the invention (are differently arranged), it is noted that the features upon which applicant relies (including arrangements of the preferred embodiments and figures in the specification) are not recited in the rejected claim(s). Additionally, the instant claims are recited with a degree of generality so as to remain inclusive of (do not preclude) the prior art configurations. 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). Any previous rejection or objection not mentioned herein is withdrawn.
Examiner’s Comment
In claim 3 line 6, the term “chamber” contains a typographical error and should be recited as --chambers--.
Please note the above are considered necessary grammatical corrections; however, is not exhaustive of all possible informalities in the claims and/or specification, as examination is not made for the purpose of securing grammatical perfection. (See MPEP 601.01(g)). Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al ( “Stiffness Dependent Separation of Cells in a Microfluidic Device” PLoS ONE October 2013, 8(10): e75901, pp1-10; doi:10.1371/journal.pone.0075901.)
The instant claims are drawn to a device comprising a, or a plurality of, fillable chamber(s), each having: first and second layers; an inlet and outlet, and retention members, said retention members arranged in a series of spaced veins, between the first and second layer and creating a continuous channel from the inlet to the outlet.
Wang however anticipates the claims by teaching a device as claimed, the device of Wang comprising a microfluidic cell (having top and bottom surfaces, broadly first and second layers), configured with a fluidic channel providing spacing between and defined by the inlet and outlet. The channel also has a plurality of flow-directing ridges (retention members, veins) evenly spaced between the layers and along the channel and directing flow from the inlet to the outlet (see Wang, e.g. at figs 1 A-D).
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.
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) 1, 3, 5, 11-13, 16, 20, 23, 25, and 59 stand as rejected under 35 U.S.C. 103 as being unpatentable over Montgomery et al (US 2001/0025191 A1).
The instant claims are drawn to a device comprising a, or a plurality of, fillable chamber(s), each having: first and second layers; an inlet and outlet, and retention members, said retention members arranged in a series of spaced veins, between the first and second layer and creating a continuous channel from the inlet to the outlet.
Montgomery ‘191, however, teaches a device suitable as a transplant organ external cooling system, the device comprising a fillable chamber having first and second layers; an inlet and outlet, and retention members arranged in a series of spaced veins, between the first and second layer and creating a continuous channel from the inlet to the outlet (broadly, retention members spaced between the inlet and outlet). Montgomery ‘191, although not identical in that the references does not anticipate under 35 USC 102, would have at least been obvious to have provided such an arrangement as instantly claimed including a plurality of chambers. ‘191 teaches providing a sleeve or blanket (broadly a multi-layer, flexible, resilient form (see entire document, e.g. [0009-0011], [0028]+) and which may be arranged to contain fluid in a circulating series of channels having an inlet and outlet (e.g. see figures, and as in the figures e.g. fig. 1, esp. canals/channels (10, and inlet/outlet ports 12 & 14 ), whereby the device may further comprise pumps (18), tubing (20), and temperature regulation including via cooling [0030] and heating [0031] mechanisms (see e.g. [0029]+).
Consequently, it would have been obvious to have provided a device as instantly claimed. Montgomery ‘191 is relied upon for the reasons discussed above. If not expressly taught by the reference, based upon the overall beneficial teaching provided by this reference with respect to the variety of configurations and array of tissues and organs suitable therewith, in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable shapes/elongations/positions/spacing, duplications/pluralities, materials and ranges in which to provide a device as claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim Objections
Claim 69 is objected to as depending from a rejected base claim, however, is otherwise free of the art.
Conclusion
No claims are presently allowed.
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 AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/ Primary Examiner, Art Unit 1655
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