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 .
Election/Restrictions
Claims 1-31 are pending. Claims 18-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June m24, 2025. Pending claims 1-17 have been examined on the merits.
Claim Rejections - 35 USC § 102
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(s) 1 and 5-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffith et al (US 2018/0272346 A1).
The instant claims are drawn to a device (“microfluidic platform”) comprising: a chamber, a gel-filled channel, and a plurality of contiguous zones having an additional zone between at least at least two of the zones, and reservoirs or pump connected to openings in the chamber.
Griffith ‘346 however teaches (see e.g. fig 48 and para. [0227+]) a device comprising a chambered platform comprising microfluidic components having a gel-fillable channel (4006) positioned between and comprising a plurality of zones (4001, 4003), a reservoir (4015), and peristaltic pumps (4014), in fluid connection (tubing 4016 and ports connecting therewith to provide). Griffith also teaches that the complexity and sophistication of the platform may be provided with (see [0353-0354]) “primary cells, cell lines, pluripotent stem cells, progenitor cells, organoids, or any combination of mammalian or non-mammalian cells”, “an extracellular matrix gel” (see instant claims 11,12), seeded or covered with endothelial cells (see instant claim 13), or stroma (see instant claim 14), or “triple negative breast cancer (TNBC)…micrometastases in liver…MDA-MB-231” (see instant claim 14, tumor cells). In some embodiments Griffith teaches that the platform may be also used with “ islets or lymph nodes form 3D vessels that allow perfusion” ([0353]; broadly, vascularized tissue/masses, allowing perfusion; see instant claims 15-16)). The sample is further provided to the device or in a transwell “insert”, “added to the central circulation unit” or “added to the central circulation . unit or any of the individual [microphysiological systems] MPS circulation units” [0353]. Griffith also teaches the sample insertion into and removal from the device via a removable insert [0184-0192] (broadly, a configuration suitable for cell introduction by top- or gel-insertion, see instant claim 10).
Claim Rejections - 35 USC § 103
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) 1-11 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kamm, et al (US 9,261,496 B2).
The instant claims are as of record, drawn to a microfluidic platform device comprising a chamber, gel-filled channel, plurality of contiguous zones having an additional zone between at least at least two of the zones, and reservoirs or pump connected to openings in the chamber.
It would have been at obvious at the instant invention effective filing to have provided a device as instantly claimed, as taught by Kamm. The reference teaches devices, which although not identical (not anticipating under 35 USC 102, however teaches providing a device comprising: “(i) a first fluid channel; (ii) a second fluid channel; (iii) one or more fluid inlets; (iv) one or more fluid outlets; (v) a gel cage region which forms a gel channel; (vi) a gel channel inlet; and (vii) a plurality of posts. In this device all or a portion of one side of the gel channel is flanked by, and parallel to, all or a portion of the first fluid channel thereby creating a first gel channel-fluid channel interface region; and all or a portion of the other side of the gel channel is flanked by, and parallel to, all or a portion of the second fluid channel thereby creating a second gel channel-fluid channel interface region. The gel channel comprises two parallel rows of posts, in which each row of posts is along the length of the gel channel and one row is along one side of the gel channel at the first gel channel-fluid channel interface, and the other row is along the other side of the gel channel at the second gel channel-fluid channel interface, thereby forming a gel cage region along the length of the gel channel; and each post forms a triangle, a trapezoid or a combination thereof” (‘496, at col 2; see instant claim 1). The device may be provided with a plurality of zones (see figures, e.g. 19A), including a plurality of cages (gel cages 1-3) each cage bookended by two inlets (also gel cage 2 between gel cages 1 and 3) (see instant claim 1, a tissue zones between at least two other zones). Kamm further teaches that “the height and width of a gel cage (e.g., channel), and the length of a gel cage region determine the probability of successfully filling the gel cage region, and therefore manufacturing the device” and that “wider gel channels are easier to fill, and narrower channels have higher resistance, and therefore require more pressure to fill. Fluidic resistance depends on both the width and the length of a channel. As long as the pressure necessary to fill a device is less than the surface tension of an inter-post gel-media interface, the gel will continue to fill and not spill. As the filled gel region becomes longer, the required pressure to fill increases, and will eventually match the surface tension of a inter-post region, causing a spill. This means that in order to fill a long channel, either the gel channel must be wider (to reduce resistance), or the post spacing shorter (to increase surface tension). There is interplay between post spacing, channel width, and the maximum fillable channel length.” (‘496 at “Width of Gel Channel”); and may include (see at “Regions, Channels, Chambers”) pumps including “media pumped into one or more media ports” and (see at “Cell and Device Preparation”) connected external reservoirs. The device may further comprise matrix metalloproteinases inhibition (MMPs, broadly MMP-2, inhibitor; see at example 4; see instant claim 17) and lung cancer cells and HUVEC cultured into vascular networks (see ’496 at example 4; instant claim 14-17).
Kamm ‘496 is relied upon for the reasons discussed above. If not expressly taught by the reference, based upon the overall beneficial teaching provided by thereby with respect to the cells, arrangements of the device, and dimensions (length, width, and dimensions or proportions thereof) therewith in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable arrangement and shape ranges in which to provide a tissue microfluidic platform suitable therefor), 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.
Conclusion
No claims are allowed.
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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/AARON J KOSAR/Primary Examiner, Art Unit 1655