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
Applicant’s election without traverse of group I (claims 1-13, 15-17, and 19), in the reply filed on October 3, 2025 is acknowledged. Claims 1-13,15-17,19-22 and 24-25 are pending of which claims 20-22 and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Pending claims 1-13,15-17, and 19 have been examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 2 (at line 2), the claim recites the limitations "the vasculature” and “the extracellular space”. There is insufficient antecedent basis for the limitations in the claim(s). Clarification is required.
In claim 6 the claim is unclear, because (at line 3) it is unclear if the “scaffold”, “gel” and “wafer” are each intended as a material form (as are the normal usage of the terms in the art), a biological material per se, or if another interpretation is intended. Clarification is required.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-13,15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) or (a)(2)) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Martin et al (WO 2020/013851 A1; cited as Corning Inc, on IDS).
The instant claims are drawn to a process comprising perfusing a biological sample in a sealed, channeled device with a flow of liquid through the channel (see instant claims 1+).
Martin ‘851, however, although not identical, teaches a microfluidic device (100) comprising channels (106) having a microplate (102) and lid ((120), sealed, channeled device as required of instant claims 1+; see ‘851 e.g. at fig 1 and [0001, 0005]) permissive of flow among/between sample wells (broadly, passing through extracellular space as required of instant claim 2), and suitable for a variety of biological samples including cells and organoids ([0005], see instant claims 6). The arrangement is considered to also provide for insertion of the sample via an inlet reservoir (as required of claim 11) Although the reference does not expressly recite the cell types, the device is taught as capable of being configured to partially store and/or maintain “any liquid medium or cells” ([0038]; see instant claims 7-9). The device is further taught as being “sized and shaped to simultaneously permit the fluid to flow through the plurality of channels 106 at a sufficient rate to thereby facilitate formation of the necessary shear stress” ([0050]; broadly, dimensions (suitable for transport of solute with a Peclet no. of 1 or more, a resistance of 0.3mmHg ml-1 min-1, a time of about 30 minutes (as required of claims 3-5) and as required of claims 10-13, and 15). Regarding claims 16, 17, and 19, the claims are recited with a breadth so as to broadly and reasonably remain inclusive of reading upon the cells and cell growth (and observations by one practicing the methods thereof with routine manually activities and monitoring/sampling the cells and health thereof (growth/starvation/apoptosis therein)).
The cited reference discloses a device and operation/use thereof comprising fluidically treating a biological sample, which appears to be identical to that presently claimed, since it provides perfusion and fluidic flow with a biological sample sealed therein and arranged with microfluidic dimensions and lid-sealing as instantly claimed, including obtaining a result as claimed, including perfusion of an organoid therewith. Consequently, the claimed device and process therewith appears to be anticipated by the reference.
In the alternative, even if the device and use thereof (with respect to a fluidic flow rate, or preferred dimension and tissue selection) is not identical to the referenced composition, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of the claimed composition, particularly in view of the similar characteristics which they have been shown to share (e.g. lid-sealed microfluidic device, having a perfusion flow rate, and in light of the broad teachings of providing any tissue, fluid, device dimensions suitable therefor). Thus, the claimed process and devices therein would have been at least obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are presently 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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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