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Claims 1-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 02/18/2026.
Applicant’s election without traverse of Group II in the reply filed on 02/18/2026 is acknowledged.
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 30 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.
The term “miniaturized” in claim 30 is a relative term which renders the claim indefinite. The term “miniaturized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear the size of the device that is classified as “miniaturized”. This could be a varying degree of sizes and the claim provides no further limitations. Further clarification is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 22-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ludlam et al. (WO2018213357A1) in view of Li et al. (CN106145187A).
Regarding Claim 22, Ludlam teaches the following:
A cell culture system comprising.. a microfluidic enabled multiwell plate (para 36)(a microfluidics system)
The microfluidic layer may itself comprise a plurality of sublayers including a well layer 302 (sampling chambers layer), a fluid routing layer 304 (payload plumbing layer), pneumatic membrane layer 306 (flexible membrane), and pneumatic layer 308 (control valves layer, where the well layer 302 may comprise the plurality of wells themselves, while fluid routing layer 304 may comprise microfluidic channels through which fluid may flow to and/or from the channels, pneumatic membrane layer 306 and pneumatic layer 308 may work together to use pneumatic force to cause the opening and/or closing of microvalves and/or the actuation of micropumps to control the flow of fluid through the microfluidic channels of layer 304 and into and/or out of the wells of layers 302 (para 77 and 78) and the layers included in microfluidics layer 300 may be stacked with well layer 302 on one side (e.g., the bottom of microfluidics layer 300), followed by fluid routing layer 304, then pneumatic membrane layer 306, then pneumatic layer 308 on the opposite side (e.g., the top of microfluidics layer 300) as well layer 302 (para 79) and the pneumatic layers discussed herein may be used in order to enable each of a large number of wells (e.g., 48 wells, 96 wells, or more) to be individually addressable (para 234)(a control valves layer, a flexible membrane beneath the control valve layer, a payload plumbing layer with configurable addressable ports beneath the flexible membrane, and a sampling chamber lay beneath the payload plumbing layer)(also see
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Fig. 3A above)
A middle tier of the device comprises a multiplexer associated with signal processing (para 385). The multiplexer being used for fluid control is an intended use of the device. 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. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The multiplexer of Ludlam would be capable of fluid control and therefore meets the claim.
Ludlam does not teach an integrated analysis chip for sample analysis.
Li, in the same field of endeavor, teaches a microfluidic chip for gene detection (Abstract). Li further teaches the cell screening, capture, identification step (analysis) is integrated on a micro-fluidic chip (integrated analysis chip)(para 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an integrated analysis chip to the device of Ludlam as taught by Li. One would have been motivated to make this modification as it greatly reduces the number of operation steps thereby improving the success rate and reliability of experiments (para 34).
Regarding Claim 23, Ludlam in view of Li teach all of the limitations of Claim 22 (see above). Ludlam further teaches one or more of the layers 304, 306, 308 may be permanently bonded to one another, such as pressed, and/or heated and melted together (para 80). This would require the layers to be independently prepared and the joined together with the flexible membrane.
Regarding Claim 24, Ludlam in view of Li teach all of the limitations of Claim 23 (see above). The limitations of Claim 24 are product-by-process. The patentability of a product is independent of how it was made. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
Regarding Claim 25, Ludlam in view of Li teach all of the limitations of Claim 22 (see above). Ludlam further teaches one or more of the layers 304, 306, 308 may be permanently bonded to one another, such as pressed, and/or heated and melted together and layer 302 may be bonded by adhesives (para 80)(the control valves layer, the payload plumbing layer, the sampling chambers layer, and the flexible membrane are joined together by a bonding method selected from a group consisting of chemical bonding, thermal bonding, pressure bonding, and combinations thereof).
Regarding Claim 26, Ludlam in view of Li teach all of the limitations of Claim 22 (see above). The limitations of Claim 26 are product-by-process. The patentability of a product is independent of how it was made. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on applicants to show product differences in product by process claims.
Regarding Claim 27, Ludlam in view of Li teach all of the limitations of Claim 22 (see above). Ludlam further teaches a computer 1300 as a component of the microfluidics system as system 100 and any of its subcomponents. Computer 1300 is configured to execute live cell culture, assay and is configured to control, monitor, or otherwise send and/or receive electronic signals to and/or from any one or more of the devices described (para 248)(data processing unit configured to analyze data obtained from collected samples and a communication means for transmitting data to the data processing unit).
Regarding Claims 28 and 29, Ludlam in view of Li teach all of the limitations of Claim 22 (see above). Ludlam further teaches the system is a tabletop system configured to manipulate and monitor live cells for.. assays (para 36)(a plurality of chemical assays). The chemical assays for analyzing samples gather in vivo and for analyzing cranial bone defect-relayed properties is an intended use of the device. 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. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The assays of Ludlam would be capable of being used in the claimed manner and therefore meet the claim.
Regarding Claim 30, Ludlam in vies of Li teach all of the limitations of Claim 22 (see above). Ludlam further teaches the multiwell plate device may have a footprint that enables the device to be inserted into docking stations or other laboratory or field equipment (para 54)(the layers are integrated into a single portable system).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799