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Claims 14-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/07/2026.
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on 01/07/2026 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.
Claims 7-9 are 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.
Claim 7 recites the limitation "the incubator" in lines 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same incubator as the portable incubator of Claim 5 or a different incubator entirely. Further clarification and correction is required. For examination purposes, it is interpreted as the incubator from Claim 5.
Claim 7 recites the limitation “the cassette system is disposed within the incubator”. It is unclear how the cassette system can comprise the incubator (form claim 5) and also be disposed within the incubator. This would require the incubator being disposed within itself. Further clarification and correction is required.
Claim 8 recites the limitation "each of the one or more channels" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner believes this is referring to the one or more incubating channels and for examination purposes is interpreted as such. Further clarification and correction is required.
Claim 9 is further rejected as it depends from Claim 8.
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.
Claims 1-3, 8, 10, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toombs et al. (WO2022058749A1).
Regarding Claim 1, Toombs teaches the following:
A microfluidic cassette 100 which performs diagnostic processing on a liquid biological sample (page 8, lines 5-7) which is inserted in a host device which includes heating/cooling components (page 8, lines 16-19)(a portable, closed cell incubating cassette system)
The cassette includes a microfluidic channel 101 (incubating channel) which is an enclosed fluid flow channel that is arranged to allow a biological liquid sample to flow through (an inlet configured to receive a volume of a liquid sample which is fluidically connected to one or more incubating channels)
The device includes first and second valves 105 106 (each of the one or more incubating channels comprising one or more gates located in the one or more incubating channels) (page 10, line 7 and Fig. 1, below)
PNG
media_image1.png
531
707
media_image1.png
Greyscale
The first valve 105 is located adjacent to the first port 103 to selectively control the flow of fluid between the deformable chamber and the fluid reservoir (via the first port 103). The second valve 106 is located adjacent to the second port 104 to selectively control the flow of fluid between the deformable chamber and the microfluidic channel 101 (via the second port 104)(page 10, lines 10-14)(each of the one or more gates having an open position and a closed position, wherein each of the one or more gates when in the open position is configured to permit the sample to fluidly connect to a remaining portion of each of the one or more incubating channels, and wherein each of the one or more gates when in the closed position is configured to block the sample from fluidly connecting to the remaining portion of each of the one or more incubating channels)
One or more sample incubation chambers each disposed in each of the one or more incubating channels between the inlet and each of the one or more the gates (Fig. 1, above)
PNG
media_image2.png
708
863
media_image2.png
Greyscale
Regarding Claim 2, Toombs teaches all of the limitations of Claim 1 (see above). Toombs further teaches a sample processing region 210 (one or more sample storage chambers) which is fluidly connected to each of the one or more sample incubation chambers via each of the one or more gates (see Fig. 2, below) and sample processing region 210 can include one or more filters (page 13, lines 23-26)(comprises an absorbent material).
The sample processing region has a fixed volume and therefore is configured to collect the liquid sample in a fixed, known volume.
Regarding Claim 3, Toombs teaches all of the limitations of Claim 2 (see above). Toombs further teaches a fluid storage chamber 207 (page 13, lines 19-21 and Fig. 2, above)(one or more excess sample chambers fluidly connected to each of the one or more sample storage chambers)
Regarding Claim 8, Toombs teaches all of the limitations of Claim 1 (see above). Toombs further teaches the processing of a sample is carried out by allowing the sample to interact with reagents in the channels or chambers of the device (page 8, lines 24-26)(each of the one or more incubating channels is preloaded with at least one reagent).
Regarding Claim 10, Toombs teaches all of the limitations of Claim 1 (see above). Toombs further teaches positive pressure is generated in the microfluidic channel 101 to cause fluid to move along the channel 101 (page 9, lines 23-24)(the liquid sample moves through the cassette system by at least one of capillary action, positive pressure, or negative pressure).
Regarding Claim 12, Toombs teaches all of the limitations of Claim 1 (see above). Toombs further teaches the cassette can be used to perform on-cassette diagnostic processing on a liquid biological sample such as a blood (page 8, lines 6-7).
Regarding Claim 13, Toombs teaches all of the limitations of Claim 1 (see above). Toombs further teaches the microfluidic cassette is used to perform biochemical analyses (detection of a particular biomarker) on a fluid sample provided by a patient at a point of care (page 1, lines 8-10).
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Toombs et al. (WO2022058749A1) in view of Morikoshi (US20220118439A1).
Toombs teaches all of the limitations of Claim 1 (see above). Toombs does not teach a desiccant having gaseous connection to each of the one or more sample storage chambers and each of the one or more excess sample chambers, wherein the desiccant is configured to absorb moisture from at least one of each of the one or more sample storage chambers or each of the one or more excess sample chambers.
Morikoshi teaches a cartridge for detecting characteristics of a fluid in a diagnostic assay system with a plurality of chambers (Abstract). Morikoshi further teaches a hygroscopic element which is a partition wall containing a desiccant, dehumidifying material, a silica gel, etc. (para 76).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Toombs with the desiccant as taught by Morikoshi. One would have been motivated to make this modification as it would extend an active period of interacting a fluid with a reagent (para 76). Further the desiccant located within the device would mean it has a gaseous connection to each of the one or more sample storage chambers and each of the one or more excess sample chambers and configured to absorb moisture from at least one of each of the one or more sample storage chambers or each of the one or more excess sample chambers.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Toombs et al. (WO2022058749A1) in view of Vukasinovic et al. (US20100151571A1).
Regarding Claim 5, Toombs teaches all of the limitations of Claim 1 (see above). Toombs further teaches the cassette is arranged to be inserted into a host device. Toombs does not teach a portable incubator configured to warm the cassette to a constant and controlled temperature for a duration of time.
Vukasinovic teaches portable diagnostic incubators for use in biological culturing (Abstract). Vukasinovic further teaches the incubator 10 houses a biocompatible polydimethylsiloxane, for example, perfusion chamber 30 with a centrally placed cell culture life support perfusion chamber 20 (microfluidic device), a semi-permeable membrane aerator 21 that encapsulates the chamber 20, a miniature, thin flexible heater 16 that maintains a desired temperature within the incubator 10 or heated enclosure 11 (para 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Toombs and have it inserted into or surrounded it by the incubator as taught by Vukasinovic. One would have been motivated to make this modification as it would allow the control and the ability to maintain a desired temperature (para 31).
Regarding Claim 6, Toombs in view of Vukasinovic teaches all of the limitations of Claim 5 (see above). Vukasinovic further teaches a DC power supply that can be replaced with a battery for portability (para 40).
Regarding Claim 7, Toombs in view of Vukasinovic teaches all of the limitations of Claim 5 (see above). Vukasinovic further teaches the modular infrastructure can support a number of mini-incubators 10 with their separate perfusion chambers 30 that can be easily plugged in and out of a centralized system (the cassette is disposed within the incubator as a separate component). (para 89).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Toombs et al. (WO2022058749A1) in view of Semmel et al. (WO2022074657A1).
Toombs teaches all of the limitations of Claim 8 (see above). Toombs does not explicitly teach the at least one reagent includes at least one of an antibody, a ligand, an antigen, or a growth medium.
Semmel teaches a cartridge for determining a biological condition (Abstract). Semmel further teaches the presence of a pre-packed dry reagent in a channel/ chamber within the cartridge. Once the liquid sample is introduced to the cartridge and is brought into contact with the dry reagent, the dry reagent is dissolved or dispersed into the liquid sample. If for example the dry reagent comprises an antibody, and the sample is a blood sample, the antibody dissolves into the blood sample and binds to a corresponding cell in the sample (para 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Toombs and pre load the channel with a reagent such as an antibody as taught by Semmel. One would have been motivated to make this selection as it would bind to the corresponding cell in the sample (allowing the detection of the cell)(para 12).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Toombs et al. (WO2022058749A1) in view of Wilkinson et al. (WO2009055603A2).
Toombs teaches all of the limitations of Claim 1 (see above). Toombs does not teach the cassette system comprises a door configured to hingedly open to provide access to the cassette system.
Wilkinson teaches a container for storing a biological sample (Abstract). Wilkinson further teaches housing 23 of sample holder 11 is a closable structure, and may include a hinged door-like structure 20 attached with housing 23 (para 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Toombs with the hinged door-like structure as taught by Wilkinson. One would have been motivated to make this modification as it would permit access to the internal cavity 24 for storing a tissue sample within or removing a tissue sample from internal cavity (para 68).
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.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
Prosecution Insights