Prosecution Insights
Last updated: April 19, 2026
Application No. 18/383,620

DISPOSABLE CARTRIDGE FOR PERFORMING AN AUTOMATIC SAMPLE PREPARATION

Non-Final OA §103§112
Filed
Oct 25, 2023
Examiner
GZYBOWSKI, MICHAEL STANLEY
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Pratimesh Labs Pvt Ltd.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
96 granted / 139 resolved
+4.1% vs TC avg
Strong +53% interview lift
Without
With
+52.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
90 currently pending
Career history
229
Total Applications
across all art units

Statute-Specific Performance

§101
2.8%
-37.2% vs TC avg
§103
51.0%
+11.0% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
27.1%
-12.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 139 resolved cases

Office Action

§103 §112
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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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 appl icant regards as his invention. Claims 1-17 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 1 recites that the barrel housing is “configured to host” extruded barrels for housing liquids in line 3 . This recitation of the barrel housing be “configured” or able to host barrels fails to actually recite that barrels are present. As such recitations of the barrels and frangible seals subsequent to reciting that the barrel housing is “configured” to host barrels lack antecedent basis in the claims. Similarly, line 7 of claim 1 recite that the puncturing layer is “configured to host needle” which fails to positively recite needled as elements of the disposable cartridge. Claim Rejections - 35 USC § 103 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. 1. Claim s 1, 5-8 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017 / 0197213 to Nielsen et al. (cited by applicant) in view of International Patent Application Publication No. WO2017041023 to Lafferty et al. (cited by applicant) Nielsen et al. teaches a disposable cartridge for performing automatic sample preparation that includes a layer having containers (interpreted as “barrels”) that are sealed with a frangible seal at the bottoms of the containers as shown in Fig. 8 . The containers are plunger (“piston”) actuated. ([0178]; Fig. 55) Nielsen et al. teaches puncturing elements (interpreted as being “needle s ”) that puncture the frangible seals of the barrels. ([0089]; Fig. 9). Nielsen et al. further teaches fluidic channels (e.g., microfluidic channels) for routing fluids to different functional compartments within the cartridge , in addition to valves and ports, and a reaction chamber [0011] , rendering it obvious to distribute metered amounts of fluid provided in the barrels into different and multiple fluid channels to conduct desired analysis on samples to be analyzed . Nielsen et al. further teaches that the container s can be attached to the microfluidic device with the aid of a layer of deformable material or an adhesive material (e.g., a material that is adhesive on both sides ). [0096] Lafferty et al. teaches a cartridge that includes elastomeric membranes and valves and teaches that the membranes form mixing chambers. ([00165}; Figs. 26A -26C). In addition, Lafferty et al. teaches that any suitable known actuator can be used to create valves along the elastomeric membrane(s) and the fluid flow path. In discussions of embodiments having one or more elastomeric membrane(s) that act to define a fluid flow path, any disclosed valving can be accomplished using the toggle clamps of FIG. 38 , plungers, or other known actuation elements. [00139] , [00118] Lafferty et al. further teaches that actuators can be can be disposed along the channel to permit and restrict fluid from flowing along the fluid flow path , thus functioning as valves. [00139] The elastomeric membranes of Lafferty et al. read on applicant’s soft membrane. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. to include the elastomeric membrane of Lafferty et al. for purposes of mixing and/or valve control , and actuators (in an actuation layer) for operating the valve controlling. I.) Regarding applicant’s claim 1, as noted above Nielsen et al. in view of Lafferty et al. renders all the elements of claim 1 obvious. Therefore Nielsen et al. in view of Lafferty et al. renders claim 1 obvious. II.) Regarding applicant’s claim 5, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 5 depends. Claim 5 recites at least a top layer for covering said barrels from the side. Nielsen et al. teaches that the tops of the barrels are covered by a sealing member. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 5 obvious. III.) Regarding applicant’s claim 6, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 6 depends. Claim 5 recites at least a bottom layer for encasing said layers to protect it from human- intervention. Nielsen et al. teaches that the bottoms of the barrels are covered by a sealing member. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 6 obvious. IV.) Regarding applicant’s claim 7, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 7 depends. Claim 7 recites at least a first pressure-sensitive adhesive layer configured to join said barrel housing layer to said puncturing layer. As noted above, Nielsen et al. teaches that the containers can be attached to the microfluidic device with the aid of a layer of deformable material or an adhesive material (e.g., a material that is adhesive on both sides. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. to use a pressure-sensitive adhesive layer to attach any of the layer elements together, including the sealing layer that Nielsen et al. punctures. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 7 obvious. V.) Regarding applicant’s claim 8, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 8 depends. Claim 8 recites at least a second pressure-sensitive adhesive layer configured to join said soft membrane to said actuation layer. As noted above, Nielsen et al. teaches that the containers can be attached to the microfluidic device with the aid of a layer of deformable material or an adhesive material (e.g., a material that is adhesive on both sides. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. to use a pressure-sensitive adhesive layer to attach any of the layer elements together, including soft membrane layer and the actuating layer that causes the soft membrane to close the valves or the actuating layer that punctures the seal on the barrels. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 8 obvious. VI.) Regarding applicant’s claim 10, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 10 depends. Claim 10 recites at least a permanent valve (30,31,32,33) built inside said cartridge which can sustain more than 100kPa of pressure required for opening a valve for metering of samples with reagents. Nielsen et al. and Lafferty et al. each teach valves. In Nielsen et al. in view of Lafferty et al. it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to provide any of the valves as a valve that can sustain any pressure desired, including 100kPa of pressure. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 10 obvious. VII.) Regarding applicant’s claim 11, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 11 depends. Claim 11 recites that barrel housing layer comprising piston-operated barrels, in that, linear actuators are configured to actuate corresponding pistons for corresponding barrels in order to enable flushing out of fluid (samples) at constant volumetric flow rate. As noted above, Nielsen et al. teaches that the barrels are plunger (“piston”) actuated. ([0178]; Fig. 55) Therefore, Nielsen et al. in view of Lafferty et al. renders claim 11 obvious. VIII.) Regarding applicant’s claim 12, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 12 depends. Claim 12 recites that the barrel housing layer compris es a plurality of mixing barrels (2) for facilitating mixing of a sample as and when required, characterized in that, said mixing barrels (2) having a side vent in order to vent out air. Nielson et al teaches reagent vessel s or chamber s for effect ing fluid mixing . [0109]. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify the reagent vessels or chambers to include air vents in the reagent vessels or chambers as necessary for purposes of venting air to provide for liquid flow. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 12 obvious. IX.) Regarding applicant’s claim 13, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 13 depends. Claim 13 recites that barrel housing layer comprising at least a waste collection barrel (3) to collect waste generated after conducting a required test. Nielsen et al. teaches a waste chamber. [0110] Therefore, Nielsen et al. in view of Lafferty et al. renders claim 13 obvious. X.) Regarding applicant’s claim 1 4 , as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 1 4 depends. Claim 14 recites that the barrel housing layer comprising at least a suction chamber (5) to collect and send blood sample straight into a microfluidic channel of said liquid flow channel layer (L5). Nielsen et al. in view of Lafferty et al. does not teach a suction chamber. Nielsen et al. teaches pumps for providing pressure for fluid flow and the use of positive or negative pressure for moving fluids. [0011], [0012] It would have been obvious to one of ordinary skill before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al to include a suction chamber in which to provide a negative pressure to cause fluid to flow. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 14 obvious. XI.) Regarding applicant’s claim 1 5 , as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 1 5 depends. Claim 15 recites that the barrel housing layer comprising at least mixing barrels and pre-loaded reagent barrels, characterized in that, the center of said mixing barrels and said preloaded reagent barrels being arranged on vertices of a regular n-sided polygon to give rotation symmetry of more than four. As noted above, Nielsen et al. teaches containers for mixing. In addition, Nielsen et al. teaches reagent containers [0098]. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. to arrange the mixing and reagent vessels in any desired manner including on vertices of a regular n-sided polygon to give rotation symmetry of more than four as a matter of design choice. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 15 obvious. XI I .) Regarding applicant’s claim 1 6 , as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 1 6 depends. Claim 16 recites that the barrel housing layer comprising at least mixing barrels and pre-loaded reagent barrels, characterized in that, the center of said mixing barrels and said preloaded reagent barrels being kept on vertices of a regular pentagon and a hexagon to give 5 degree of rotational symmetry for WBCs sample preparation and 6 degree of rotational symmetry for RBCs sample preparation in order to push and mix the reagents and samples multiple times only with a two stepper motor and two linear actuators. As noted above, Nielsen et al. teaches containers for mixing and reagent containers. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. to arrange the mixing and reagent vessels in any desired manner including providing the center of the mixing barrels and the preloaded reagent barrels being kept on vertices of a regular pentagon and a hexagon to give 5 degree of rotational symmetry as a matter of design choice. Note, the intended use recited in claim 16 regarding WBCs and RBCs are process limitations that do not impart any structural limitations into claim 16 and are not afforded patentable weight. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 16 obvious. XI II .) Regarding applicant’s claim 1 7 , as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 1 7 depends. Claim 17 recites that barrel housing layer (L2) compris es a blood inlet port (4) which is connected to a suction chamber (5) by a straight microfluidic channel and several microfluidic side channels, characterized in that, said barrel housing layer (L2) compris es a membrane located above said blood inlet port (4) for creating a negative pressure inside said channel. As noted above, Nielsen et al. teaches pumps for providing pressure for fluid flow and the use of positive or negative pressure for moving fluids , rendering a suction chamber obvious. [0011], [0012] Further as noted above, Lafferty et al. teaches that the elastomeric membrane can control valves, and that deforming chambers can provide pumping (suction/pressure) . It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. to provide any desired fluid channel configuration and a suction chamber as noted above and an inlet portion for receiving a sample and a deformable membrane to function as a diaphragm pump to move fluid in the channel(s). Therefore, Nielsen et al in view of Lafferty et al. renders claim 17 obvious. XI V .) Regarding applicant’s claim 1 8 , as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 1 8 depends. Claim 18 recites that cartridge comprising vias (21, 22, 23, 24, 25, 26) made below said soft membrane in order to store blood samples so that sample volume can be increased. Applicant’s “vias” are interpreted as being channel sections. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. with any number of channel sections as a matter of design choice for any giving analysis process. Therefore, Nielsen et al. in view of Lafferty et al. renders claim 18 obvious. 2. Claims 2-4 are rejected under 35 USC 103 as being unpatentable over Nielsen et al. in view of Lafferty et al. as applied to claim 1 and further in view of International Patent Application Publication No. WO 2009121037 to Carrilho et al. (cited by applicant) II.) Regarding applicant’s claim 2, as noted above Nielsen et al. in view of Lafferty et al Claim 2 recites that the cartridge is configured to provide at least two different sample preparation processes, simultaneously, by splitting the sample between a first set of valves (30, 31) and a second set of valves (32, 33). Nielsen et al. in view of Lafferty et al. does not teach that the cartridge is configured to provide at least two different sample preparation processes, simultaneously, by splitting the sample between a first set of valves (30, 31) and a second set of valves (32, 33). Carrilho et al. teaches a multilayer ed device that can run two assays at the same time. [0060] It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al. in view of Lafferty et al. to configuring the valves and channels to direct a sample to be tested to different channels for purposes of running multiple analysis on the same sample as taught by Carrilho et al. Therefore, Nielsen et al. in view of Lafferty et al. and Carrilho et al. renders claim 2 obvious. II.) Regarding applicant’s claim 3, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 3 depends. Claim 3 recites that the cartridge is configured to provide at least two different sample preparation processes, simultaneously, by splitting the sample between a first set of valves (30, 31) and a second set of valves (32, 33), in that said first set of valves (30, 31) being opened for WBCs enumeration. As noted above Nielsen et al. in view of Lafferty et al. and Carrilho et al. renders it obvious to modify Nielsen et al. in view of Lafferty et al. to configuring the valves and channels to direct a sample to be tested to different channels for purposes of running multiple analysis on the same sample . The recitation in claim 3 regarding WBC enumeration does not incorporate structure limitations into claim 3. Therefore, Nielsen et al. in view of Lafferty et al. and Carrilho et al. renders claim 3 obvious. III.) Regarding applicant’s claim 4, as noted above Nielsen et al. in view of Lafferty et al. renders claim 1 obvious from which claim 4 depends. Claim 3 recites that the cartridge is cartridge is configured to provide at least two different sample preparation processes, simultaneously, by splitting the sample between a first set of valves (30, 31) and a second set of valves (32, 33), in that second set of valves (32, 33) being opened for RBCs enumeration and platelet enumeration. As noted above Nielsen et al. in view of Lafferty et al. and Carrilho et al. renders it obvious to modify Nielsen et al. in view of Lafferty et al. to configuring the valves and channels to direct a sample to be tested to different channels for purposes of running multiple analysis on the same sample . The recitation in claim 4 regarding RBCs enumeration and platelet enumeration does not incorporate structure limitations into claim 4 . Therefore, Nielsen et al. in view of Lafferty et al. and Carrilho et al. renders claim 4 obvious. 3. Claim 9 is rejected under 35 USC 103 as being unpatentable over Nielson et al. in view of Lafferty et al. as applied to claim 1 and further in view of U.S. Patent Application Publication No. 20150137015 to Toh et al. Claim 9 recites that actuation layer (L8) compris es : pillars (46) for closing valves, said pillar extruding from pre-defined positions of base of said actuation layer, each pillar corresponding, in position, with at least a valve of said liquid flow channel layer; and spring loaded clamps (42, 43, 44, 45) configured to displace said actuation layer (L8) towards or away from said liquid flow channel layer (L5) based through said soft membrane (L6). As noted above, Nielson et al. teaches puncturing elements (interpreted as being “needle”) that puncture the frangible seals of the barrels and Lafferty et al. teaches that any suitable known actuator can be used to create valves along the elastomeric membrane(s) and the fluid flow path. In discussions of embodiments having one or more elastomeric membrane(s) that act to define a fluid flow path, any disclosed valving can be accomplished using the toggle clamps of FIG. 38 or other known actuation elements. Also as noted above, Lafferty et al. teaches toggle clamps, plungers and other permanent mechanisms which impart pressure upon different portions of the cartridge to define or obstruct flow paths, and to aid in pumping and directing fluid flow and to permit and restrict fluid from flowing along the fluid flow path. [00118], [00139] Nielsen et al. in view of Lafferty et al. does not specifically teach pillars and spring loaded clamps configured to displace said actuation layer t owards or away from said liquid flow channel layer based through said soft membrane . Toh et al. teaches using a pin to press against a membrane to block fluid in a channel, effectively functioning as a valve. It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Nielsen et al, in view Lafferty et al. to provide pins as taught by Toh et al. to close channels and include spring loaded pins to prevent too much pressed for pressing against the elastomeric membrane so as not to rupture the elastomeric membrane. Therefore, Nielsen et al. in view of Lafferty et al. and Toh et al, renders claim 9 obvious. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MICHAEL S. GZYBOWSKI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3487 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:30-5:00 . 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, Charles Capozzi can be reached at 571-270-3638. 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. /MICHAEL STANLEY GZYBOWSKI/ Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

Oct 25, 2023
Application Filed
Mar 20, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
69%
Grant Probability
99%
With Interview (+52.7%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 139 resolved cases by this examiner. Grant probability derived from career allow rate.

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