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 .
Preliminary Remarks
The amendment filed on 07/17/2026 has been entered. Claims 1 and 12 have been amended, no claims have been canceled, and no claims have added. Therefore, claims 1-20 remain pending the application.
Claim Rejections - 35 USC § 112
Claims 1 and 12 have been amended to overcome the 112(b) rejection cited in the Office Action mailed on 05/13/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-4, 10-12, 14-15, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20240209302A1-Hernandez et al (hereinafter “Hernandez”, has an effective filing date as of the provisional application).
Regarding claim 1, Hernandez discloses a microfluidic chip system (system-on-a-chip systems, para. [0088], line 8), comprising: a microfluidic chip (systems, methods, and devices for ex vivo analysis of resected tissue samples, which can be used to provide an improved tumor model, para. [0007], lines 1-4; system-on-a-chip systems, para. [0088], line 8) comprising: a pump configured to pump a fluid media through a fluid circuit (one or more pumps 120 is provided to move perfusate through the fluid circuit 118, para. [0062], lines 5-6); a cell chamber (chamber 104, para. [0058], lines 1-3, Fig. 1A) in the fluid circuit (circuit 118, para. [0062], line 6), the cell chamber supporting a plurality of cells (cells of the tissue sample 110, para. [0071], lines 19-20, where chamber 104 is shown in Fig. 1A supporting cells of tissue sample 110), the cell chamber configured to receive the fluid media including oxygen for exposing the plurality of cells to the fluid media including the oxygen (chamber 104 has at least one inlet 112, through which perfusate can be introduced into an internal volume 106 thereof, and at least one outlet 114, through which perfusate can be extracted from the internal volume 106. The perfusate can comprise blood plasma or culture medium mixed with blood plasma. Optionally, the plasma [with or without culture medium] can be supplemented with one or more drugs, hormones, and/or nutrients [e.g., amino acids or amino acid precursors, glutathione, dextrose, antibiotics, and/or insulin], para. [0058], lines 4-13); and a re-oxygenation chamber configured to add oxygen to the fluid media circulating in the fluid circuit (a gas exchange unit 124 [also referred to as a gas exchanger] can be connected to the external fluid circuit 118, para. [0063], lines 1-3);
Hernandez discloses a platform (sample platform 108, para. [0066], line 3) comprising: a bracket for receiving the microfluidic chip (the sample platform can include one or more structures, not shown, that releasably couple the sample platform 108 to the perfusion chamber 104; for example, the sample platform 108 can include a tissue mount section—bracket to which the tissue sample 110 is mounted, para. [0066], lines 3-8);
Hernandez discloses at least one tapping device, the tapping device configured for actuation to mechanically impact the microfluidic chip to apply a force to the microfluidic chip, the force being sufficient to loosen cells from an inner surface of the fluid circuit (one or more displacement members 144 that can be actuated to move the tissue sample 110 with respect to the viewing port, para. [0074], lines 10-12; further, Hernandez discloses system-on-a-chip systems, para. [0088], line 8).
Regarding claim 3, Hernandez discloses further comprising two tapping devices including the at least one tapping device (one or more displacement members 144 that can be actuated to move the tissue sample 110 with respect to the viewing port, para. [0074], lines 10-12).
Regarding claim 4, Hernandez discloses wherein a first tapping device, of the two tapping devices, is configured to contact a first side of the microfluidic chip, and wherein a second tapping device, of the two tapping devices, is configured to contact a second side of the microfluidic chip (Fig. 1D shows two tapping devices—displacement members 144 on either side of tissue assembly 140, both members 114 are shown in contact with either side of assembly 144, also shown in Fig. 1D; further, Hernandez discloses system-on-a-chip systems, para. [0088], line 8).
Regarding claim 10, Hernandez discloses wherein the microfluidic chip comprises a switch configured to enable sampling or disable sampling of the fluid media of the fluid circuit (a sampling device 136 can also be connected to the external fluid circuit 118 by way of connection 134; for example, connection 134 can comprise a valve [e.g., a multi-position valve], a union [e.g., a Y-junction], a withdrawal port, or any other fluidic structure that allows removal of a portion of the perfusate in fluid circuit 118, para. [0065], lines 1-6; further, Hernandez discloses the control system 122 can be operatively coupled to the outlet valve to effect control thereof, para. [0063], lines 24-25; further, Hernandez discloses a control system 122 (also referred to as a controller) may be provided within or external to the environmental control apparatus 102. The control system 122 can be coupled to the environmental control apparatus 102, as well as other components of system 100, for controlling operation thereof, either automatically or in response to commands from a user, for example, via a physical user interface, e.g., buttons, switches, knobs, etc., para. [0057], lines 6-13).
Regarding claim 11, Hernandez discloses further comprising a controller configured to automatically actuate the at least one tapping device (a control system 122; also referred to as a controller; may be provided within or external to the environmental control apparatus 102. The control system 122 can be coupled to the environmental control apparatus 102, as well as other components of system 100, for controlling operation thereof, either automatically or in response to commands from a user, para. [0057], lines 6-12).
Regarding claim 12, Hernandez discloses a microfluidic chip platform, (system-on-a-chip systems, para. [0088], line 8; systems, methods, and devices for ex vivo analysis of resected tissue samples, which can be used to provide an improved tumor model, para. [0007], lines 1-4; system-on-a-chip systems, para. [0088], line 8) comprising: a bracket for receiving a microfluidic chip (the sample platform can include one or more structures, not shown, that releasably couple the sample platform 108 to the perfusion chamber 104; for example, the sample platform 108 can include a tissue mount section—bracket to which the tissue sample 110 is mounted, para. [0066], lines 3-8); and at least one tapping device (one or more displacement members 144 , para. [0074], line 10), the tapping device configured for actuation to mechanically contact the microfluidic chip any apply a force to the microfluidic chip, the force being sufficient to loosen cells from an inner surface of a fluid circuit of the microfluidic chip when the microfluidic chip is received within the bracket (one or more displacement members 144 that can be actuated to move the tissue sample 110 with respect to the viewing port, para. [0074], lines 10-12; further, Hernandez discloses system-on-a-chip systems, para. [0088], line 8).
Regarding claim 14, Hernandez discloses further comprising two tapping devices including the at least one tapping device (one or more displacement members 144 that can be actuated to move the tissue sample 110 with respect to the viewing port, para. [0074], lines 10-12).
Regarding claim 15, Hernandez discloses wherein a first tapping device, of the two tapping devices, is configured to contact a first side of the microfluidic chip, and wherein a second tapping device, of the two tapping devices, is configured to contact a second side of the microfluidic chip (Fig. 1D shows two tapping devices—displacement members 144 on either side of tissue assembly 140, both members 114 are shown in contact with either side of assembly 144, also shown in Fig. 1D; further, Hernandez discloses system-on-a-chip systems, para. [0088], line 8).
Regarding claim 20, Hernandez discloses further comprising a controller configured to automatically actuate the at least one tapping device (a control system 122; also referred to as a controller; may be provided within or external to the environmental control apparatus 102. The control system 122 can be coupled to the environmental control apparatus 102, as well as other components of system 100, for controlling operation thereof, either automatically or in response to commands from a user, para. [0057], lines 6-12).
Allowable Subject Matter
Claims 2, 5-9, 13, and 16-19 objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 2, the prior art fails to teach or fairly suggest at least one tapping device comprising: an arm that extends from a hinge, the hinge being coupled to the platform; a tapping head at an end of the arm, the tapping head configured to contact the microfluidic chip when the microfluidic chip is seated in the platform; wherein the arm pivots around the hinge to move the tapping head to contact the microfluidic chip, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest at least one tapping device comprising: an arm that extends from a hinge, the hinge being coupled to the platform; a tapping head at an end of the arm, the tapping head configured to contact the microfluidic chip when the microfluidic chip is seated in the platform; wherein the arm pivots around the hinge to move the tapping head to contact the microfluidic chip.
The following is a statement of reasons for the indication of allowable subject matter: for claim 5, the prior art fails to teach or fairly suggest wherein the first side is orthogonal to the second side, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest wherein the first side is orthogonal to the second side.
The following is a statement of reasons for the indication of allowable subject matter: for claim 6, the prior art fails to teach or fairly suggest the platform further comprising markings that specifies a distance for moving the at least one tapping device, the distance corresponding to an amount of force for contacting the microfluidic chip with the at least one tapping device, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest the platform further comprising markings that specifies a distance for moving the at least one tapping device, the distance corresponding to an amount of force for contacting the microfluidic chip with the at least one tapping device.
The following is a statement of reasons for the indication of allowable subject matter: for claim 7, the prior art fails to teach or fairly suggest wherein the platform comprises a stopper that prevents the at least one tapping device from applying a force to the microfluidic chip that is over a threshold amount of force, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest wherein the platform comprises a stopper that prevents the at least one tapping device from applying a force to the microfluidic chip that is over a threshold amount of force.
The following is a statement of reasons for the indication of allowable subject matter: for claim 8, the prior art fails to teach or fairly suggest wherein the at least one tapping device comprises a plunger, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest wherein the at least one tapping device comprises a plunger.
The following is a statement of reasons for the indication of allowable subject matter: for claim 9, the prior art fails to teach or fairly suggest wherein the plunger is in communication with a linear actuator configured to cause the plunger to move and tap the microfluidic chip, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest wherein the plunger is in communication with a linear actuator configured to cause the plunger to move and tap the microfluidic chip.
The following is a statement of reasons for the indication of allowable subject matter: for claim 13, the prior art fails to teach or fairly suggest the at least one tapping device comprising: an arm that extends from a hinge, the hinge being coupled to the platform; a tapping head at an end of the arm, the tapping head configured to contact the microfluidic chip when the microfluidic chip is seated in the platform; wherein the arm pivots around the hinge to move the tapping head to contact the microfluidic chip, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest the at least one tapping device comprising: an arm that extends from a hinge, the hinge being coupled to the platform; a tapping head at an end of the arm, the tapping head configured to contact the microfluidic chip when the microfluidic chip is seated in the platform; wherein the arm pivots around the hinge to move the tapping head to contact the microfluidic chip.
The following is a statement of reasons for the indication of allowable subject matter: for claim 16, the prior art fails to teach or fairly suggest further comprising markings that specifies a distance for moving the at least one tapping device, the distance corresponding to an amount of force for contacting the microfluidic chip with the at least one tapping device, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest further comprising markings that specifies a distance for moving the at least one tapping device, the distance corresponding to an amount of force for contacting the microfluidic chip with the at least one tapping device.
The following is a statement of reasons for the indication of allowable subject matter: for claim 17, the prior art fails to teach or fairly suggest further comprising a stopper that prevents the at least one tapping device from applying a force to the microfluidic chip that is over a threshold amount of force, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest further comprising a stopper that prevents the at least one tapping device from applying a force to the microfluidic chip that is over a threshold amount of force.
The following is a statement of reasons for the indication of allowable subject matter: for claim 18, the prior art fails to teach or fairly suggest wherein the at least one tapping device comprises a plunger, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest wherein the at least one tapping device comprises a plunger.
The following is a statement of reasons for the indication of allowable subject matter: for claim 19, the prior art fails to teach or fairly suggest wherein the plunger is in communication with a linear actuator configured to cause the plunger to move and tap the microfluidic chip, where the limitations are in combination with the claim as a whole.
The closest prior art is US2024/0209302A1 (hereinafter “Hernandez”). Hernandez teaches ex vivo analysis can be performed by mounting a portion of live tissue resected from a patient on a sample platform. Using the sample platform, the resected tissue portion can be positioned within a perfusion chamber. Perfusate is flowed through the perfusion chamber and into contact with the resected tissue portion such that diffusion of oxygen occurs between the perfusate and the resected tissue portion. However, Hernandez does not teach or fairly suggest wherein the plunger is in communication with a linear actuator configured to cause the plunger to move and tap the microfluidic chip.
Response to Arguments
Applicant the status of the claims on the top of 5 of their remarks, as well as a summary of the interview that was held on 06/30/2026 for the instant application. Additionally, applicant discussed the 112(b) rejection of claims 1-20 and the amendment to overcome said rejection. Applicant’s remarks regarding the U.S.C. 102 rejection of claims 1,3-4, 10-12, 14-14, and 20 begin on the bottom of page 5 of their remarks. Applicant's arguments filed 07/17/2026 have been fully considered but they are not persuasive for the reasons discussed below in this section. Regarding the bottom of page 5 of applicant’s remarks, applicant discuses paragraph [0074], lines 10-12 of the primary reference of Hernandez and para. [0088], line 8 of the same reference (cited on page 4 of the Office Action mailed on 05/13/2026.
On the top of page 6 of applicant’s remarks, applicant asserts Hernandez does not teach or render the claimed tapping device configured to apply a force sufficient to loosen cells from an inner surface of the fluid circuit of a microfluidic chip. Further, applicant asserts the displacement members 144 of Hernandez are used to move a tissue sample 110 with respect to a view port. Also, applicant asserts “members of Hernandez position different portions of the tissue sample 110 with respect to a focal plane…”. In response, the latter argument is not found persuasive because as discussed during the interview, the displacement members 144 can be actuated to move the tissue sample 110 from a first configuration 154a to a second configuration 154b. That is, albeit the sample is moved with respect to a viewing port, as discussed by applicant, the displacement members 144 are nevertheless moving the tissue sample 110. Moreover, the actuation of the tissue sample 110 by the displacement members therefore results in a force mechanically impacted on the device as discussed above. The movement or actuation by the displacement members 144 of Hernandez results in movement of the tissue sample, which continues to read on the limitation(s) of claim 1 of the instant application. Moreover, applicant has not adequately conveyed in the amended claim nor provided support or discussion of how or what causes the claimed tapping device to actuate and/or tap the microfluidic chip, also discussed during the interview. For the reasons discussed above in this section, the claims discussed above in the rejection stand rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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.
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/LENORA A ABEL/Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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