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 .
Response to Amendment
The amendment filed April 7, 2026 has been entered.
Claims 1-4, 6-7, 14-15, 17, 19-20, 22-23, 26-27, 32, 47-49, 52 and 85-87 are pending, with claims 1-4, 6-7, 14-15, 17, 19-20, 22-23, 26-27, 32, 48-49, and 86-87 being examined, and claims 47, 52, and 85 deemed withdrawn. Claims 88-90 are newly added, and are pending and examined. Claims 5, 8-13, 16, 18, 21, 24-25, 28-31, 33-46, 50-51, and 53-84 are canceled.
Applicant’s amendments to the Claims have not overcome any 112(b) rejection previously set forth in the Non-Final Office Action mailed January 7, 2026. The 112(b) rejections are detailed in Claim Rejections-35 USC 112 section of the instant Office Action.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/20/2026 and 5/6/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 32 is objected to because of the following informalities:
Regarding claim 32, the clause beginning with “a control system” lists 3 different elements as (i), (ii), and (ii). The third element listed (i.e. the one or more hardware storage devices) should be listed as element (iii) to be proper.
Appropriate correction is required.
Claim Interpretation
In claim 22, the limitation “a further elution buffer reservoir” has been examined as part of the purification cartridge. This interpretation is corroborated by at least [0018]-[0019] of the instant Specification.
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 17 and 26 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.
Regarding claim 17, Ln. 2 recites, “a second chamber”. However, none of the previous claims that claim 17 depends on recite a first chamber. Therefore, it is unclear if a first chamber is present, that would necessitate the recited chamber being referred to as a second chamber. Further clarification is needed.
Regarding claim 26, Ln. 2 recites, “a third chamber”. However, the only previous claim that recites a chamber is claim 17, which recites, “a second chamber”. Therefore, it is unclear if a first chamber is present, that would necessitate the recited chamber being referred to as a third chamber. Further clarification is needed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-7, 14-15, 17, 19-20, 22-23, 26-27, 32, 48-49, and 86-90 are rejected under 35 U.S.C. 103 as being unpatentable over Andeshmand et al. (US Pub. No. 2021/0047678; hereinafter Andeshmand; already of record) in view of Regan (US Pub. No. 2008/0213872; already of record).
Regarding claim 32, Andeshmand discloses an apparatus for automated purification of a target biomolecule from a biological sample ([0015], [0192]-[0193], [0342], see Fig. 3). The apparatus comprises:
a casing having an internal compartment configured in size and shape for receiving a purification cartridge (see Fig. 3 at casing 2000).
optionally, a selectively closable access door providing access to the internal compartment (optionally not included).
A pump assembly disposed within the internal compartment and configured to effect motion of fluid within the apparatus ([0251], see Figs. 48-49 at pneumatic subsystem 2130, which is within the instrument enclosure).
Andeshmand fails to explicitly disclose a control system comprising (i) one or more sensors, (ii) one or more processors, and (iii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus.
Regan is in the analogous field of nucleic acid purification cartridges (Regan [0011]). Regan teaches a control system comprising (i) one or more sensors, (ii) one or more processors, and (iii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus (Regan; [0040], [0074]. A bar code reader is a type of sensor, a computer intrinsically has one or more processors, and in order for a protocol to be selected based on the bar code reader reading bar code information on an inserted cartridge, or for the computer to notify a user that the wrong cartridge is installed, the computer must intrinsically have instructions to cause the control system to receive bar code information, i.e. sensor data, and determine one or more process states of the apparatus, i.e. the correct or incorrect cartridge is installed). The one or more sensors include a cartridge scanner (Regan; [0040], [0074]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Andeshmand with the teachings of Regan so that the apparatus comprises a control system comprising (i) one or more sensors, (ii) one or more processors, and (iii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus, to ensure that the proper protocol is performed on a specified cartridge, and to prevent against inserting the wrong cartridge in a specified application (Regan; [0040], [0074]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of modified Andeshmand with the teachings of Regan so that the one or more sensors include a cartridge scanner, as Regan teaches that a cartridge scanner can be used to ensure that the correct cartridge is inserted into the apparatus for a specified application (Regan; [0040], [0074]).
Note: The instant Claims contain a large amount of functional language (ex: “configured in size and shape for receiving a purification cartridge…”, “configured to effect motion of fluid within the apparatus…”, “configured to retain a target biomolecule”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 1, modified Andeshmand discloses the apparatus of claim 32, wherein the purification cartridge comprises:
a bioprocessing assembly including a target-biomolecule-binding filter configured to retain a target biomolecule; and
a receptacle in fluid communication with the bioprocessing assembly, the receptacle configured to receive an output container for receiving the target biomolecule from the bioprocessing assembly (the purification cartridge is not positively recited).
Regarding claim 2, modified Andeshmand discloses the apparatus of claim 1, wherein the purification cartridge comprises a consumable cartridge (the purification cartridge is not positively recited).
Regarding claim 3, modified Andeshmand discloses the apparatus of claim 1, wherein the target biomolecule is a target protein or a target nucleic acid (the purification cartridge, and its associated first and second bioprocessing assemblies for generating a lysate comprising target biomolecule and retaining the target biomolecule, respectively, are not positively recited).
Regarding claim 4, modified Andeshmand discloses the apparatus of claim 1, wherein (a) the purification cartridge further comprises an optical density detector window disposed between the input reservoir and the first bioprocessing assembly, the optical density detector window being configured to allow detection of an optical density of the biological sample, (b) the purification cartridge comprises a clarification filter, or both (a) and (b) (the purification cartridge is not positively recited).
Regarding claim 6, modified Andeshmand discloses the apparatus of claim 4, wherein the clarification filter is in fluid communication with the input reservoir and a lysis buffer reservoir, the clarification filter being configured to separate a target-biomolecule-containing portion of the biological sample from a first waste portion of the biological sample (the purification cartridge is not positively recited).
Regarding claim 7, modified Andeshmand discloses the apparatus of claim 4, wherein the purification cartridge further comprises a cell capture filter disposed upstream of the clarification filter (the purification cartridge is not positively recited).
Regarding claim 14, modified Andeshmand discloses the apparatus of claim 1, wherein the target-biomolecule-binding filter of the bioprocessing assembly comprises a silica-based filter or a column of beads having affinity for the target biomolecule (the purification cartridge is not positively recited).
Regarding claim 15, modified Andeshmand discloses the apparatus of claim 14, wherein (a) the bioprocessing assembly further comprises a purification reagent reservoir in fluid communication with the target-biomolecule-binding filter, (b) the target-biomolecule-binding filter, is in fluid communication with an elution buffer reservoir and the output container, or both (a) and (b) (the purification cartridge is not positively recited).
Regarding claim 17, modified Andeshmand discloses the apparatus of claim 15, wherein the purification cartridge comprises a second chamber disposed between the bioprocessing assembly and the target-biomolecule-binding filter (the purification cartridge is not positively recited).
Regarding claim 19, modified Andeshmand discloses the apparatus of claim 17, wherein the target-biomolecule-binding filter is a nucleic-acid binding filter comprising an anion exchange membrane (the purification cartridge is not positively recited).
Regarding claim 20, modified Andeshmand discloses the apparatus of claim 19, wherein the purification cartridge comprises a further bioprocessing assembly which comprises a precipitator membrane disposed downstream of the anion exchange membrane (the purification cartridge is not positively recited).
Regarding claim 22, modified Andeshmand discloses the apparatus of claim 20, further comprising a further elution buffer reservoir, the elution buffer reservoir being fluidically coupled to the anion exchange membrane to enable elution of a target nucleic acid from the anion exchange membrane, and the further elution buffer reservoir being fluidically coupled to the precipitator membrane to enable elution of the target nucleic acid from the precipitator membrane (the purification cartridge is not positively recited).
Regarding claim 23, modified Andeshmand discloses the apparatus of claim 20, wherein the precipitator membrane is any one or more of (a) configured to separate a waste portion from a target-biomolecule-containing portion of the biological sample, (b) in fluid communication with a precipitation reagent reservoir, the precipitation reagent reservoir optionally comprising isopropanol, and (c) in fluid communication with a wash/desalting solution reservoir, the wash/desalting solution reservoir optionally comprising about 70% ethanol (the purification cartridge is not positively recited).
Regarding claim 26, modified Andeshmand discloses the apparatus of claim 20, wherein the further bioprocessing assembly comprises a third chamber disposed between and in fluid communication with the anion exchange membrane and the precipitator membrane, wherein the third mixing chamber is fluidically coupled to a precipitation reagent reservoir and/or a desalting solution reservoir and is disposed between the precipitator membrane and the precipitation reagent reservoir and/or the desalting solution reservoir (the purification cartridge is not positively recited).
Regarding claim 27, modified Andeshmand discloses the apparatus of claim 1, wherein the purification cartridge is configured to receive from about 5 mL to about 5 L of biological sample (the purification cartridge is not positively recited).
Regarding claim 48, modified Andeshmand discloses the apparatus according to claim 32. Modified Andeshmand fails to explicitly disclose:
That the computer-executable instructions are executable by the one or more processors to cause the control system to at least:
compare the determined process states to a set of different protocols stored within a protocol library;
select a purification protocol from the protocol library based on the determined process states; and
carry out the selected purification protocol by causing one or more instrument actuators of the apparatus to operate according to the selected purification protocol.
Regan further teaches computer-executable instructions that are executable by the one or more processors (Regan; [0040], [0074]) to cause a control system to at least: compare the determined process states to a set of different protocols stored within a protocol library, select a purification protocol from the protocol library based on the determined process states, and carry out the selected purification protocol by causing one or more instrument actuators of the apparatus to operate according to the selected purification protocol (Regan; [0040], [0074]. In order for a protocol to be selected based on the bar code reader reading bar code information on an inserted cartridge, or for the computer to notify a user that the wrong cartridge is installed, the computer must intrinsically have instructions to cause the control system to compare the process states to different protocols stored in a protocol library, i.e. notifying a user that an incorrect cartridge is installed, a cleaning protocol, a screen for respiratory pathogens, etc., selecting the cleaning protocol, and carrying out the selected cleaning protocol by operating specific actuators of the apparatus). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of modified Andeshmand with the teachings of Regan so that the computer-executable instructions are executable by the one or more processors to cause the control system to at least: compare the determined process states to a set of different protocols stored within a protocol library; select a purification protocol from the protocol library based on the determined process states; and carry out the selected purification protocol by causing one or more instrument actuators of the apparatus to operate according to the selected purification protocol. The motivation would have been to ensure that the proper purification protocol is performed on a specified cartridge, and to prevent against inserting the wrong cartridge in a specified application (Regan; [0040], [0074]).
Regarding claim 49, modified Andeshmand discloses the control system of claim 32. Modified Andeshmand further discloses that the one or more sensors include an optical density sensor, an access door sensor, a cartridge proximity or contact sensor, an output container proximity or contact sensor, a cartridge scanner, a timer, a temperature sensor, a weight sensor, a volumetric sensor, or combinations thereof (see Claim 32 above at Regan teaching a cartridge scanner in [0040], [0074]).
Regarding claim 86, modified Andeshmand discloses an apparatus according to claim 32. Modified Andeshmand further discloses a method (Andeshmand; [0327]-[0328], [0342]-[0343]). The method comprises:
causing operation of an apparatus according to claim 32 so as to give rise to a purified form of the target biomolecule (Andeshmand; [0327]-[0328], [0342]-[0343]).
Regarding claim 87, modified Andeshmand discloses the method of claim 86. Modified Andeshmand further discloses that the target molecule is a target nucleic acid (Andeshmand; [0327]-[0328], [0342]-[0343]).
Regarding claim 88, modified Andeshmand discloses the apparatus of claim 32, wherein the biological sample comprises a clinical sample (the biological sample is not positively recited. Nevertheless, Andeshmand teaches a clinical sample in [0427]).
Regarding claim 89, modified Andeshmand discloses the apparatus of claim 88, wherein the biological sample comprises any one or more of plasma, serum, urine, cerebrospinal fluid, and saliva (the biological sample is not positively recited. Nevertheless, Andeshmand teaches the claimed samples in [0427]).
Regarding claim 90, modified Andeshmand discloses the apparatus of claim 32, wherein the biological sample comprises a cell-free fraction (the biological sample is not positively recited. Nevertheless, Andeshmand teaches removing cells from biological samples in [0327], [0335]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-7, 14-15, 17, 19-20, 22-23, 26-27, 32, 48-49, and 88-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,994,528 (hereinafter the reference patent) in view of Regan. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 32 is taught by claim 1 of the reference patent, except that the reference patent is silent on a control system comprising (i) one or more sensors, (ii) one or more processors, and (ii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus.
Regan is in the analogous field of nucleic acid purification cartridges (Regan [0011]). Regan teaches a control system comprising (i) one or more sensors, (ii) one or more processors, and (iii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus (Regan; [0040], [0074]. A bar code reader is a type of sensor, a computer intrinsically has one or more processors, and in order for a protocol to be selected based on the bar code reader reading bar code information on an inserted cartridge, or for the computer to notify a user that the wrong cartridge is installed, the computer must intrinsically have instructions to cause the control system to receive bar code information, i.e. sensor data, and determine one or more process states of the apparatus, i.e. the correct or incorrect cartridge is installed). The one or more sensors include a cartridge scanner (Regan; [0040], [0074]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the reference patent with the teachings of Regan so that the apparatus comprises a control system comprising (i) one or more sensors, (ii) one or more processors, and (iii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus, to ensure that the proper protocol is performed on a specified cartridge, and to prevent against inserting the wrong cartridge in a specified application (Regan; [0040], [0074]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified reference patent with the teachings of Regan so that the one or more sensors include a cartridge scanner, as Regan teaches that a cartridge scanner can be used to ensure that the correct cartridge is inserted into the apparatus for a specified application (Regan; [0040], [0074]).
Claim 1 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 2 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 3 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 4 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 6 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 7 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 14 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 15 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 17 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 19 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 20 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 22 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 23 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 26 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 27 is taught by claim 1 of the reference patent as modified by Regan, as the purification cartridge is not positively recited.
Claim 48 is taught by claim 1 of the reference patent as modified by Regan, except that the reference patent is silent on:
That the computer-executable instructions are executable by the one or more processors to cause the control system to at least:
compare the determined process states to a set of different protocols stored within a protocol library;
select a purification protocol from the protocol library based on the determined process states; and
carry out the selected purification protocol by causing one or more instrument actuators of the apparatus to operate according to the selected purification protocol.
Regan further teaches computer-executable instructions that are executable by the one or more processors (Regan; [0040], [0074]) to cause a control system to at least: compare the determined process states to a set of different protocols stored within a protocol library, select a purification protocol from the protocol library based on the determined process states, and carry out the selected purification protocol by causing one or more instrument actuators of the apparatus to operate according to the selected purification protocol (Regan; [0040], [0074]. In order for a protocol to be selected based on the bar code reader reading bar code information on an inserted cartridge, or for the computer to notify a user that the wrong cartridge is installed, the computer must intrinsically have instructions to cause the control system to compare the process states to different protocols stored in a protocol library, i.e. notifying a user that an incorrect cartridge is installed, a cleaning protocol, a screen for respiratory pathogens, etc., selecting the cleaning protocol, and carrying out the selected cleaning protocol by operating specific actuators of the apparatus). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified reference patent with the further teachings of Regan so that the computer-executable instructions are executable by the one or more processors to cause the control system to at least: compare the determined process states to a set of different protocols stored within a protocol library; select a purification protocol from the protocol library based on the determined process states; and carry out the selected purification protocol by causing one or more instrument actuators of the apparatus to operate according to the selected purification protocol. The motivation would have been to ensure that the proper purification protocol is performed on a specified cartridge, and to prevent against inserting the wrong cartridge in a specified application (Regan; [0040], [0074]).
Claim 49 is taught by claim 1 of the reference patent, as modified by Regan (see the double patenting rejection of claim 32 above, where Regan teaches that the one or more sensors include a cartridge scanner in [0040], [0074]).
Claims 88-90 are taught by claim 1 of the reference patent, as modified by Regan, as the biological sample is not positively recited.
Claims 86-87 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of the reference patent in view of Regan, and further in view of Andeshmand. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 86 is taught by claim 1 of the reference patent as modified by Regan, except that the reference patent is silent on a method comprising:
Causing operation of an apparatus according to claim 32 so as to give rise to a purified form of the target biomolecule.
Andeshmand is in the analogous field of purification cartridges (Andeshmand; [0015], [0192]-[0193], [0342], see Fig. 3). Andeshmand teaches causing operation of an apparatus so as to give rise to a purified form of a target biomolecule (Andeshmand; [0327]-[0328], [0342]-[0343]). The target molecule is a nucleic acid (Andeshmand; [0327]-[0328], [0342]-[0343]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified reference patent with the teachings of Andeshmand to include a method comprising causing operation of the apparatus so as to give rise to a purified form of the target molecule, where the target molecule is a target nucleic acid. The motivation would have been that lysing a biological sample can disrupt cell walls and cell membranes to release nucleic acids from a cell (Andeshmand; [0309], [0327]-[0328]), and providing purified nucleic acids will isolate and/or enrich nucleic acids from a lysed sample (Andeshmand; [0309], [0342]-[0343]), thereby providing nucleic acids suitable for performing molecular diagnostic tests (Andeshmand [0008]).
Claim 87 is taught by claim 1 of the reference patent as modified by Regan, and further in view of Andeshmand (see the double patenting rejection of claim 86 above, where Andeshmand teaches a target nucleic acid and generating a lysate at a first bioprocessing assembly in [0327]-[0328], [0342]-[0343]).
Response to Arguments
Applicant's arguments filed April 7, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 9-11 of their Remarks that the prior art of record, and specifically Regan, does not teach a control system comprising (i) one or more sensors, (ii) one or more processors, and (ii) one or more hardware storage devices having stored thereon computer-executable instructions which are executable by the one or more processors to cause the control system to receive sensor data from the one or more sensors to determine one or more process states of the apparatus. The Examiner respectfully disagrees. Under broadest reasonable interpretation, [0040] and [0074] of Regan teach the claimed limitations, as a bar code reader is a type of sensor, a bar code on a cartridge is sensor data, and the process state of the apparatus, i.e. what protocol is to be performed on the cartridge, or whether an incorrect cartridge has been inserted, as determined based on what the bar code reader senses. Therefore, Regan reads on the limitations in question. See MPEP 2173.01. Further, for a more detailed explanation, please see the rejection of claim 32 in the Claim Rejections-35 USC 103 section of this instant Office Action.
Applicant further argues on Pg. 12 of their Remarks that the instant claims should not be rejected for non-statutory double patenting. However, the Examiner respectfully disagrees, as the instant claims can still be rejected for non-statutory double patenting. For a more detailed explanation, please see the Double Patenting section of this instant Office Action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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.
/JOHN MCGUIRK/Examiner, Art Unit 1798
Prosecution Insights