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 .
Response to Amendment
The Amendment filed 02/26/2026 has been entered. Claims 77-78, 80-81, 83-87, 89, 93-98 are pending in the application. Claims 1-76, 79, 82, 88, and 90-92 are previously cancelled. Claims 77, 78, 85, 96 and 98 are amended.
Status of Objections and Rejections
The rejection of claims 77-78, 80-81, 83-87, 89, and 93-98 under 35 U.S.C. 103 is withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
Applicant's arguments, see pages 6-8, filed 02/26/2026, with respect to the rejection of claims 77-78, 80-81, 83-87, 89, and 93-98 under 35 U.S.C. 103, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The claims contain limitations which are directed to intended uses or capabilities of the claimed invention. These limitations are only given patentable weight to the extent which effects the structure of the claimed invention. Please see MPEP 2114. Note that functional limitations are emphasized in italics herein.
Claim Rejections - 35 USC § 103
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 77-78, 80-81, 86, 93-94, and 96 are rejected under 35 U.S.C. 103 as being unpatentable over Selden et al. (US 20150259672 A1).
Regarding claim 77, Selden teaches a method for processing a stool sample (“Purification of DNA from Biological Sample(s) Collected by a Validated Forensic Collection Swab,” wherein “the unprocessed sample comprises…stool swab”; [0154],[0044]), comprising:
(a) providing a collection unit (a purification cartridge for forensic swab samples; Fig. 7; [0156]) at a first location (the space occupied by the purification cartridge), wherein said collection unit is a standalone unit comprising a housing (A self-contained apparatus; Abstract; See body of instrument 1000 in Fig. 7), and wherein said collection unit comprises a homogenization unit (the eluate homogenization chamber [30]; [0160]; Fig. 8) fluidically coupled to a lysis unit (the lysis reagent reservoir [34]; [0160]; Fig. 8) within said housing (The macrofluidic chambers are in communication with microfluidic features and the macrofluidic chambers are in communication with each other via the microfluidic component; [0131]);
(b) collecting said stool sample from a subject at a second location different than said first location, wherein (casework samples are those that are collected at a crime scene or in connection with an investigation, and reference samples are collected directly from an individual; [0155]);
(c) manually depositing said stool sample into said collection unit at said first location (a BodeSecur swab was manually inserted into the sample collection chamber of the purification cartridge and was locked into place for sample processing; [0157]); and
(d) in said collection unit, automatically (“The cartridge was designed to allow the operator to insert the swab into the chamber and initiate DNA purification without further user manipulation,” wherein “The purification process was initiated by simply pressing a button that starts the automated script that controls the pneumatic drive [1005] on the instrument [1000]”; [0157],[0160]);
(i) homogenizing said stool sample in said homogenization unit to generate a homogenized stool sample (“forced air through eluate homogenization chamber [30] to effect mixing by chaotic bubbling,” wherein the stool sample is within the eluate; [0160]; Fig. 8);
(iii) processing said stool sample to extract or isolate at least one biomolecule from said stool sample (“after all the lysis reagent had been dispensed forced air through swab chamber effect "chaotic bubbling"…This bubbling created turbulent flow around the swab head, mediating cell lysis and the removal of cellular material from the swab head,” wherein the biomolecule is “purified DNA solution”; [0160]); and
(iv) directing said at least one biomolecule to a removable cartridge configured to be removed from said collection unit (the chamber that collects the purified nucleic acid sample may contain a removable nucleic acid storage tube; [0132]) for further processing of said at least on biomolecule (“the nucleic acid solution provided may be transferred for additional analytic steps,” such as when “purified DNA solution in the eluate homogenization chamber [30] was ready for subsequent analysis”; [0132],[0160]; Fig. 8).
Selden fails to teach that said second location is within 1 mile of and at least 1 foot from said first location, (ii) directing said homogenized stool sample to said lysis unit, and (iii) processing said homogenized stool sample in said lysis unit.
Selden leaves the distance between the collection site and purification apparatus unspecified. Where the prior art recognizes two locations for collection and processing, the exact spacing between those locations is a matter of routine optimization absent a demonstrated criticality for the claimed range. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have positioned the purification cartridge at any convenient distance from the sample collection location, including distances between 1 foot and 1 mile depending upon laboratory layout, crime-scene processing logistics, or sample handling protocols (See MPEP 2144.05(II))(A)). Additionally, although Selden performs lysis in the sample collection chamber and subsequently homogenizes the purified DNA solution, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the order and location of these known sample processing operations such that homogenization occurs before lysis and the sample is transferred to a dedicated lysis unit. Homogenization and lysis were both well-known stool and biological sample preparation techniques used to facilitate biomolecule extraction. The claimed sequence merely rearranges known process steps to obtain the same expected result of releasing and recovering nucleic acids from the sample (See MPEP 2144.04(IV)(C)).
Regarding claim 78, Modified Selden teaches the method of claim 77, further comprising transmitting said at least one biomolecule of (d) or a derivative thereof to a third location different than said first location and said second location (Paragraph [0161] states that the purified DNA product is subsequently analyzed using PCR and Genebench analysis equipment which is the third location) wherein at said third location, said at least one biomolecule or said derivative thereof is analyzed to identify at least a portion of said at least one biomolecule or said derivative thereof (Amplified products were separated and detected using NetBio's Genebench; [0161]).
Regarding claim 80, Modified Selden teaches the method of claim 77, wherein said at least one biomolecule comprises a deoxyribonucleic acid (DNA) molecule, and wherein said further processing comprises sequencing said DNA molecule (“to evaluate the DNA generated by the purification cartridge, rapid multiplex PCR reactions were performed,” wherein “the instruments which comprise the claimed inventive apparatus also perform…sequencing”; [0161],[0100]).
Regarding claim 81, Modified Selden teaches the method of claim 77, wherein (d) comprises using one or more beads to extract or isolate said at least one biomolecule (the purification matrix of the claimed apparatus comprises…silica beads, silica magnetic beads…or ion exchange beads; [0045]).
Regarding claim 86, Modified Selden teaches the method of claim 77, further comprising automatically cleaning said collection unit (Wash solution from wash reservoir [29] was pneumatically driven through the purification membrane [41] and into the swab chamber [32]. Washing of the purification membrane with wash buffer was conducted to remove unbound material (including protein) and residual lysis solution; [0160]).
Regarding claim 93, Modified Selden teaches the method of claim 77, wherein (d) comprises lysis of one or more cells in said stool sample (after all the lysis reagent had been dispensed forced air through swab chamber effect "chaotic bubbling"…This bubbling created turbulent flow around the swab head, mediating cell lysis and the removal of cellular material from the swab head; [0160]).
Regarding claim 94, Modified Selden teaches the method of claim 93, wherein said lysis is performed using one or more members selected from the group consisting of ultrasonic lysis, mechanical lysis (bubbling created turbulent flow; [0160]), biological lysis, and chemical lysis (lysis reagent; [0160]).
Regarding claim 96, Modified Selden teaches the method of claim 77, wherein (d) comprises filtering said stool sample or a derivative thereof (All of the lysate and ethanol mixture was pneumatically driven in through interface port [280] through a particulate filter [40]; [0160]).
Claims 83-85, 87, 89, 95, and 97-98 are rejected under 35 U.S.C. 103 as being unpatentable over Selden et al. (US 20150259672 A1), as applied to claim 77 above, and in further view of Amin (US 20190062813 A1).
Regarding claim 83, Modified Selden teaches the method of claim 77.
Modified Selden fails to teach said collection unit comprises a sensing unit comprising a sensor and an electronics unit.
Amin teaches a collection unit (housing unit 1306 or waste collector 501; [0159], [0120]; Figs. 5, 13) comprising a sensing unit (“processing component that can process and/or analyze the raw data produced by the waste analysis component,” as well as processing component, the diagnostic component, and/or the notification component; Amin, [0012][0158]) comprising
a sensor (“waste analysis component can comprise a DNA sequencer that can receive the homogenized and/or amplified portion of a waste sample,” including “Ion semiconductor sequencing” wherein a “hydrogen ion can then trigger an ion sensor”; Amin, [0010][0076]) and
an electronics unit (processing component, the diagnostic component, and/or the notification component; Amin, [0158]).
Amin is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated stool sample processing and biomolecular analysis. Selden already teaches that the extracted “nucleic acid solution may be automatically transferred to other analytic modules within the same instrument,” which would result in an all encompassing device that can both process and analyze the sample ([0132]). Amin also teaches a device with both capabilities and that such analysis can be performed using a sensing unit that analyzes biomolecules and generates results that can be communicated to users, medical professionals, and other electronic devices ([0015]). Such functionality would have been advantageous in Selden’s Examples I-IV when testing for forensics, STI’s, and for other pathogenic diseases. Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the collection unit taught by Selden and incorporated the sensing unit taught by Amin because it would allow the ability to automatically review and transmit sample results in real time, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 84, Modified Selden teaches the method of claim 83, further comprising using said sensor to analyze said at least one biomolecule (The hydrogen ion can then trigger an ion sensor (e.g., an ion-sensitive field-effect transistor). If the deoxynucleotide triphosphate is not complementary to the leading unpaired nucleotide of the target strand, no reaction occurs; Amin, [0075][0076]).
Regarding claim 85, Modified Selden teaches the method of claim 83, wherein said electronics unit of said sensing unit comprises a communication interface for transmitting data of said stool sample or a derivative thereof to an electronic device in communication with said communication interface (“the processing component, the diagnostic component, and/or the notification component transmits the resulting raw data to a remote computing platform (e.g., laptop, desktop, smart phone, the cloud, and so on) for computational processing). In such case, the device can include a transmitter, transceiver, and/or internet connector so as to transmit such data for processing,” wherein “the notification component can communicate (e.g., via a wireless and/or wired connection) the notification component can communicate (e.g., via a wireless and/or wired connection)”; Amin, [0158][0015]).
Regarding claim 87, Modified Selden teaches the method of claim 77,
Modified Selden fails to teach said collection unit comprises a storage unit.
Amin teaches a collection unit (housing unit 1306 or waste collector 501; [0159], [0120]; Figs. 5, 13) comprises a storage unit (a single strand of target DNA can be placed in a microwell along with a DNA polymerase; [0076]).
Amin is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated stool sample processing and biomolecular analysis. Selden already teaches that the extracted “nucleic acid solution may be automatically transferred to other analytic modules within the same instrument,” such as sequencing ([0132]). Amin performs DNA sequencing with the waste collection unit and utilizes microwells to facilitate this (See paragraphs [0075]-[0076]). Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the collection unit taught by Selden and incorporated the microwell storage unit taught by Amin because storing purified DNA in individual wells before transfer to sequencing modules permits sample tracking, parallel processing, and automatic analysis of multiple samples within the same instrument, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 89, Modified Selden teaches the method of claim 87, further comprising storing said at least one biomolecule in said storage unit (a single strand of target DNA can be placed in a microwell along with a DNA polymerase; Amin, [0076]).
Regarding claim 95, Modified Selden teaches the method of claim 94, wherein said lysis comprises mechanical lysis (bubbling created turbulent flow; [0160]).
Modified Selden fails to teach said mechanical lysis is performed using beads.
Amin teaches mechanical lysis is performed using beads (mechanical homogenization (e.g., bead beating; Amin, [0121]).
Amin is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated stool sample processing and biomolecular analysis. Selden already teaches mechanical lysis by creating chaotic bubbling for cell disruption ([0160]). Adding beads to this process would only enhance this action. Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method of Selden and incorporated Amin’s beads into the lysing operation because it would improve the disruption of the cells and release of nucleic acids prior to purification, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 97, Modified Selden teaches the method of claim 87, wherein said storage unit comprises said removable cartridge.
Modified Selden fails to teach said storage unit comprises said removable cartridge.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the collection unit taught by Selden in view of Amin by positioning Selden’s removable nucleic acid storage tube within Amin’s multi-well storage unit because both references store DNA samples for downstream analysis within an integrated processing system and this would have predictably enabled organized storage of purified DNA while allowing individual samples to be selectively removed for further processing, and this involves combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)).
Regarding claim 98, The method of claim 89, wherein said at least one biomolecule is stored in said removable cartridge (removable nucleic acid storage tube; Selden, [0132]).
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 VALERIE SIMMONS whose telephone number is (703)756-1361. The examiner can normally be reached M-F 7:30-4:00.
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, Maris Kessel can be reached on 571-270-7698. 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.
/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
Prosecution Insights