DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-3, 8, 9, 12-18, 21, 22, 25, and 38, in the reply filed on May 7, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 26, 27, 29, 31, 33, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings were received on June 29, 2023. These drawings are acceptable.
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.
Claim(s) 1-3, 8, 9, 12-14, 16-18, 21, 22, 25, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collier et al (US 2015/0064707 A1).
With respect to claim 1 Collier discloses a method of extracting or isolating at least one target or component from a fluid comprising a sample having multiple components (Abstract, extraction of nucleic acids from cells, the amplification of segments of nucleic acid and the detection of nucleic acids ... a sample comprising cells containing nucleic acid is exposed to an aqueous mixture comprising a lytic reagent and one or more beads capable of binding the nucleic acid released from said cells to form a nucleic acid-bead complex; Para. [0080] The present disclosure demonstrates a rapid and simple protocol for isolating genomic DNA from whole blood), the method comprising placing a container housing the fluid comprising the sample into a destination fluid that is sufficiently miscible with the fluid comprising the sample (Para. [0086] FIG. 1 shows a tube 1 contains ... a lytic buffer 3 and magnetic beads 4 ... Blood 5 Is introduced with a pipette 6 and the blood is well mixed so that cells lyse in the buffer, i.e. blood is in a pipette container holding a blood sample is placed in a miscible destination buffer), wherein the container comprises an opening that permits movement of particles from the sample to the destination fluid (Para. [0086] FIG. 1 shows a tube 1 contains ... a lytic buffer 3 and magnetic beads 4 ... Blood 5 is introduced with a pipette 6 and the blood is well mixed so that cells lyse in the buffer, i.e. pipette container holding a blood sample includes opening that allows cell particles from blood to enter destination buffer).
With respect to claim 2 Collier discloses wherein the target or component is extracted or isolated by selectively moving particles from the fluid comprising the sample into the destination fluid (Para. [0042] exposing a sample comprising cells containing nucleic acid to an aqueous mixture comprising a lytic reagent and one or more beads capable of binding the nucleic acid released from said cells to form a nucleic acid-bead complex; Para. [0086] FIG. 1 Blood 5 is introduced with a pipette 6 and the blood is well mixed so that cells lyse in the buffer. Nucleic acid 7 then binds to the beads via non-specific surface bonds. A magnet 8 is then used to draw the beads and some extra lysed material and buffer to side of the tube to form a pellet. The magnet is then moved along side the tube to draw the pellet upwards through the wax layer. i.e. e target or component is extracted or isolated by selectively moving particles from the fluid sample in destination fluid).
With respect to claim 3 Collier further discloses wherein the opening permits movement of at least one target or component from the sample to the destination fluid (Para. [0042] exposing a sample comprising cells containing nucleic acid to an aqueous mixture comprising a lytic reagent and one or more beads capable of binding the nucleic acid released from said cells to form a nucleic acid-bead complex; Para. [0086] FIG. 1 Blood 5 is introduced with a pipette 6 and the blood is well mixed so that cells lyse in the buffer. Nucleic acid 7 then binds to the beads via non-specific surface bonds, i.e. pipette opening permits movement of target nucleic acid into destination buffer).
With respect to claim 8 Collier discloses applying a magnetic force to the composition to generate a concentration of target-PMP complexes proximal to the liquid/air interface prior to drawing the target-PMP complexes through the liquid/air interface and into the sample collection device (See Paras. 0082-0084 and Fig. 1).
With respect to claim 9 Collier discloses that the biological sample can be sourced from a buccal swab (See Paras. 0080 and 0102).
With respect to claim 12 Collier discloses that the sample collection device comprises a wash buffer (See Para. 0084 - The entire supernatant of lysed cells was then removed by pipette. A wash buffer, e.g. Dynal wash buffer (from a Dynal kit), was introduced by pipette and used to rinse the bead-DNA pellet that was captured against the tube wall. The wash solution was then entirely removed by pipette while the pellet remained captured against the tube wall).
With respect to claim 13 Collier discloses:
Removing the was buffer from the samp le collection device; and
Adding reagents for detection of the target to the samp le detection device after removal of the wash buffer (See Para. 0084 for discussion of addition of PCR cocktail to the remaining bead-DNA pellet).
With respect to claim 14 Collier discloses that the sample collection device comprises reagents for detection of the target (See Para. 0084 for discussion of addition of PCR cocktail to the remaining bead-DNA pellet).
With respect to claim 16 Collier discloses a layer of mineral oil, wherein the layer of mineral oil floats above the reagents for detection of the target and/or the wash buffer (See Para. 0084 - The remaining bead-DNA pellet was then removed and added to a new tube with a PCR cocktail comprising polymerase enzyme, primers, dNTPs and buffer along with a mineral oil overlay and placed into a conventional thermocycler).
With respect to claim 17 Collier discloses that the biological sample is obtained from a subject suspected of having an infection (See Para. 0193 for discussion of how the system may be used by a physician at the bedside or during a patent’s office visit).
With respect to claim 18 Collier discloses that the subject is suspected of having a viral infection, a viral upper respiratory infection, or an infection due to SARS- CoV2, coronavirus, rhinovirus, influenza, respiratory syncytial virus, adenovirus, parainfluenza, human immunodeficiency virus, human papillomavirus, rotavirus, hepatitis C virus, zika virus, Ebola virus, tuberculosis, borrelia burgdorferi, staphylococcus, aspergillus, or Streptococcus Pyogenes (See Para. 0008 for discussion of detection and analysis of the presence of nucleic acids has become important for the identification of single nucleotide polymorphisms (SNPs), chromosomal rearrangements and the insertion of foreign genes. These include infectious viruses, e.g. HIV and other retroviruses, jumping genes, e.g. transposons, etc.).
With respect to claim 21 Collier discloses that the target comprises a material selected from the group consisting of viral nucleic acids, bacterial nucleic acids, proteins, glycopeptides, antibodies, cells, DNA sequences, RNA sequences, lipids, and carbohydrates (See Para. 0080 for discussion of how genomic DNA can be isolated from whole blood for the primary purpose of performing an amplification reaction).
With respect to claim 22 Collier discloses that the method is automated (See Para. 0085 for discussion of the extraction method being performed as the basis of an automated analysis in a disposable device; also See Para. 0090).
With respect to claim 25 Collier discloses detecting the target within the sample collection device (See Para. 0091 for discussion of detection via the disposable cartridge device).
With respect to claim 38 Collier discloses that the biological sample is mixed with PMPs contained within the pipette tip to generate the composition comprising one or more target-PMP complexes within the pipette tip (See Para. 0084).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collier et al (US 2015/0064707 A1) in view of Maslana et al (US 2013/0259635 A1).
Refer above for the disclosure of Collier.
With respect to claim 15 Collier fails to disclose that the sample collection device comprises a multi-well plate.
Maslana teaches a lab object handling system 100 forms a part of a laboratory liquid handling system 10 (See para. 0037), wherein the system 10 as illustrated includes a platform or deck 12, a frame 20, a controller 30, a human machine interface (HMI) 33, a liquid handler 40, a drive system 50, and a pipetting gantry or module 60. A lab object 160 is disposed on the deck 12. The lab object 160 may include, for example, labware such as a microwell plate, a rack containing one or more vials or another suitable type of liquid container or receptacle (See para. 0038). Pipettors can be used and a controller 30 can place one or more of the tips 82C of the pipettors 72, 74, 76, 78 in or over a volume of a liquid sample (e.g., in a cell or cells of a microwell plate or other container on the deck 12) and the liquid handler 40 can then aspirate and collect liquid from the volume or dispense a material into the volume (See Para. 0075).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the microwell plate of the system of Maslana into the sample collection device of Maslana such another suitable type of liquid container or receptacle can be more readily obtained and manipulated as needed (See Paras. 0038 of Maslana).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 June 13, 2026
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