CTNF 18/289,431 CTNF 90110 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Pursuant to the preliminary amendment dated 6/17/2024, claims 4, 6, 10, 11, 14, 16-21, 26-33 and 35-38 are cancelled and claim 15 is amended. No claims are newly added. Claims 1-3, 5, 7-9, 12, 13, 15, 22-25 and 34 are pending in the instant application and are examined on the merits herein. Priority The application is a National Stage entry of PCT/US2022/27771 filed on 5/2/2022, which claims priority to provisional application 63/184857 filed on 5/6/2021. Information Disclosure Statement The information disclosure statements (IDS) dated 1/24/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 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. 07-20-aia AIA 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 of this title, 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. 07-20-02-aia AIA 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. 07-23-aia AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. 07-21-aia AIA Claim s 1-3, 5, 7-9, 12, 13, 15, 22-35 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Ohashi et al. (US 2013/0273552A1, IDS), in view of King et al. (WO 2001/11336A, PTO-892), further in view of Kelso et al. (US 2009/0246782A1, PTO-892) . Ohashi et al. discloses a multilayered composition for manipulation of liquid biological samples, where the multilayered composition has the structure as shown below. (Figure 1(3); ¶0071-0076) PNG media_image1.png 611 176 media_image1.png Greyscale The multilayered composition comprises a tubular reaction vessel. Within the tubular reaction vessel are a plurality of layers/components: The manipulation substructure A comprises a space, 5, for supplying a target sample, a component 6 which is a collection of magnetic particles, each of layer 3 l is a liquid layer, each of layer 3g is a gel layer and layer 2g is a gel sealing layer, where for manipulation substructure A each end is open and capable of being reversibly sealed; The recovery substructure B comprises a space, b, for receiving the product from the manipulation substructure A and layer 4 which is a recovery medium. Each gel layer comprises a mixture of an oil, including liquid paraffin, and a gelating agent, such as fatty acid esters, which at room temperature is solid, but transitions into a liquid at higher temperatures. Ohashi discloses an embodiment where the multilayered composition is used for extraction, isolation and purification of nucleic acids such that the uppermost layer 3 l is a cell lysis layer, an intermediate layer 3 l is a wash layer and the lowermost layer 4 is an elution layer. (¶0182) Ohashi teaches that the 3 l layers may be in the form of a liquid or hydrogel. (¶0062-0063) Ohashi also envisions that the intermediate layers may be configured for repeated washing such that there are wash layers 3 l 1, 3 l 2, 3 l 3, etc. separated by corresponding gel layers 3g1, 3g2, 3g3, etc. (¶0182) Ohashi discloses that the magnetic particles are not particularly limited as long as they are particles that respond to magnetism and teaches that the particles may be coated with titanium oxide. (¶0163, 0189) Ohashi also envisions that the plurality of gel layers, 3g, may be configured with different compositions such that upper layer(s) may be heated to transition from gel state to sol state, while lower layers(s) remain in a gel state. (¶0089) Ohashi exemplifies a process for extracting and purifying nucleic acids from whole blood where whole blood is added to the uppermost layer 3 l 1 comprising a lysis solution and magnetic particles, where the free nucleic acid resulting from cell lysis binds with the magnetic particles. The magnetic particles are then gathered into a pellet using a moveable magnetic device, where the moveable magnetic device translates the pellet downwards through gel layer 3g1 into wash layer 3 l 2, which is then repeated by further downward translation through wash layer/gel layer pairs 3g2/3 l 3 and 3g3/3 l 4. Finally the magnetic device downward translates the washed pellet through gel layer 2g into eluent layer 4, thereby releasing and isolating nucleic acids from the whole blood sample. (Example 1; Figure 3) Given that the instant waxes are prepared using mixtures of paraffin and oils, the gel layers of Ohashi being comprised of mixtures of paraffin and fatty acid esters meet the limitation of being a “wax”. Ohashi does not teach that the lysis layer is in the form of a paste. Ohashi does not exemplify or claim a method of isolating nucleic acids where the gel layers are manipulated by an external heater to melt sequentially such that upper layers melt before lower layers, as temperature is increased. King et al. discloses a method of manipulating a biological sample, in particular nucleic acids, where the sample is loaded onto a tubular device comprising alternating layers of reagents and waxes, where the composition of the wax layers is formulated such that the upper wax layers melt at temperatures lower (e.g. 55°C) than lower wax layers (e.g. 70-94°C), which enables the operator to control a sequential series of chemical reactions where the sample interacts with a first reagent (e.g. cell lysis buffer) upon melting of the uppermost wax layer, while the layer immediately below remains isolated by the next lowest solid wax layer, then increasing the temperature in steps such that each wax layer melts in sequence enabling contact with a second reagent then optionally a third reagent, in series. (pp. 6-7; claims 22-29; Example 2) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method for isolation of nucleic acids disclosed by Ohashi, such that a heater is employed to sequentially melt each gel layer in series, thereby arriving at the instant invention. One would be motivated to modify Ohashi in this manner because Ohashi suggests that the plurality of gel layers, 3g, may be configured with different compositions such that upper layer(s) may be heated to transition from gel state to sol state, while lower layers(s) remain in a gel state. This suggestion combined with the guidance in the analogous art of King, for how the formulate wax layers to melt sequentially and how to configure the device to enable heating in steps, particularly for application to manipulation of nucleic acids from biological samples, renders the instant claims prima facie obvious. Kelso et al. discloses a method for extracting and isolating nucleic acids where a biological sample containing the desired nucleic acids is sequentially exposed to lysis, magnetic particle binding, washing and elution via a series of reagent wells where the sample is magnetically moved in and out of the wells using an upper liquid wax layer as a bridge between wells. (Figure 2) PNG media_image2.png 200 611 media_image2.png Greyscale Kelso also exemplifies that the lysis reagent may be in the form of a slurry. (¶0244) A slurry is a semi-solid medium which meets the limitation of a “paste”. It would be obvious to modify the device and method of Ohashi by employing the lysis slurry of Kelso, with a reasonable expectation of equivalent results. Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST. 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, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /DALE R MILLER/Primary Examiner, Art Unit 1693 Application/Control Number: 18/289,431 Page 2 Art Unit: 1693 Application/Control Number: 18/289,431 Page 3 Art Unit: 1693 Application/Control Number: 18/289,431 Page 4 Art Unit: 1693 Application/Control Number: 18/289,431 Page 5 Art Unit: 1693 Application/Control Number: 18/289,431 Page 6 Art Unit: 1693 Application/Control Number: 18/289,431 Page 7 Art Unit: 1693 Application/Control Number: 18/289,431 Page 8 Art Unit: 1693
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