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 Arguments
Applicant’s arguments, filed 01/26/26, with respect to the rejection(s) of claim(s) under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter have been fully considered and are persuasive. Applicant has amended claim 9 to address the issue(s) set forth in Paragraph 5 of the Non-Final Rejection mailed 09/26/25. See also page 7 of Applicant’s Remarks. Therefore, the rejection has been withdrawn.
Applicant’s arguments, filed 01/26/26, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 as being unpatentable over Siddiqi (US 2003/0127396) in view of Smith et al. (US 2002/0185457) have been fully considered and are persuasive. Applicant has amended claim 1 to include the limitation “wherein said suction device (12) comprises a preloaded spring and a syringe activated by the preloaded spring; the preloaded spring and the cannula are configured to obtain a water flow speed through said open end (9) up to about 30 mL/min” and then argued that this feature is not taught by the cited prior art, Siddiqi and Smith. See pages 7-9 of Applicant’s remarks. The Examiner agrees; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Inventorship
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 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.
Claims 1-15 and 17-24 are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqi (US 2003/0127396) in view of Smith et al. (US 2002/0185457), and further in view of Lemburg et al. (US 2019/0137365). Siddiqi teaches an apparatus for processing magnetic particles. The embodiments or portions of the device most relevant to the instant claims are shown in Figures 5A-5F and 14A-14D; and described in Paragraphs 0050-0139.
Regarding claims 1, 2, 3, 5, 9, 10, 21 and 22 – As shown in the Figures cited by the Examiner, Siddiqi teaches a system for treating samples having a magnetic device (magnet plate 143 with rows of magnet assemblies 146A, 146B) having a treatment chamber (space formed below apertures 144 of sample plate 144A and between magnet assemblies) and configured to create a magnetic field in the treatment chamber (space formed below apertures 144 of sample plate 144A); a container (Eppendorf type container 145), which is configured to contain a treated sample and to be housed inside said treatment chamber (space formed below apertures 144 of sample plate 144A) and has at least a side wall, a bottom and an opening opposite the bottom (see container 145 of Figures 14A-14D); and a cannula (59A, 59B), which has an open end for removing material from the container (in liquid 58 - see Figure 5C). With respect to the suction device configured to create a depression inside said cannula (59A) so that part of said treated sample is carried through said cannula (59A) out of the container, Siddiq teaches aspirating the fluid from the container in Paragraphs 0103-0106. Siddiq does not teach an alignment device configured to be mounted in a substantially fixed manner in the area of said container (145) and also has a through hole configured to be engaged by said cannula and to keep the cannula in a substantially fixed position and orientation such that the cannula is spaced apart from said side wall of the container (145). Siddiq also does not teach a suction device comprising a syringe and preloaded spring such that the syringe is activated by the preloaded spring.
Smith teaches a centrifuge tube assembly. The device is shown in general in Figures 1-4 and described in Paragraphs 0023-0039. The embodiment of the device most relevant to the instant claims is shown in Figure 8 and described in Paragraphs 0040-0044. As shown in Figure 8, Smith teaches a centrifuge tube (receptacle 12a) having a cap (14a) for closing the tube. The cap (14a) includes an opening (15a) for receiving a cannula (pipe 36a) attached to a syringe for aspirating fluid from the container. Again, see Paragraphs 0042-0043. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the cap, cannula and syringe elements from Smith with the device of Siddiq. Siddiq teaches cannulas for the addition and removal of fluids from a container but does not teach a lid. One of ordinary skill in the art at the time would add the lid and cannula features to Siddiqi to provide a cover for the container while still allowing for addition and removal of fluids to the container as taught by Smith. One of ordinary skill in the art at the time would add the syringe to Siddiqi provide a source of suction for aspiration as taught by Smith. The combination of Siddiqi and Smith does not teach a suction device comprising a syringe and preloaded spring such that the syringe is activated by the preloaded spring.
Lemburg teaches an automated multiple sample processor for fluid samples. The automated processor device is best shown in Figures 1-3 and described in Paragraphs 0016-0035. The processor device includes a plurality of piston pumps (2) which each have a sample opening, a cylindrical housing (syringe 18) and an axially displaceable piston (21) connected to two spiral springs (6,7) and mounted in a support frame (3). The two springs (6,7) are supported in the support frame and are fixable in a tensioned initial position by a lock which may be released to from a position which results in (a) the piston (21) being pushed into the cylinder (18); or (b) the piston being pushed into the cylinder (18) depending on the desired processing feature – suction or ejection. See Paragraphs 0009, 0023-0024, 0032-0033. In Paragraphs 0021-0022, Lemburg teaches the use of preloaded springs for providing a controlled amount of piston displacement and measured volume of fluid when receiving and ejecting the fluid. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the syringes with a preloaded spring from Lemberg with the combined device of Siddiqi and Smith. One of ordinary skill in the art at the time would add the syringes with the preloaded springs to modified Siddiqi in order to provide a controlled amount of piston displacement and measured volume when receiving and ejecting fluids.
Regarding the flow rates recited in claims 1, 5 and 21-23 – The Examiner notes that Lemburg teaches providing a controlled volume of 50 ml of fluid upon activation of their syringe pump in Paragraph 0022. Smith teaches a syringe for providing 50 ml of fluid in Paragraph 0036. The Examiner submits it would have been obvious to one of ordinary skill in the art to determine the preloaded spring tension required for a flow rate of “up to about 30 mL/min or less as recited in the claims through routine optimization. See MPEP 2144.05, Section II – “Routine Optimization”.
Regarding claims 4 and 14 - Siddiqi discloses wash steps and removing the supernatant liquid from the container by aspiration and then transferring it to another suitable collection container for further treatment and testing in Paragraphs 0103-0106.
Regarding claims 5 and 6 - Smith teaches a syringe element in Paragraph 0042 for removing about 50 ml of material (see Paragraph 0036). The Examiner submits the syringe element is capable of sucking up to "about 50mL of liquid" as recited in the claim.
Regarding claim 7 - Smith is silent as to the length of the through hole that surrounds the cannula. The Examiner takes the position that the difference in length of through hole surrounding the cannula is a difference of relative dimensions and the claimed device would not perform differently than the prior art. In Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the through hole length of the claimed device would not perform the function of supporting the cannula differently than the through hole length of the cited prior art, Smith.
Regarding claim 8 - Figure 5C of Siddiqi shows a substantially straight cannula (59A) portion that extends into the (58) fluid in the container. Figure 8 of Smith also teaches a substantially straight cannula (pipe 36a) inserted through the hole (15a) of the alignment device (closure 14a).
Regarding claims 11 - Smith recites a diameter of about 3 mm for the cannula in Paragraph 0030. The Examiner first takes the position that the difference in diameter between the prior art cannula and the diameter of the claimed cannula is one of relative dimensions. In Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the claimed cannula would not perform the function of aspirating material differently than the cannula of the cited prior art, Smith. The Examiner further submits it would also have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to provide a larger cannula diameter in order to process more material through the cannula.
Regarding claims 12 and 15 - Siddiqi recites microspheres with affinity binding compounds including white blood cells and tumor cells in Paragraph 0065.
Regarding claims 13, 17 and 19 - Siddiqi recites a method that includes providing the container having the sample and magnetic particle, placing the container into the magnetic device, positioning the cannula in the container, activating the magnetic field, and then removing the supernatant through the cannula with suction in Paragraphs 0101-0106. See also Figures 5A-5F and the claims.
Regarding claim 18 - Siddiqi teaches processing a cell or blood sample in Paragraph 0065.
Regarding claim 20 - Smith teaches a removable duct (port 32a) which connects the cannula (pipe 36a) to a syringe element or other aspiration device in Paragraphs 0033 and 0042.
Regarding claim 23 – Smith teaches ports comprised of “a relatively durable plastic or glass material” in Paragraph 0030.
Regarding claim 24- Smith shows the port in the through hole with less than 1 mm between the through hole and cannula in Figures 1-2.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Siddiqi (US 2003/0127396) in view of Smith et al. (US 2002/0185457) and Lemburg et al. (US 2019/0137365), and further in view of Ohashi (US 2013/0273552). Siddiqi, Smith and Lemburg teach every element of claim 16 except for the fluorescent particles. Ohashi teaches a device for manipulating magnetic particles for capturing a target component. The embodiment of the device most relevant to the instant claims is shown in Figures 3-5 and described in Paragraphs 0169-0185. Ohashi teaches capturing a target component on a magnetic bead, manipulating the bead to perform a reaction, and then detecting the reaction using a fluorescent dye particle. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the fluorescent dye particles from Ohashi with the teachings of Siddiqi, Smith and Lemburg. One of ordinary skill in the art would add the fluorescent dye to Siddiqi, Smith and Lemburg in order to assay for specific compounds and provide a fluorescent signal as taught by Ohashi.
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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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.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 June 05, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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