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 .
Terminal Disclaimer
The terminal disclaimer filed on 1/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 11,892,461 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Examiner’s Note: the filed terminal disclaimer has overcome each and every double patenting rejection made in the Non-Final Office Action mailed 10/16/2025.
Response to Amendment
The amendment filed January 16, 2026 has been entered.
Claims 50-69 remain pending in the application, with claims 50-66 being examined, and claims 67-69 deemed withdrawn. Claims 1-49 are canceled.
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 statement (IDS) received on 1/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 50 is objected to because of the following informalities:
Regarding claim 50, Lns. 6-7 recite, “move perpendicular relative to one another”, which is grammatically incorrect. It appears that the above limitation needs to be amended to recite, “move perpendicularly relative to one another” to be grammatically correct.
Appropriate correction is required.
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 50-66 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 50, Lns. 6-7 recite, “said magnet and said assay tube move perpendicular relative to one another”. However, it is unclear which axis of each object is taken into account to show that the magnet and assay tube move perpendicular relative to one another. For instance, if the lateral axis of the assay tube is considered, one pattern of motion may be considered to show that the magnet and assay tube move perpendicularly to one another, while if the longitudinal axis of the assay tube is considered, that same pattern of motion would not be considered to show that the magnet and assay tube move perpendicularly to one another. Further clarification is needed. For purposes of compact prosecution, the above limitation has been examined as meaning that the magnet and the assay tube move such that the magnet moves perpendicularly relative to the longitudinal axis of the assay tube.
Claims 51-66 are rejected as depending on a rejected claim.
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 50-60, 64, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqi (US Pat. No. 6,884,357) in view of Geiges (US Pub. No. 2016/021281; already of record) and Malmquist (US Pat. No. 6,783,993; already of record).
Regarding claim 50, Siddiqi discloses a method for processing a biological sample (Col. 7 Lns. 17-45). The method comprises:
(a) providing an analytic device comprising (ii) at least one block, wherein said at least one block comprises a recess that contains an assay tube comprising said biological sample and a magnetic bead, (iii) a bar, wherein said bar comprises a magnet (Col. 15 Ln. 43-Col. 16 Ln. 22, see Fig. 2 at test tube holder 25 holding test tube 23 containing liquid test medium 28 and magnetic particles 29, and magnet 21 mounted on rotating support 22).
(b) subjecting said bar to horizontal motion such that said magnet and said assay tube move perpendicularly relative to one another, thereby subjecting said magnetic bead to motion within said assay tube to mix said biological sample (Col. 15 Ln. 43-Col. 16 Ln. 22, see Fig. 2, where magnet 21 rotates due to rotation of rotating support 22 to travel around test tube 23. The magnetic particles 29 in the test tube 23 are attracted to the magnet 21, and therefore move in a circularly horizontal motion. At any point during this circular horizontal motion, the magnet 21 is moving in a vector perpendicular to the longitudinal axis of the test tube 23).
Siddiqi fails to explicitly disclose:
The analytical device comprises a housing;
The block and bar are within the housing;
The assay tube comprises a reagent; and
The reagent is mixed within the assay tube.
Geiges is in the analogous field of methods for processing a fluid mixture using magnets (Geiges; [0003], see Fig. 1). Geiges teaches an analytical device comprising a housing, where a block and bar comprising a magnet are within the housing (Geiges; [0039]-[0054], see Fig. 1 at external encasement 6, container 2 with magnetic mixing body 12, and fluids within container 2, and magnets 19, and Fig. 5). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Siddiqi with the teachings of Geiges so that the analytical device comprises a housing, and the block and bar are within the housing. The motivation would have been to shield the contents of the analytical device from the external environment, thereby preventing contamination.
Modified Siddiqi fails to explicitly disclose that:
The assay tube comprises a reagent; and
The reagent is mixed within the assay tube.
Malmquist is in the analogous field of sample preparation (Malmquist; Col. 1 Lns. 5-10, Col. 4 Ln. 33-Col. 5 Ln. 61). Malmquist teaches a container comprising a mixture of fluids including a reagent (Malmquist; Col. 1 Lns. 5-10, Col. 4 Ln. 33-Col. 5 Ln. 61, implicit in Col. 7 Lns. 9-16). The reagent is mixed within the container (Malmquist; Col. 1 Lns. 5-10, Col. 4 Ln. 33-Col. 5 Ln. 61, implicit in Col. 7 Lns. 9-16). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the teachings of Malmquist so that the assay tube comprises a reagent, and the reagent is mixed within the assay tube. The motivation would have been that Malmquist recognizes the importance of homogenizing a biological sample and a reagent to allow a reaction to proceed for subsequent analysis (Malmquist; Col. 1 Lns. 5-10, Col. 4 Ln. 33-Col. 5 Ln. 61), and as the method of Siddiqi is used to mix different fluids using the principles of magnetic attraction (Siddiqi; Col. 15 Ln. 43-Col. 16 Ln. 22, see Fig. 2), one having ordinary skill in the art before the effective filing date of the invention would have been motivated to use the principles of Siddiqi to homogeneously mix a biological sample and a reagent as in Malmquist.
Regarding claim 51, modified Siddiqi discloses the method of claim 50.
Modified Siddiqi fails to explicitly disclose, subsequent to (b), detecting a signal from said biological sample.
Malmquist further teaches, subsequent to (b), detecting a signal from a biological sample (Malmquist Col. 6 Ln. 59-Col. 7 Ln. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the further teachings of Malmquist so that a signal is detected from the biological sample subsequent to (b). The motivation would have been to determine a positive or negative test result (Malmquist Col. 6 Ln. 59-Col. 7 Ln. 3).
Regarding claim 52, modified Siddiqi discloses the method of claim 51, wherein said method prevents a signal drift of said signal (the instantly claimed limitation “wherein said method prevents a signal drift of said signal” is not a positively recited method step. Rather, it is drawn to a result of performing the claimed method. As modified Siddiqi performs the instantly claimed method, it will intrinsically result in preventing a signal drift of said signal, absent persuasive evidence to the contrary).
Regarding claim 53, modified Siddiqi discloses the method of claim 50. Modified Siddiqi further discloses that the bar undergoes linear motion or circular motion (Siddiqi; Col. 15 Ln. 43-Col. 16 Ln. 22, see Fig. 2).
Regarding claim 54, modified Siddiqi discloses the method of claim 50. Modified Siddiqi further discloses that the bar comprises a plurality of magnets, which plurality of magnets comprises said magnet (Siddiqi; Col. 15 Ln. 43-Col. 16 Ln. 22, the magnet 21 may comprise one or more magnets, see Fig. 2).
Regarding claim 55, modified Siddiqi discloses the method of claim 50. Modified Siddiqi further discloses that the magnet is a permanent magnet (Siddiqi; Col. 15 Ln. 43-Col. 16 Ln. 22).
Regarding claim 56, modified Siddiqi discloses the method of claim 50. Modified Siddiqi further discloses that the magnet is an electromagnet (Siddiqi; Col. 15 Ln. 43-Col. 16 Ln. 22).
Regarding claim 57, modified Siddiqi discloses the method of claim 50.
Modified Siddiqi fails to explicitly disclose that said analytic device further comprises at least one heating unit in thermal communication with said at least one block, and wherein said at least one heating unit provides thermal energy to said assay tube through said at least one block.
Malmquist further teaches a heating device that is used to provide thermal energy to a container holding a reaction mixture (Malmquist Col. 5 Lns. 50-61). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the further teachings of Malmquist so that the analytic device further comprises at least one heating unit in thermal communication with said at least one block, and wherein said at least one heating unit provides thermal energy to said assay tube through said at least one block, as Malmquist teaches that heating a reaction mixture can be used to bring a reaction mixture to the appropriate temperature for the desired chemical reaction (Malmquist Col. 8 Lns. 17-33).
Regarding claim 58, modified Siddiqi discloses the method of claim 50.
Modified Siddiqi fails to explicitly disclose that said analytic device further comprises at least one cooling unit in thermal communication with said at least one block, and wherein said cooling unit permits removal of thermal energy from said assay tube through said at least one block.
Malmquist further teaches a cooling device that is used to permit removal of thermal energy from a container holding a reaction mixture (Malmquist Col. 5 Lns. 50-61). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the further teachings of Malmquist so that analytic device further comprises at least one cooling unit in thermal communication with said at least one block, and wherein said cooling unit permits removal of thermal energy from said assay tube through said at least one block, as Malmquist teaches that incorporating a cooling device into a mixing device will ensure a thoroughly mixed, homogeneous reaction mixture (Malmquist Col. 8 Ln. 66-Col. 9 Ln. 28).
Regarding claim 59, modified Siddiqi discloses the method of claim 58.
Modified Siddiqi fails to explicitly disclose that the cooling unit permits removal of said thermal energy using positive pressure that directs a fluid comprising at least a portion of said thermal energy away from said at least one block.
However, Malmquist further teaches directing a fluid comprising at least a portion of thermal energy away from a reaction mixture vessel (Malmquist Col. 8 Ln. 61-Col. 9 Ln. 28, the cooling medium will intrinsically be moved away from the reaction mixture vessel after absorbing heat from the vessel). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the further teachings of Malmquist so that the cooling unit permits removal of said thermal energy by directing a fluid comprising at least a portion of said thermal energy away from said at least one block, as Malmquist teaches that directing cooling fluid into a reaction mixture vessel will ensure a thoroughly mixed, homogeneous reaction mixture (Malmquist Col. 8 Ln. 66-Col. 9 Ln. 28).
Modified Siddiqi fails to explicitly disclose that the fluid is directed using positive pressure.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to choose positive pressure from a finite number of identified, predictable ways to direct a fluid, i.e. it would have been obvious to try using positive pressure to direct the fluid. The motivation would have been that positive pressure, e.g. a fan or a fluid, can be used to controllably direct a fluid towards a location as desired by an operator.
Regarding claim 60, modified Siddiqi discloses the method of claim 50. Modified Siddiqi further discloses that the analytic device further comprises a movable carriage comprising said bar, and wherein said movable carriage translates such that said magnet and said assay tube move relative to one another, thereby subjecting said magnetic bead to motion within said assay tube (Siddiqi; Col. 15 Ln. 43-Col. 16 Ln. 22, see Fig. 2).
Regarding claim 64, modified Siddiqi discloses the method of claim 50.
Modified Siddiqi fails to explicitly disclose that said analytic device further comprises an excitation source that provides excitation energy to said assay tube comprising said biological sample.
Malmquist further teaches an excitation source that process exciting energy to a container comprising a biological sample (Malmquist; Col. 6 Ln. 59-Col. 7 Ln. 3, see Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the further teachings of Malmquist so that the analytic device further comprises an excitation source that provides excitation energy to said assay tube comprising said biological sample, as Malmquist teaches that this excitation source can be used to detect chemical reactions in the samples to determine a positive or negative test answer (Malmquist; Col. 6 Ln. 59-Col. 7 Ln. 3, see Fig. 2).
Regarding claim 66, modified Siddiqi discloses the method of claim 50.
Modified Siddiqi fails to explicitly disclose that the analytic device further comprises a detector that receives emission energy from said biological sample within said assay tube.
Malmquist further teaches a detector that receives emission energy from a biological sample within a container (Malmquist; Col. 6 Ln. 59-Col. 7 Ln. 3, see Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the further teachings of Malmquist so that the analytic device further comprises a detector that receives emission energy from said biological sample within said assay tube. The motivation would have been that Malmquist teaches that this detector can be used to detect chemical reactions in the samples to determine a positive or negative test answer (Malmquist; Col. 6 Ln. 59-Col. 7 Ln. 3, see Fig. 2).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Siddiqi in view of Geiges and Malmquist as applied to claims 50-60, 64, and 66 above, and further in view of Baumgartner et al. (US Pub. No. 2016/0265040; hereinafter Baumgartner; already of record).
Regarding claim 65, modified Siddiqi discloses the method of claim 64.
Modified Siddiqi fails to explicitly disclose that said excitation source comprises one or more light emitting diodes (LEDs).
However, Baumgartner is in the analogous field of devices for testing biological samples (Baumgartner [0001]). Baumgartner teaches an excitation sources that comprises one or more LEDs (Baumgartner [0125]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of modified Siddiqi with the teachings of Baumgartner so that the excitation sources comprise one or more LEDs. The motivation would have been that LEDs can be used to detect the presence of a specific fluorescent marker in a biological sample (Baumgartner [0125]).
Allowable Subject Matter
Claims 61-63 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Siddiqi, Geiges, Malmquist, and Baumgartner teach a method similar to that claimed. However, Siddiqi, Geiges, Malmquist, and Baumgarter do not teach, either alone or in combination with the prior art, that the movable carriage further comprises an excitation filter and an emission filter.
Specifically, although Siddiqi and Geiges, which are considered to be the closest prior art, teach a movable carriage comprising a bar comprising a magnet (see Siddiqi at Col. 15 Ln. 43-Col. 16 Ln. 22, see Fig. 2 at magnet 21 mounted on rotating support 22, and Geiges at [0039]-[0054], see Fig. 1 at magnets 19, which move up or down on actuator 20, and Fig. 5), Siddiqi and Geiges do not teach or suggest, either alone or in combination with the prior art, that the movable carriage comprises an excitation filter and an emission filter, and modifying the movable carriages of Siddiqi or Geiges to comprise an excitation filter and an emission filter would not have been obvious absent impermissible hindsight motivation, as modifying the movable carriages in this way would not have provided any tangible benefit to the movable carriages of either Siddiqi or Geiges. See MPEP 2142.
Claims 62-63 would be allowable for depending on claim 61, an allowable claim.
Response to Arguments
Applicant's arguments filed January 16, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments filed on 1/16/2026 have been considered but are moot because applicant’s arguments are towards the amended claims and not the current grounds of rejection.
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