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 argument/remarks filed on 08/03/2026 regarding claim objection and 35 U.S.C. 112 rejections have been fully considered and accepted. The claim objection and 35 U.S.C. 112 rejection of 05/06/2026 has been withdrawn.
Applicant's arguments of the 35 U.S.C. 103 rejections filed 08/03/2026 have been fully considered but they are not persuasive.
Applicant’s argument is quoted below:
“However, this is incorrect. As shown below, figure 1 clearly illustrates a configuration in which chambers 2 and 7 are not, and cannot be, fluidly coupled to each other, either via valve 5 or otherwise. As Baston itself explains, valve 5 comprises two liquid pathways and a calibrated-volume channel 82. The first liquid pathway makes it possible to link the conduits C1 and C3 via the calibrated-volume channel.”3 This simply links dilution reagent dispenser 4 to needle 6. It does not fluidly couple either chamber 7 or chamber 2 to anything, let alone each other. Similarly, the second liquid pathway “makes it possible to link the conduits C2 and C4 via the calibrated-volume channel 8,"4 which links dilution reagent dispenser 4 to chamber 7, but does not involve chamber 2 at all, and therefore cannot couple first and second chambers as required by amended claim 1. Accordingly, the applicant submits that the cited art cannot properly be treated as covering the features of amended claim 1, and so requests that the rejection of that claim under 35 U.S.C. § 103 be reconsidered and withdrawn.”
In response to the argument above, examiner’s position was and remains the same in that the invention of Baston allows for the first and second chambers to be selectively fluidly coupled to each other since Baston teaches valve 5, calibrated volume channel 8 as well as the common “Dispenser of dilution reagent” 4 that is coupled as seen at Figs. 1 – 6. In particular, the valve 5 allows fluid communication between the two chambers 2 and 7 through the pathways 8 as can be seen: First, at Figs. 1 – 4, through conduits C1 and C3 by the use of the needle 6 which allows the mixture of the blood with the dilution reagent to form the “first-dilution liquid” as described at page 11, lines 20 – 31, and at Figs 4 illustrate the portion of the first dilution collected from the first chamber 2 being filled into C1, C3 and 8. Second, as illustrated at Fig. 5, the channel 8 filled with the first-dilution liquid (i.e., from chamber 2) is switched from the first liquid pathway to the second liquid pathway, then the liquid being injected into the second chamber 7 through conduits C2, C4, 8 as also described at page 11, line 33 – page 12, line 8. Therefore, examiner believes that the two chambers are “fluidly coupled to each other” as claimed.
Applicant’s arguments regarding claim 10, see pages 8 – 9 (of claim 10), filed 08/03/2026, with respect to the rejection(s) of claim(s) 10 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection of claim 10 has been withdrawn.
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.
Claim 14 is 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.
As to Claim 14, the instant claim recites the limitation “a sample mixture” in line 14. It is vague/unclear if this “sample mixture” is related to the “biological sample” (line 4) and/or “fluid medium” (line 8) or if “sample mixture” (line 14) is a separate mixture formed by either of the “biological sample” (line 4) and/or “fluid medium”. It is unclear as to what the nexus is between “a sample mixture” (line 14) and “biological sample” (line 4) and “fluid medium” (line 8) if any? Thus, resulting in unclear scope of the claim.
Due to claim dependency, all dependent claims thereof are also rejected (i.e., claims 15 – 18).
Claim Rejections - 35 USC § 103
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.
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) 1 – 5, 7 - 9, 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/019267 A1 to Baston, Florent et al. (hereinafter “Baston”) in view of U.S. Patent Application Publication No. 2022/0011328 A1) to Lawrence et al. (hereinafter “Lawrence”).
Regarding Claim 1, Baston teaches a biological analysis system (see Fig. 1, see abstract describing an apparatus for analysis of a blood sample) comprising:
a probe (see needle 6, Fig. 1, see page 10, lines 21 – 24) configured to dispense a biological sample into a first chamber (see page 11, lines 12 – 21 describing the needle 6 used to collect blood from a tube of whole blood 10, then the needle 6 is moved into the first chamber 2 to inject all of the collected blood into the chamber 2);
a pump (see “aspiration system” described at page 8, lines 6 – 9, and/or see “precision pistons/syringes” described at page 6, lines 17 – 22 and/or see element 4, “Dispenser of dilution reagent”, Figs. 1 – 5 which aid in dispensing, aspirating, conveying the fluid sample and mixture through the respective conduits C1 – C4) configured to:
convey a first delivery of diluent to the first chamber for mixing with the biological sample to produce a sample mixture (see arrangement and fluid flow path at Fig. 3, see page 11, lines 20 – 26 describing injection of the blood into chamber 2 is continued so as to fill up with the dilution reagent contained in the first liquid pathway C1, thus forming mixture of the blood and the dilution reagent),
aspirate a portion of the sample mixture from the first chamber (see arrangement and fluid flow path at Fig. 4, see page 11, lines 28 – 31 describing, a portion of the first dilution is collected from the first chamber), and
convey the portion of the sample mixture to a second chamber (see arrangement and fluid flow path at Fig. 5, see page 11, line 33 – page 12, lines 1 – 8, describing the portion of the sample mixture conveyed to a second chamber 7 through the channel 8).
Insofar as Baston may be construed as not explicitly stating a “pump”, Baston does teach “an aspiration system”, “precision pistons/syringes” (which is not illustrated in the figures but described at page 8, lines 6 – 9 and page 6, lines 17 – 22, respectively) as well as element 4 “Dispenser of dilution reagent” in Figs. 1 – 5 which aid in conveying, aspirating and dispensing of the fluid through the respective conduits C1 – C4 as described above.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize a pump as the aspiration system or pistons/syringes or 4, Fig.1 of Baston, since it is known in the art that aspiration systems are designed to generate vacuum or negative pressure and may be designed to use pumps in order to draw a desired amount of fluid.
In addition, Lawrence, in the field of devices, systems and methods for medical diagnostic analysis of a sample, teaches that it is known to use a pump configured to convey and aspirate in the system (see paragraph [0008] describing use of a sample pump configured to perform a first plurality of tasks including, aspirating sample into the sample probe, dispensing sample from the sample probe into the first mixing chamber, dispensing sample from the sample probe into a second mixing chamber, delivering first sample-dilution fluid mixture to a flow cell, and delivering second sample-dilution fluid mixture to the flow cell, see also Fig. 6 illustrating sample pump 210, see additional pumps 220 – 240, 400, see paragraphs [0081], [0083], [0090] – [0091]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use pump system of Lawrence into Baston, in order to allow precise and consistent aspiration, dispensing and conveying of samples into and out of the system.
Baston in view of Lawrence as modified above teaches wherein the first and second chambers are configured to be selectively fluidly coupled to each other (see arrangement at Fig. 1 of Baston which illustrates chambers 2 and 7 being selectively fluidly coupled via valve 5, note that the operation of the device as seen at Fig. 1 allows chambers 2 and 7 to be selectively fluidly coupled as claimed, see steps at page 11, line 20 – page 12 line 8 and Figs. 1 – 5, hence reading on the invention as claimed).
Regarding Claim 2, Baston as modified above teaches wherein the probe (6) is configured to aspirate the biological sample from a biological specimen prior to dispensing the biological sample into the first chamber (see page 11, lines 12 – 21 describing the needle 6 used to collect blood from a tube of whole blood 10, then the needle 6 is moved into the first chamber 2 to inject all of the collected blood into the chamber 2, hence reading on the invention as claimed).
Regarding Claim 3, Baston as modified above teaches further comprising a complete blood count (CBC) drip chamber, wherein the CBC drip chamber is configured to count blood cells within at least one of the first or second chambers (see page 3, lines 1 – 17 describing the analysis comprising optical measurement for counting particles, wherein the optical measurement can take place on an optical bench or in the chamber, see also page 4, lines 1 – 6, page 12, lines 18 – 30, hence reading on the invention as claimed).
Regarding Claim 4, Baston in view of Lawrence as modified above teaches wherein the pump is configured to convey a second delivery of diluent to the second chamber while conveying the portion of the sample mixture to the second chamber (see page 11, line 28 – page 12, lines 1 – 8 of Baston, describing conveying of the diluted sample mixture from the first chamber 2 to the second chamber 7 with through the calibrated volume channel 8, see also use of syringe pumps as modified in view of Lawrence in claim 1 above, hence reading on the invention as claimed).
Regarding Claim 5, Baston in view of Lawrence as modified above teaches further comprising a lyse pump, wherein the lyse pump is configured to convey a lyse to the first chamber (see page 7, lines 13 – 15 and page 12, lines 9 – 13 of Baston describing injection of lysis solution into the first chamber, see also paragraph [0087] of Lawrence describing pulling sample of for instance slug of lysed whole blood through hemoglobin detection cell 610 by use of the system including the pump 400, Fig. 6, see modification above).
Regarding Claim 7, Baston as modified above teaches further comprising a transfer line (see calibrated-volume channel 8, Figs. 1 – 6 of Baston) configured to selectively fluidly couple the first (2) and second (7) chambers to each other (see arrangement and fluid communication between the first and second chambers 2, 7, respectively through the channel 8 at Figs. 1 – 6 of Baston), wherein the pump is configured to aspirate the portion of the sample mixture into the transfer line (see Fig. 4, page 11, lines 28 - 31 of Baston) prior to conveying the portion of the sample mixture to the second chamber through the transfer line (see page 11, line 28 – page 12, lines 1 – 2, describing the calibrated volume channel 8 being filled with the first-dilution liquid before being conveyed to the second chamber through the channel 8, see Figs. 4 5 of Baston).
Regarding Claim 8, Baston in view of Lawrence as modified above teaches further comprising a pair of transfer line valves positioned along a transfer line configured to selectively fluidly couple the first and second chambers (see sampling valve 5 comprising two liquid pathways and a calibrated-volume channel 8, Fig. 1, see page 10, lines 25 – 35 of Baston, see Figs. 1 – 5 of Baston illustrating selectively fluidly coupling the first chamber and the second chamber as claimed, and/or see multiple valves of Lawrence illustrated at Fig. 6 described at paragraph [0090] of Lawrence), wherein the pair of transfer line valves are spaced apart from each other by a transfer line portion (see Fig. 1 of Baston, see Fig. 6 of Lawrence), wherein the transfer line portion has a fixed volume such that the transfer line portion is configured to receive the portion of the sample mixture having a predetermined volume substantially equal to the fixed volume of the transfer line portion (see page 10, lines 25 – 35 of Baston stating “this calibrated-volume channel 8 is a conduit suitable for switching from one liquid pathway to the other and forms a reservoir of fluid, the volume of which is very precisely predetermined. A predetermined quantity of liquid can thus be sent from one liquid pathway to the other”).
Regarding Claim 9, Baston in view of Lawrence as modified above teaches wherein each transfer line valve of the pair of transfer line valves includes a three-way valve (see 5, 8, Fig. 1 of Baston which has two inlets such as C1, C2 and an outlet such as C3 depending on the setting, see multiple valves Fig. 6 of Lawrence which also includes two inputs and an output at various instances including 914, 916, Fig. 6 of Lawrence, hence reading on the invention as claimed).
Regarding Claim 20, Baston teaches a method of analyzing a biological sample (see Fig. 1, see abstract describing an apparatus and method for analysis of a blood sample), comprising:
conveying a diluent to a first chamber via a first pump (see Figs. 1 – 3, see page 11, lines 8 – 26 describing conveying diluent in the pathways as well as first chamber 6, see “aspiration system” described at page 8, lines 6 – 9, and/or see “precision pistons/syringes” described at page 6, lines 17 – 22 and/or see element 4, “Dispenser of dilution reagent”, Figs. 1 – 5 which aid in dispensing, aspirating, conveying the fluid sample and mixture through the respective conduits C1 – C4, hence reading on the invention as claimed);
dispensing a blood sample into the first chamber via a probe to produce a sample mixture (see page 11, lines 12 – 21 describing the needle 6 used to collect blood from a tube of whole blood 10, then the needle 6 is moved into the first chamber 2 to inject all of the collected blood into the chamber 2, see arrangement and fluid flow path at Fig. 3, see page 11, lines 20 – 26 describing injection of the blood into chamber 2 is continued so as to fill up with the dilution reagent contained in the first liquid pathway C1, thus forming mixture of the blood and the dilution reagent); and
conveying a portion of the sample mixture from the first chamber (2) to a second chamber (7) via the first pump (see arrangement and fluid flow path at Fig. 5, see page 11, line 33 – page 12, lines 1 – 8, describing the portion of the sample mixture conveyed to a second chamber 7 through the channel 8, see “aspiration system” described at page 8, lines 6 – 9, and/or see “precision pistons/syringes” described at page 6, lines 17 – 22 and/or see element 4, “Dispenser of dilution reagent”, Figs. 1 – 5 which aid in dispensing, aspirating, conveying the fluid sample and mixture through the respective conduits C1 – C4, hence reading on the invention as claimed).
Insofar as Baston may be construed as not explicitly stating a “pump”, Baston does teach “an aspiration system”, “precision pistons/syringes” (which is not illustrated in the figures but described at page 8, lines 6 – 9 and page 6, lines 17 – 22, respectively) as well as element 4 “Dispenser of dilution reagent” in Figs. 1 – 5 which aid in conveying, aspirating and dispensing of the fluid through the respective conduits C1 – C4 as described above.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to recognize a pump as the aspiration system or pistons/syringes or 4, Fig.1 of Baston, since it is known in the art that aspiration systems are designed to generate vacuum or negative pressure and may be designed to use pumps in order to draw a desired amount of fluid.
In addition, Lawrence, in the field of devices, systems and methods for medical diagnostic analysis of a sample, teaches that it is known to use a pump configured to convey and aspirate in the system (see paragraph [0008] describing use of a sample pump configured to perform a first plurality of tasks including, aspirating sample into the sample probe, dispensing sample from the sample probe into the first mixing chamber, dispensing sample from the sample probe into a second mixing chamber, delivering first sample-dilution fluid mixture to a flow cell, and delivering second sample-dilution fluid mixture to the flow cell, see also Fig. 6 illustrating sample pump 210, see additional pumps 220 – 240, 400, see paragraphs [0081], [0083], [0090] – [0091]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use pump system of Lawrence into Baston, in order to allow precise and consistent aspiration, dispensing and conveying of samples into and out of the system.
Baston in view of Lawrence as modified above teaches wherein the first and second chambers are configured to be selectively fluidly coupled to each other (see arrangement at Fig. 1 of Baston which illustrates chambers 2 and 7 being selectively fluidly coupled via valve 5, note that the operation of the device as seen at Fig. 1 allows chambers 2 and 7 to be selectively fluidly coupled as claimed, see steps at page 11, line 20 – page 12 line 8 and Figs. 1 – 5, hence reading on the invention as claimed).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. However, an updated search will again be made upon applicant’s response.
Regarding Claim 10, the prior art of records do not explicitly teach “comprising at least one diluent push/pull line configured to be selectively fluidly coupled to the transfer line, wherein the pump is configured to, when the at least one diluent push/pull line is fluidly coupled to the transfer line, draw an air gap into the at least one diluent push/pull line while aspirating the portion of the sample mixture into the transfer line, wherein the air gap serves as a protective barrier between a diluent and the portion of the sample mixture” (as seen at fig. 4 of the instant application) in combination with the remaining limitations of the base claim and the intervening claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form accompanying this office action which includes the following relevant prior arts:
Eherts Robert W. et al. (CA 2274887 C) teaches sample dilution module with offset mixing chamber. The device further aspirates a micro-bubble between separate aspirations of test sample and diluent to prevent contact between the sample and diluent in the aspiration probe.
THIS ACTION IS MADE FINAL. 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 MARRIT EYASSU whose telephone number is (571)270-1403. The examiner can normally be reached M - F: 9:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Laura E. Martin can be reached at (571) 272-2160. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARRIT EYASSU/Primary Examiner, Art Unit 2855
