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 .
The Preliminary Amendment filed on 04/15/2024 has been acknowledged.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: A HANDS-FREE SAMPLE INSERTION APPARATUS FOR USE IN A DIAGNOSTIC ANALYZER AND A METHOD THEREOF.
Claim Objections
Claim 10 is objected to because of the following informalities: In line 2 of claim 10, the limitation is grammatically incorrect by stating “...wherein the a transmission assembly…” The limitation will be read as “…wherein the transmission assembly comprises…” upon further examination. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 12-15 & 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruther et al (US 20030180193 A1) “hereinafter Ruther”.
In regards to claim 1, Ruther teaches a sample insertion apparatus (1, i.e. sample entry device) comprising an insertion head (8, i.e. elastic intake element) having a coupler (9, i.e. intake opening) configured to couple to a sample container (11, i.e. syringe) having an insertion member (20, i.e. cone) (Paragraph 0026; Figures 1 & 2); an arm (5, i.e. sample tube) containing a sample probe (3, i.e. needle) positioned stationary relative to the arm (5); and a retraction assembly (wherein the retraction assembly includes an actuating element (13), drive unit (12) and coupling element (7) (Paragraph 0026) coupled to the insertion head (8) and configured to cause the sample container (11) to move towards the sample probe (3) to insert the sample probe (3) into the insertion member (20) (Paragraph 0027; Figures 3 & 4).
In regards to claim 2, Ruther teaches wherein the sample container (11) is a syringe (Paragraph 0026).
In regards to claim 3, Ruther teaches wherein the insertion member (20) comprises a penetrable membrane (i.e. penetration into the interior of the syringe (11) as seen in Figures 3 & 4) of the syringe (11) (Paragraph 0031).
In regards to claim 4, Ruther teaches wherein the retraction assembly comprises: a guide assembly (16, i.e. holding element), and a drive assembly (18, i.e. drive unit) (Paragraph 0027).
In regards to claim 12, Ruther teaches a sample insertion method comprising: providing an insertion head (8, i.e. elastic intake element) of a sample insertion apparatus (1, i.e. sample entry device) in an extended position (Paragraph 0026; Figures 1 & 2); providing an arm (5, i.e. sample tube) proximate to the insertion head (8), the arm (5) including a sample probe (3, i.e. needle) (Paragraph 0026); coupling a sample container (11, i.e. syringe) to the insertion head (8), the sample container (11) including an insertion member (20, i.e. cone) (Paragraph 0026; Figures 1 & 2); and retracting from the extended position (wherein the retraction assembly retracts by using an actuating element (13), drive unit (12) and coupling element (7) (Paragraph 0026), with the aid of a guide assembly (16, i.e. holding unit) and a drive assembly (18, i.e. drive unit) (Paragraph 0027), the insertion head (8) towards the arm and the sample probe (3) to cause insertion of the insertion member (20) of the sample container (11) over the sample probe (3) (Paragraph 0027; Figures 3 & 4).
In regards to claim 13, Ruther teaches where the coupling of the sample container (11) to the insertion head (8) comprises first coupling the insertion head (8) to an insertion head receiver (17, i.e. conical opening) (Paragraph 0027).
In regards to claim 14, Ruther teaches wherein the guide assembly (16) guides the insertion head (8) in a linear path (i.e. axially slidable) when undergoing the retracting from the extended position (Paragraphs 0015 & 0027).
In regards to claim 15, Ruther teaches wherein the retracting from the extended position comprises driving a drive bracket (22, i.e. fittings) of the guide assembly (16) with the drive assembly (18) (Paragraphs 0015, 0027 & 0032).
In regards to claim 17, Ruther teaches the method step of drawing in the sample following the insertion of the sample probe (3) into the insertion member of the sample container (11) (Paragraphs 0015 & 0027; Figures 3 & 4).
In regards to claim 18, Ruther teaches the method step of after the drawing in of the sample, returning the insertion head (8) to the extended position (Paragraphs 0015 & 0027).
In regards to claim 19, Ruther teaches wherein during the retracting from the extended position the sample probe (3) is stationary (Paragraphs 0015 & 0031).
In regards to claim 20, Ruther teaches wherein the coupling of a sample container (11) to the insertion head (8) comprises coupling a syringe (11) to the insertion head (8), and the insertion member (20) comprises a port or a penetrable membrane (i.e. penetration into the interior of the syringe (11) as seen in Figures 3 & 4; Paragraph 0031).
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.
Claims 8, 9 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ruther et al (US 20030180193 A1) “hereinafter Ruther” in view of Londo et al (US 8057756 B2) “hereinafter Londo”.
In regards to claim 8, Ruther teaches the claimed invention except for wherein the drive assembly comprises a mounting bracket coupleable to a body of the sample insertion apparatus, a drive motor coupled to the mounting bracket; a lead screw, and a transmission assembly coupled to the drive motor and the lead screw.
Londo teaches a self-contained sampling probe further comprising a drive assembly (113, i.e. drive motor assembly) comprises a mounting bracket (118 & 119, i.e. slot member) coupleable to a body of the sample insertion apparatus (72, i.e. syringe module), a drive motor (i.e. electric motor) coupled to the mounting bracket (118 & 119); a lead screw (115), and a transmission assembly coupled to the drive motor (i.e. electric motor) and the lead screw (115) (Column 11, lines 36-57; Figures 3 & 5).
It would have been obvious to one having skill in the art before the effective filing date of the invention being made to provide a drive assembly unit as taught by Londo into the sample insertion apparatus of Ruther for the purpose of guiding the linear axial movement of the guide passage (Column 11, lines 48-50; Londo).
In regards to claim 9, Ruther teaches the claimed invention except for wherein the lead screw engages with a lead nut coupled to a drive bracket.
Londo teaches a self-contained sampling probe further comprising a drive assembly (113, i.e. drive motor assembly) further comprising the lead screw (115) engaging with a lead nut (110) coupled to a drive bracket (Column 11, lines 36-57; Figures 3 & 5).
It would have been obvious to one having skill in the art before the effective filing date of the invention being made to provide a drive assembly unit as taught by Londo into the sample insertion apparatus of Ruther for the purpose of guiding the linear axial movement of the guide passage (Column 11, lines 48-50; Londo).
In regards to claim 16, Ruther teaches the claimed invention except for wherein the driving the drive bracket comprises driving a transmission assembly coupled to a drive motor, which in turn causes rotation of a lead screw coupled to a lead nut attached to the drive bracket.
Londo teaches a self-contained sampling probe further comprising a drive assembly (113, i.e. drive motor assembly) further comprising the lead screw (115) engaging with a lead nut (110) coupled to a drive bracket (Column 11, lines 36-57; Figures 3 & 5).
It would have been obvious to one having skill in the art before the effective filing date of the invention being made to provide a drive assembly unit as taught by Londo into the sample insertion apparatus of Ruther for the purpose of guiding the linear axial movement of the guide passage (Column 11, lines 48-50; Londo).
Allowable Subject Matter
Claims 11, 21 & 22 are allowed.
Claims 5-7 & 10 are 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.
The following is a statement of reasons for the indication of allowable subject matter: In the Examiner’s opinion in regards to claim 5, Ruther teaches a sample insertion apparatus (1, i.e. sample entry device) comprising an insertion head (8, i.e. elastic intake element) having a coupler (9, i.e. intake opening) configured to couple to a sample container (11, i.e. syringe) having an insertion member (20, i.e. cone) (Paragraph 0026; Figures 1 & 2); an arm (5, i.e. sample tube) containing a sample probe (3, i.e. needle) positioned stationary relative to the arm (5); and a retraction assembly (wherein the retraction assembly includes an actuating element (13), drive unit (12) and coupling element (7) (Paragraph 0026) coupled to the insertion head (8) and configured to cause the sample container (11) to move towards the sample probe (3) to insert the sample probe (3) into the insertion member (20) (Paragraph 0027; Figures 3 & 4).
However, Ruther does not teach the structural limitations and combination of the sample insertion apparatus further comprising the guide assembly including a guide member coupled to a body of the sample insertion apparatus, a guide rod assembly including one or more guide rods moveable in the guide member, an insertion head receiver attached to the one or more guide rods wherein the insertion head is coupled to the insertion head receiver, and a drive bracket secured to the one or more guide rods where the stated limitations are not suggested in addition to not being anticipated or taught in combination with the remaining limitations of independent claim 1 upon overcoming the rejection under 35 U.S.C. 102(a)(1). The remaining claims are allowed due to their dependency.
In the Examiner’s opinion in regards to claim 10, Ruther teaches a sample insertion apparatus (1, i.e. sample entry device) comprising an insertion head (8, i.e. elastic intake element) having a coupler (9, i.e. intake opening) configured to couple to a sample container (11, i.e. syringe) having an insertion member (20, i.e. cone) (Paragraph 0026; Figures 1 & 2); an arm (5, i.e. sample tube) containing a sample probe (3, i.e. needle) positioned stationary relative to the arm (5); and a retraction assembly (wherein the retraction assembly includes an actuating element (13), drive unit (12) and coupling element (7) (Paragraph 0026) coupled to the insertion head (8) and configured to cause the sample container (11) to move towards the sample probe (3) to insert the sample probe (3) into the insertion member (20) (Paragraph 0027; Figures 3 & 4).
However, Ruther does not teach the structural limitations and combination of the sample insertion apparatus further comprising the transmission assembly including a first pulley coupled to the drive motor, a second pulley coupled to the lead screw, and a belt engaging the first pulley and the second pulley where the stated limitations are not suggested in addition to not being anticipated or taught in combination with the remaining limitations of independent claim 1 upon overcoming the rejection under 35 U.S.C. 103.
In the Examiner’s opinion in regards to claim 11, Ruther teaches a sample insertion apparatus (1, i.e. sample entry device) comprising an insertion head (8, i.e. elastic intake element) having a coupler (9, i.e. intake opening) configured to couple to a sample container (11, i.e. syringe) having an insertion member (20, i.e. cone) (Paragraph 0026; Figures 1 & 2); an arm (5, i.e. sample tube) containing a sample probe (3, i.e. needle) positioned stationary relative to the arm (5); and a retraction assembly (wherein the retraction assembly includes an actuating element (13), drive unit (12) and coupling element (7) (Paragraph 0026) coupled to the insertion head (8) and configured to cause the sample container (11) to move towards the sample probe (3) to insert the sample probe (3) into the insertion member (20) (Paragraph 0027; Figures 3 & 4).
However, Ruther does not teach the structural limitations and combination of the sample insertion apparatus further comprising the retraction assembly including a guide assembly having a guide member coupled to a body of the sample insertion apparatus wherein a guide rod assembly includes one or more guide rods moveable in the guide member, an insertion head receiver attached to the one or more guide rods, a moveable insertion head coupled to the insertion head receiver, and a drive bracket secured to the one or more guide rods where the stated limitations are not suggested in addition to not being anticipated or taught in combination with the remaining limitations of independent claim 11.
In the Examiner’s opinion in regards to claim 21, Ruther teaches a sample insertion apparatus (1, i.e. sample entry device) comprising an insertion head (8, i.e. elastic intake element) having a coupler (9, i.e. intake opening) configured to couple to a sample container (11, i.e. syringe) having an insertion member (20, i.e. cone) (Paragraph 0026; Figures 1 & 2); an arm (5, i.e. sample tube) containing a sample probe (3, i.e. needle) positioned stationary relative to the arm (5); and a retraction assembly (wherein the retraction assembly includes an actuating element (13), drive unit (12) and coupling element (7) (Paragraph 0026) coupled to the insertion head (8) and configured to cause the sample container (11) to move towards the sample probe (3) to insert the sample probe (3) into the insertion member (20) (Paragraph 0027; Figures 3 & 4).
However, Ruther does not teach the method of operating a diagnostic analyzer including a sample insertion apparatus further comprising the method steps of hands-free retracting at least a portion of the sample container within the apparatus housing to insert a sample probe into the sample container wherein the sample probe is being contained entirely within the apparatus housing at all times where the stated limitations are not suggested in addition to not being anticipated or taught in combination with the remaining limitations of independent claim 21. The remaining claim is allowed due to its dependency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERMAINE L JENKINS whose telephone number is (571)272-2179. The examiner can normally be reached M-F 7-3 EST.
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/J.L.J/Examiner, Art Unit 2855
/PETER J MACCHIAROLO/Supervisory Patent Examiner, Art Unit 2855
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