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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07 August 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because of the following:
Figures 1 and 2: Blank reference boxes “30” and “70” should also be labeled with their representative structure in order to more easily identify the structure quickly that is utilized in the invention without having to read through the specification.
For example, reference box (70), as shown in Figures 1 and 2, should also be labeled – Control Device --. See 37 C.F.R. 1.83(a) below.
1.83 Content of drawing.
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(a) The drawing in a nonprovisional application must show every feature of the invention specified in the claims. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box). In addition, tables that are included in the specification and sequences that are included in sequence listings should not be duplicated in the drawings.
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(b) When the invention consists of an improvement on an old machine the drawing must when possible exhibit, in one or more views, the improved portion itself, disconnected from the old structure, and also in another view, so much only of the old structure as will suffice to show the connection of the invention therewith.
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(c) Where the drawings in a nonprovisional application do not comply with the requirements of paragraphs (a) and (b) of this section, the examiner shall require such additional illustration within a time period of not less than two months from the date of the sending of a notice thereof. Such corrections are subject to the requirements of § 1.81(d).
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[31 FR 12923, Oct. 4, 1966; 43 FR 4015, Jan. 31, 1978; paras. (a) and (c) revised, 60 FR 20195, Apr. 25, 1995, effective June 8, 1995; para. (a) revised, 69 FR 56481, Sept. 21, 2004, effective Oct. 21, 2004; para. (a) revised, 78 FR 62368, Oct. 21, 2013, effective Dec. 18, 2013]
PLEASE NOTE THAT A REFERENCE NUMERAL IS NOT A LABEL.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “120” has been used to designate both a “fluid conveying device” (top of Figure 1) and a “fractionator” (bottom right of Figure 1). Do these two “sample handling devices” contain the same structure or operate the same? If not, then the two devices should have different reference numerals.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Paragraph [0015], line 3: A – comma – should be inserted after the term “example” as that which follows the term is a list, example or explanation that is essential to the meaning.
Paragraph [0016], line 5: A – comma – should be inserted after both instances of the abbreviation “e.g.” as the specification should conform to American English, which uses a comma after the abbreviation.
Paragraph [0018], lines 3 and 4: A – comma – should be inserted after the abbreviation “e.g.”
Paragraph [0027], line 10: A – comma – should be inserted after the abbreviation “i.e.” when writing in standard American English when the abbreviation is a part of the main sentence, not enclosed in parentheses.
Paragraph [0028], line 4: A – comma – should be inserted after the abbreviation “i.e.”
Paragraph [0032], line 6: A – comma – should be inserted after the abbreviation “e.g.”
Paragraph [0035], line 16: A – comma – should be inserted after the term “example”.
Paragraph [0036], line 8: A – comma – should be inserted after the term “example”.
Paragraph [0041], line 11: A – comma – should be inserted after the term “example”.
Paragraph [0044], lines 2 and 6: A – comma – should be inserted after the term “example”.
Paragraph [0049], line 3: A – comma – should be inserted after the term “example”.
Paragraph [0053], line 2: A – comma – should be inserted after the term “example”.
Paragraph [0074], line 2: A – comma – should be inserted after the term “example”.
Paragraph [0085], lines 6 and 8: A – comma – should be inserted after the term “example”.
Paragraph [0098], line 12: A – comma – should be inserted after the term “example”.
Paragraph [0102], line 8: Reference numeral – 180 – should replace reference numeral “190”.
Paragraph [0102], line 12: A – comma – should be inserted after the term “example”.
Paragraph [0103], line 8: A – comma – should be inserted after the term “example”.
Appropriate correction is required.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Re claim 1, claim line : The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the device.
Re claim 1, claim line 2: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the analyzer.
Re claim 1, claim line 4: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the lumen.
Re claim 1, claim line 2: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the analyzer.
Re claim 6, claim line 2: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the bearing.
Re claim 10, claim line 2: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the fitting.
Re claim 13, claim line 5: Some conjunction – or -- should be inserted after the semicolon as this claim is listing one of two choices rather than at least one of the two choices.
Re claim 13, claim line 7: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the fractionator.
Re claim 17, claim line 1: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the analyzer.
Re claim 17, claim line 3: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the device.
Re claim 19, claim line 5: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the separation device.
Re claim 19, claim line 14: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the detector.
Re claim 19, claim lie 15: The conjunction – and – should be inserted after the semicolon as this limitation/example is the penultimate example from the list of examples/limitations.
Re claim 19, claim line 16: The term – configured – should be inserted prior to the term “for” to positively recite the functionality/intended use of the fractionator.
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 7, 12, and 18-19 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.
Re claim 7, claim line 7: The term “in particular” is deemed to be indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Re claim 12, claim line 2: The term “rigidly” is a relative term which renders the claim indefinite. The term “rigidly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much play is allowed in the connection between the needle housing and the moving apparatus while still being deemed to be rigidly attached.
Re claim 18, claim line 4: The phrase “the mobile phase” lacks antecedent basis.
Re claim 19, claim line 11: The phrase “the mobile phase” lacks antecedent basis.
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 1-2, 8-11, 15-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0093426 (Hirano et al.) in view of US 2004/0220472 (Harui et al.).
With respect to the limitations of claim 1, Hirano et al. disclose a sample handling device (Figure 2 and paragraphs [0053-0054]) for handling a fluidic sample in an analyzer for analyzing the fluidic sample (Figure 1 and paragraph [0050]), the sample handling device comprising:
a sample needle/dispensing probe (124) comprising a lumen for passing through the fluidic sample (dispensing probe (124) is hollow comprising a lumen that allows fluid to pass through - paragraph [0054], lines 7-8 and Figure 2); and
a moving apparatus (121, 122, 123) configured to move the sample needle (124) by a rotational movement (arms (122, 123) move dispensing probe (124) around the shaft (121) in a rotational manner - paragraph [0053], lines 3-10),
wherein the sample needle is rotatably mounted relative to the moving apparatus (sample needle (124) attached to rotatable arm (123) is also rotatably mounted relative to the moving apparatus (121, 122) – Figure 2). Hirano et al. fail to expressly disclose that the sample needle is rotatable about its own axis.
Harui et al. disclose a rotating fluidic pump comprising a motor configured to rotate the syringe about its own axis, independent of the motion of the lead screw (abstract). Modifying Hirano et al. to utilize a sample needle rotatable about its own axis would have been obvious to one of ordinary skill in the art at the time of filing as a means of providing a uniformly distributed sample.
With respect to the limitation of claim 2, the combination (Hirano et al.) further disclose that the sample needle (124) is connected and fluidically coupled to a sample receiving volume (132), and wherein the rotatable mounting of the sample needle (124) relative to the moving apparatus (121, 122) is configured such that a relative movement between the sample needle (124) and the sample receiving volume is reduced (Figure 2 and paragraph [0054] – sample needle/dispensing probe (124) is connected and fluidically coupled to a syringe (125) used to provide fluid through a tube (126) located within the moving apparatus (121, 122) and to the dispensing probe (124)).
With respect to the limitation of claim 8, the combination (Hirano et al.) further discloses a sample receiving volume comprises a metallic capillary (a syringe (125) and tube (126) are utilized as a sample receiving volume and it well within the purview of one of ordinary skill in the art to manufacture tubing from metal (paragraphs [0053-0054] and Figure 2) as a means of providing a long lasting durable material that is non-reactive to fluids being dispensed).
With respect to the limitation of claim 9, the combination (Hirano et al.) further discloses that the sample receiving volume comprises a sample loop (tube (126) located within the shaft (121) and arms (122,123) act as a sample loop – paragraph [0054] and Figure 2).
With respect to the limitation of claim 10, the combination (Hirano et al.) further discloses a fitting for fluidically couple the sample needle to the sample receiving volume (some means/fitting is used to fluidically couple the dispensing probe/needle (124) to the tube (126) and syringe acting as the sample receiving volume – paragraph [0054] and Figure 2).
With respect to the limitation of claim 11, the combination (Hirano et al.) appears to further disclose that the sample needle (124) has no further degree of freedom of movement relative to the moving apparatus (122, 123) in addition to its rotatability about its own axis (paragraphs [0053-0054] and Figure 2).
With respect to the limitation of claim 14, the combination (Hirano et al.) further disclose a fluid conveying means/plunger (127) adapted to draw the fluidic sample from a sample receiving device/syringe (125) through the sample needle (124) into a sample receiving volume (126) of the needle arrangement.
With respect to the limitation of claim 15, the combination (Hirano et al.) further appears to disclose that the moving apparatus (121, 122, 123) comprises at least one of a group consisting of:
a cantilever arm (123) for rotating the sample needle (124) (arm (123) is comprised of a cantilever for rotating the dispensing probe (124) – paragraphs [0053-0054] and Figure 2),
a linear moving apparatus for moving the sample needle (126) linearly along a linear direction (shaft (121) of the moving apparatus is capable of moving the dispensing probe (124) in a linear direction, i.e. up and down – paragraph [0053], lines 3-5 and Figure 2),
a two-dimensional moving apparatus for moving the sample needle (124) in two spatial dimensions (dispensing probe (124) is attached to a free end of arm (123), which has a second end attached to the free end of arm (122), which is movable in the X-Y plane – paragraph [0053], lines 5-10 and Figure 2), and
a three-dimensional moving apparatus for moving the sample needle (126) in three spatial dimensions.
With respect to the limitation of claim 16, the combination (Hirano et al.) further discloses a needle seat into which the sample needle (124) is insertable in a fluid-tight manner by moving the moving apparatus (121, 122, 123) to guide fluidic sample through the sample needle (124) and through the needle seat (some means is utilized to provide a leak-free attachment of the dispensing probe (124) into the arm (123), which allows the moving apparatus to guide fluidic sample through the dispenser probe (124) and through the attachment means – Figure 2).
With respect to the limitation of claim 17, the combination (Hirano et al.) disclose an analyzer (automatic analytical device - Figure 1 and paragraph [0050]), comprising at least one sample handling device (Figure 2 and paragraphs [0053-0054]) according to claim 1 for handling the fluidic sample.
With respect to the limitations of claim 20, Hirano et al. disclose a method operating an analyzer, comprising:
passing fluidic sample through a lumen of a sample needle (124) for transferring the fluidic sample between a sample receiving device and a sample receiving volume fluidically coupled to the sample needle (126) (dispensing probe (124) is hollow comprising a lumen that allows fluid to pass through from a fluid supply and to dispense the fluid into a fluid receiving volume - paragraph [0054], lines 7-8 and Figures 1-2);
rotationally moving the sample needle (124) by means of a moving apparatus (121, 122, 123) (arms (122, 123) move dispensing probe (124) around the shaft (121) in a rotational manner - paragraph [0053], lines 3-10); and
rotating the sample needle (124) relative to the moving apparatus (121, 122, 123) (sample needle (124) attached to rotatable arm (123) is also rotatably mounted relative to the moving apparatus (121, 122) – Figure 2),
wherein the sample needle (124) is rotatably mounted relative to the moving apparatus (sample needle (124) attached to rotatable arm (123) is also rotatably mounted relative to the moving apparatus (121, 122) – Figure 2). Hirano et al. fail to expressly disclose that the sample needle is rotatable about its own axis.
Harui et al. disclose a rotating fluidic pump comprising a motor configured to rotate the syringe about its own axis, independent of the motion of the lead screw (abstract). Modifying Hirano et al. to utilize a sample needle rotatable about its own axis would have been obvious to one of ordinary skill in the art at the time of filing as a means of providing a uniformly distributed sample.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0093426 (Hirano et al.) in view of US 2004/0220472 (Harui et al.) as applied to claim 1 above, and further in view of US 2006/0254370 (Wicky).
With respect to the limitations of claims 6 and 7, the combination discloses all of the limitations of the base claim, but, fails to disclose a rotation bearing for rotatably bearing the sample needle.
Wicky discloses a method for placing a receptacle in a device for sampling liquid comprising a pivoting support (6) that acts as a bearing for rotating a sample needle (4), whereby the rotation bearing (6) appears to be arranged between and sample needle (4) and a needle housing in which part of the sample needle is mounted (needle is attached to some means for housing the needle – Figure 4-8 and paragraphs [0042-0043]). Modifying the combination to utilize a rotation bearing would have been obvious to one of ordinary skill in the art at the time of filing the invention as a means of securing the needle to a fixture while also allowing rotation of the needle.
Claims 13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0093426 (Hirano et al.) in view of US 2004/0220472 (Harui et al.) as applied to claim1 and 17 above, and further in view of US 2016/0245730 (Neal).
With respect to the limitations of claim 13, the combination discloses all of the limitations of the base claim, but, fails to disclose that the sample handling device is configured as an injector for injecting the fluidic sample to be analyzed from an injector path of the sample handling device into a separation path of the analyzer; wherein the sample handling device is configured as a fractionator for fractionating the analyzed, in particular separated, fluidic sample.
Neal disclose an autosampler and gas chromatography system comprising a sample handling device configured as an injector (28A) for injecting a fluidic sample to be analyzed (40A) from an injector path of the sample handling device into a separation path (column 30) of the analyzer (40A). Modifying the combination to utilize an injector and a separation path would have been obvious to one of ordinary skill in the art at the time of filing the invention as a means of ensuring the sample is introduced to the separation path at the appropriate flow path to ensure separation of the sample into detectable components.
With respect to the limitation of claim 18, the combination discloses all of the limitations of the base claim, but fails to disclose a sample separation device, wherein the sample handling device is configured as an injector for injecting the fluidic sample into the mobile phase; and wherein the analyzer comprises a fluid drive for driving the mobile phase and the fluidic sample injected into the mobile phase and a sample separation device for separating the fluidic sample injected into the mobile phase.
Neal disclose an autosampler and gas chromatography system comprising a sample handling device configured as an injector (28A) for injecting a fluidic sample to be analyzed (40A) from an injector path of the sample handling device into a separation path (column 30) of the analyzer (40A) (Figure 1). Modifying the combination to utilize an injector and a separation path would have been obvious to one of ordinary skill in the art at the time of filing the invention as a means of ensuring the sample is introduced to the separation path at the appropriate flow path to ensure separation of the sample into detectable components.
With respect to the limitation of claim 19, the combination discloses all of the limitations of the base claim, but fails to disclose at least one of the following features:
the analyzer is configured to analyze at least one physical, chemical and/or biological parameter of the fluidic sample;
the analyzer is configured as a sample separation device for separating the fluidic sample;
the analyzer is configured as a chromatography device;
the analyzer is configured as a microfluidic device;
the analyzer is configured as a nanofluidic device;
the sample separation device is configured as a chromatographic separation device;
the fluid drive is configured to drive the mobile phase and the fluidic sample with a pressure selected from the group consisting of at least 500 bar; at least 1000 bar; and at least 1200 bar;
the analyzer comprises a detector for detecting the analyzed fluidic sample; and
the analyzer comprises a fractionator for fractionating separate fractions of the fluidic sample.
Neal disclose an autosampler and gas chromatography system comprising a sample handling device configured as an injector (28A) for injecting a fluidic sample to be analyzed (40A) from an injector path of the sample handling device into a separation path (column 30) of the analyzer (40A) (Figure 1), whereby the analyzer is configured to analyze at least one physical, chemical and/or biological parameter of the fluidic sample; and the sample separation device is configured as a chromatographic separation device. Modifying the combination to utilize an injector and a separation path would have been obvious to one of ordinary skill in the art at the time of filing the invention as a means of ensuring the sample is introduced to the separation path at the appropriate flow path to ensure separation of the sample into detectable components.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Prior art was not relied upon to reject claims 3-5 and 12 because the prior art of record fails to teach and/or make obvious a needle housing (192) in which a part of the sample needle (126) is mounted in such a way that when the sample needle (126) rotates about its own axis, the needle housing (192) remains stationary in a rotationally fixed manner in combination with all of the limitations of the base claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art disclose sampling needles capable of rotating around their own axis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL SEAN LARKIN whose telephone number is 571-272-2198. The examiner can normally be reached M-F 9:00 AM - 5:30 PM.
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, Laura Sweeney 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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/DANIEL S LARKIN/Primary Examiner, Art Unit 2855
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