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 .
Drawings
The drawings are objected to because Fig. 1-3 are duplicated. 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.
Claim Objections
Claim 8 objected to because of the following informalities:
Claim 8, line 1 recites the limitation “as claimed in elaim 1” which includes a typographical error and should read “as claimed in claim 1”
Appropriate correction is required.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boitard et al. (US 2021/0332317 A1) in view of Papkovsky et al. (US 2013/0280751 A1) further in view of Goodwin et al. (US 6788409 B2).
Regarding claim 1, Boitard discloses a method for measuring solubilization of particles by at least one living cell and/or at least one derived product of a living cell, the method comprising the following steps:
- supplying a stable suspension ([0086]; [0120]),
- generating at least one drop (42) comprising a culture medium (50) that may contain at least one living cell (4) and/or at least one derived product of a living cell (oxygen indicator/reducing agent) in suspension (Fig. 2; [0012]; [0035]-[0036] [0071]-[0072]),
- introducing the drop into a tube (10) (Fig. 2; [0013]; [0056]-[0057]),
- incubating the drop in the tube ([0014]; [0056]),
- illuminating the tube with an incident light beam ([0015]; [0108]-[0113] – where illumination light is implied in optical measurement systems implementing optical density and/or fluorescence measurement methods), and
- measuring, at different time points, the quantity of light of the light beam scattered to the incident beam by the drop in the tube ([0015]; [0021]; [0108]-[0113]).
Boitard discloses a suspension of cells in a controlled atmosphere (6) which may include other reagents ([0086]-[0087]) but does not explicitly disclose supplying particles to be solubilized in stable suspension, the particles of a suspension being of identical chemical composition,
generating at least one drop comprising at least one particle to be solubilized of the stable suspension of particles and a culture medium that may contain at least one living cell and/or at least one derived product of a living cell in suspension,
measuring, at different time points, the quantity of light of the light beam scattered transversely to the incident beam by the drop in the tube.
However, Papkovsky, in the same field of endeavor of methods and systems for analyzing cell culture systems, discloses
supplying particles to be solubilized in a stable suspension, the particles of a suspension being of identical chemical composition (Abstract; Claim 1, lines 12-23).),
generating at least one drop comprising at least one particle to be solubilized of the stable suspension of particles and a culture medium that may contain at least one living cell and/or at least one derived product of a living cell in suspension (Abstract; Claim 1, lines 12-23).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Boitard with a method step which introduces at least one particle to be solubilized where the motivation would be to monitor individual cell health or function, utilizing a probe that has no intrinsic toxicity to cells and allow for a more accurate assessment of conditions in the suspension (Papkovsky: [0028]).
Boitard in view of Papkovsky does not explicitly disclose measuring, at different time points, the quantity of light of the light beam scattered transversely to the incident beam by the drop in the tube.
However, Goodwin, in the same field of endeavor of methods and systems for analyzing cell culture systems, discloses measuring, at different time points, a quantity of light of a light beam scattered transversely to an incident beam by a drop in a tube (Col. 6, lines 49-62 – where transverse scattering is interpreted as implying side-scattering at 90 degrees to the incident beam).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Boitard in view of Papkovsly with a measurement system for detecting 90 degree or transversely scattered light which optimizes the signal to noise and increases overall sensitivity (Goodwin: Col. 6, lines 49-54),
Regarding claim 2, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, and further discloses comparison of the values obtained at the different time points for each drop, and at the end of this comparison, determining the presence or absence, in the drop, of living cells and/or of the derived products thereof capable of solubilizing the particle (Boitard: [0108]-[0113] – where quantifying measurements of cell growth, cell death or measurements of oxygen levels by detecting an oxygen indicator agent over different times inherently involves a dynamic comparison of values).
Regarding claim 3, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, and further discloses a step of measuring the quantity of living cells and/or of the derived products thereof present in the drop at the different time points (Boitard: [0108]-[0113]).
Regarding claim 4, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, and further discloses in which the particles of the stable suspension are in suspension in an aqueous solution comprising at least one substance for stabilizing the suspension of particles (Boitard: [0118]-[0121]).
Regarding claim 5, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, and further discloses a measurement system in which the tube has an inside diameter between 0.1 mm and 3 mm (Boitard: [0057]).
Regarding claim 6, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, but does not disclose a suspension in which at least 90% of the particles in the stable suspension have a radius between 10 nm and 10 μm, preferably between 100 nm and 500 nm.
However, Papkovsky further discloses a suspension in which at least 90% of the particles in the stable suspension have a radius between 10 nm and 10 μm, preferably between 100 nm and 500 nm (Abstract, lines 3-5; [0014]; [0053]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Boitard in view of Papkovsky and Goodwin with a method step which introduces a suspension of particles to be solubilized of a certain size that is smaller than the cells, allowing for efficient monitoring of individual cell health or function while also utilizing a probe that has no intrinsic toxicity to cells, providing a more accurate assessment of conditions in the suspension (Papkovsky: [0028]; [0053]).
Regarding claim 7, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, and further discloses in which at least one drop contains at least one particle to be solubilized of the stable suspension of particles and a culture medium containing at least one living cell and/or at least one derived product of a living cell in suspension (Papkovsky: Abstract; claim 1, lines 12-23).
Regarding claim 8, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 1, as outlined above, and further discloses generating a train of ordered drops in a carrying fluid, the train of drops (Boitard: [0012]; [0065]-[0071]) comprising at least one drop comprising at least one particle to be solubilized in stable suspension and a culture medium that may contain at least one living cell and/or at least one derived product of a living cell in suspension (Papkovsky: Abstract; claim 1, lines 12-23).
Regarding claim 9, Boitard in view of Papkovsky and Goodwin discloses the method of measurement as claimed in claim 3, as outlined above, and further discloses a method in which the step of measuring the quantity of living cells and/or of the derived products thereof present in the drop at the different time points comprises measurement of a fluorescence signal associated with respiration or with alteration of the pH of the medium by the living cells and/or the derived products thereof present in the drop (Boitard: [0108]-[0113]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER YAZBACK whose telephone number is (703)756-1456. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/MAHER YAZBACK/Examiner, Art Unit 2877
/MICHELLE M IACOLETTI/Supervisory Patent Examiner, Art Unit 2877
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