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 .
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 15-19 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.
Claim 15 recites “A measuring method of measuring the physical property data using the flow cell according to claim 1.” However, the claim does not recite any active positive steps delimiting how the use is actually practices. See Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). MPEP 2173.05(q). A process without setting forth any steps involved is indefinite under 35 USC 112(b). Note that no rejection is made under 35 USC 101 as the claim recites a method, which is one of the statutory classes under 35 U.S.C. 101.
Claims 16-19 are rejected based on their dependency on claim 1. The dependent claims do not add any further steps, only defining the sample via a wherein clause.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 8, 10-13, and 15 are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Dixon et al. (US 2018/0313743 A1), hereinafter “Dixon”.
Regarding claim 1, Dixon discloses a flow cell (abstract, Figs. 1, 2) comprising:
a main body that includes a flow passage (ref 102, paragraph [0060]) through which fluid containing a substance (paragraph [0092]) from which physical property data is to be measured flows (paragraphs [0037]-[0040]), and contains a resin (paragraphs [0044], [0046]); and
an optical system which is disposed on a part of a wall surface forming the flow passage and condenses measurement light for the physical property data (paragraphs [0038], [0047], [0058], [0061]) and of which an emission surface for the measurement light is in contact with the fluid flowing through the flow passage (paragraph [0059]),
wherein at least a part of an opposite wall surface that is the wall surface facing the optical system and at least a part of a side wall surface that is the wall surface interposed between the opposite wall surface and the optical system are covered with a metal (paragraph [0084]).
Regarding claim 2, Dixon discloses wherein an area of the metal covering the opposite wall surface is larger than an area of a region of the opposite wall surface irradiated with the measurement light (paragraph [0084]).
Regarding claim 4, Dixon discloses wherein in a case where a side of the flow passage on which the optical system is disposed is defined as an upper side and a side of the flow passage corresponding to the opposite wall surface is defined as a lower side, the opposite wall surface is a curved surface that is convex toward the lower side (paragraph [0040]).
Regarding claim 5, Dixon discloses wherein a flow rate of the fluid flowing through the flow passage is 200 cc/min or more, and in a case where a distance between a first point at which the emission surface and an optical axis intersect with each other and a second point at which the opposite wall surface and the optical axis intersect with each other is denoted by L, “L≤1.5 mm” is satisfied (paragraphs [0040], [0059]).
Regarding claim 8, Dixon discloses wherein at least a part of the main body is transparent, and the fluid flowing through the flow passage is visible from an outside (paragraph [0046], cyclo-olefin polymer is transparent).
Regarding claim 10, Dixon discloses wherein in a case where a distance between a first point at which the emission surface and an optical axis intersect with each other and a second point at which the opposite wall surface and the optical axis intersect with each other is denoted by L, a size of the transparent portion is larger than L (paragraphs [0040], [0046]).
Regarding claim 11, Dixon discloses wherein an outline of a cross-sectional shape of the flow passage as viewed in a direction in which the fluid flows is a curve (paragraph [0040]).
Regarding claim 12, Dixon discloses wherein a resin content of the main body is 95% or more (paragraph [0044]).
Regarding claim 13, Dixon discloses wherein the physical property data is Raman spectral data (paragraph [0006]).
Regarding claim 15, Dixon discloses a measuring method of measuring the physical property data using the flow cell according to claim 1 (paragraph [0005]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon.
Regarding claim 3, Dixon is silent regarding wherein a surface roughness of the opposite wall surface is 1.6 μm or less.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include wherein a surface roughness of the opposite wall surface is 1.6 μm or less as Dixon teaches that the walls are high reflective (paragraph [0085]), and it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, one would chose the claimed surface roughness in order to have a highly reflective surface.
Regarding claim 9, Dixon is silent regarding wherein the transparent portion is a portion not irradiated with the measurement light.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include wherein the transparent portion is a portion not irradiated with the measurement light as Dixon teaches that the all or part of the walls are reflective (paragraph [0084]), and “optical adjustment component is positioned in direct contact with the flow channel. In other embodiments, the cartridge is configured such that the optical adjustment component is in direct contact with the sample flowing through the flow channel. In these embodiments, the optical adjustment component may form a part of the flow channel or the flow channel may include an optical adjustment component integrated directly into the flow channel”, paragraph [0059]. Furthermore, it has been held that the particular placement of an element in a measuring device was held to be an obvious matter of design choice. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). In this case, one would chose the claimed design in order to have view the sample.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon as applied to claim 1 above, and further in view of Golden et al. (US 2003/0049858 A1), hereinafter “Golden”.
Regarding claim 6, Dixon is silent regarding wherein in a case where a distance between a first point at which the emission surface and an optical axis intersect with each other and a condensing position of the measurement light is denoted by d and a distance between the first point and a second point at which the opposite wall surface and the optical axis intersect with each other is denoted by L, “(L/d)≥3.5” is satisfied.
However, Golden teaches a Raman spectroscopy device (abstract) including wherein in a case where a distance between a first point at which the emission surface and an optical axis intersect with each other and a condensing position of the measurement light is denoted by d and a distance between the first point and a second point at which the opposite wall surface and the optical axis intersect with each other is denoted by L, “(L/d)≥3.5” is satisfied (Fig. 5, refs 170, 172, 175, paragraphs [0055]-[0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Dixon with the teaching of Golden by including wherein in a case where a distance between a first point at which the emission surface and an optical axis intersect with each other and a condensing position of the measurement light is denoted by d and a distance between the first point and a second point at which the opposite wall surface and the optical axis intersect with each other is denoted by L, “(L/d)≥3.5” is satisfied in order to have an appropriate amount of light on the sample.
Regarding claim 7, Dixon is silent regarding wherein “d=0.6 mm” is satisfied and “L≥2.1 mm” is satisfied.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include wherein “d=0.6 mm” is satisfied and “L≥2.1 mm” is satisfied as it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, one would chose the claimed surface roughness in order to have an appropriate amount of light on the sample.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Golden, and further in view of Dixon.
Regarding claim 14, Golden teaches a flow cell (abstract, Fig. 4) comprising:
a main body that includes a flow passage through which fluid containing a substance from which physical property data is to be measured flows, (ref 160, paragraph [0054]); and
an optical system which is disposed on a part of a wall surface forming the flow passage and condenses measurement light for the physical property data and of which an emission surface for the measurement light is in contact with the fluid flowing through the flow passage (Fig. 5, ref 170, paragraph [0056]),
wherein in a case where a distance between a first point at which the emission surface and an optical axis intersect with each other and a condensing position of the measurement light is denoted by d and a distance between the first point and a second point at which an opposite wall surface that is the wall surface facing the optical system and the optical axis intersect with each other is denoted by L, “(L/d)≥3.5” is satisfied (Fig. 5, refs 170, 172, 174, paragraphs [0055], [0056]).
Golden is silent regarding wherein the main body contains a resin (Golden teaches quartz).
However, Dixon teaches a flow cell spectrometer (abstract) including wherein the main body contains a resin (paragraphs [0044], [0046]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the device of Golden with the teaching of Dixon by including wherein the main body contains a resin as a known substitute, quartz and resin are optically equivalent.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dixon as applied to claims 1 and 15 above, and further in view of Takahashi et al (US 2020/0399585), hereinafter “Takahashi”.
Regarding claim 16, Dixon is silent regarding wherein the fluid is a cell culture solution
However, Takahashi teaches a cell production method (abstract) using in a measuring method (paragraph [0096]) including wherein the fluid is a cell culture solution (paragraph [0051]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Dixon with the teaching of Takahashi by including wherein the fluid is a cell culture solution as Dixon teaches a biological sample with cells, paragraph [0006], and the method would work with any sample.
Regarding claim 17, Dixon is silent regarding wherein the cell culture solution contains a cell product as the substance.
However, Takahashi teaches a cell production method (abstract) using in a measuring method (paragraph [0096]) including wherein the cell culture solution contains a cell product as the substance (paragraph [0051]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Dixon with the teaching of Takahashi by including wherein the cell culture solution contains a cell product as the substance as Dixon teaches a biological sample with cells, paragraph [0006], and the method would work with any sample.
Regarding claim 18, Dixon is silent regarding wherein the cell culture solution is obtained from a culture vessel in which culture is being performed.
However, Takahashi teaches a cell production method (abstract) using in a measuring method (paragraph [0096]) including wherein the cell culture solution is obtained from a culture vessel in which culture is being performed (paragraph [0061]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Dixon with the teaching of Takahashi by including wherein the cell culture solution is obtained from a culture vessel in which culture is being performed as Dixon teaches a biological sample with cells, paragraph [0006], and the method would work with any sample, one would use a vessel or any bioreactor to culture the cells, as these are well-known apparatuses.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Dixon and Takahashi as applied to claims 1 and 15 and 16 above, and further in view of Ohtsuka (US 2010/0009458).
Regarding claim 19, Dixon is silent regarding wherein the cell culture solution is a solution from which cells have been removed.
However, Ohtsuka teaches a cell measuring method (abstract) including wherein the cell culture solution is a solution from which cells have been removed (paragraph [0152]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Dixon with the teaching of Ohtsuka by including wherein the cell culture solution is a solution from which cells have been removed as the substance as Dixon teaches a biological sample with cells, paragraph [0006], and the method would work with any sample, one would remove a cell so as to only analyze the desired cells.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matsuda (US 2020/0240893) teaches a conventional flow cell and particle counter that could be combined with prior art of record to render the claims obvious.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC J BOLOGNA whose telephone number is (571)272-9282. The examiner can normally be reached Monday - Friday 7:30am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara E Geisel can be reached at (571) 272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC J BOLOGNA/Primary Examiner, Art Unit 2877
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