DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 § 102
2. 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.
3. Claims 1-6, 8, 10-14, 16-18 and 21-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Pub. No. 2020/0393360 A1 by Proskurowski et al. (hereinafter Proskurowski).
Regarding Claim 1, Proskurowski teaches a sensor unit of a spectroscopic analysis apparatus (Fig. 4, 9, Abstract), the sensor unit comprising (Fig. 1-17):
a distal end portion (Fig. 4 @ 418, Par. [0040]; Fig. 9 @ 916, end of the tube is the distal end, Par. [0056]) that includes a built-in optical system (Fig. 4 @ 460, Par. [0040, 0042]) for irradiating a measurement target substance for physical property data with measurement light to take in return light (Par. [0040, 0042]) from the measurement target substance (Fig. 4 @ 462, Par. [0040, 0042]) and that is attached to a container (Fig. 4 @ 412, Par. [0040-0042]) for fluid containing the measurement target substance (Par. [0040-0042]),
wherein the distal end portion (Fig. 4 @ 418, Par. [0040]; Fig. 9 @ 916, end of the tube is the distal end, Par. [0056]) includes
a facing wall surface (Fig. 4 @ 412, 462, bottom/lower wall surface, i.e. the facing wall surface) that faces an emission surface (Fig. 4 @ 412, 462, top/upper wall surface, i.e. the emission surface) of the measurement light of the optical system (Fig. 4 @ 430, Par. [0042]), and
a holding portion (Fig. 4 @ 412, Par. [0040-0043]) that protrudes from an emission surface side (Fig. 4 @ 412, 462, top/upper wall surface, i.e. the emission surface) to a facing wall surface side (Fig. 4 @ 412, 462, bottom wall surface, i.e. the facing wall surface), that holds the facing wall surface (Fig. 4 @ 412, 462, bottom wall surface, i.e. the facing wall surface) in a state in which a space (Fig. 4 @ 414, Par. [0040]) for the fluid to flow is provided (Par. [0040]) between the emission surface (Fig. 4 @ 412, 462, top/upper wall surface, i.e. the emission surface) and the facing wall surface (Fig. 4 @ 412, 462, bottom wall surface, i.e. the facing wall surface), and that includes an inflow port (Fig. 4 @ 415, Par. [0041]) and an outflow port (Fig. 4 @ 417, Par. [0041]) for the fluid (Fig. 4 @ 414, Par. [0040]) and side wall surfaces disposed on both sides in a flow direction of the fluid (Fig. 4 @ 412, Fig. 5 @ 512, Fig. 9 @ 912, illustrates such configuration).
Regarding Claim 2, Proskurowski teaches the container is a flow cell having a flow channel through which the fluid flows (Fig. 4 @ 412, Par. [0040]: flow cell device (FCD) 412).
Regarding Claim 3, Proskurowski teaches the distal end portion is attached to the flow cell containing a resin (Abstract, Par. [0005]).
Regarding Claim 4, Proskurowski teaches the distal end portion is attached to a plurality of types of the flow cells having different flow channel diameters (Par. [0039, 0047, 0052, 0064]. Note: pressure needs to match the diameter. Applicant’s admitted prior art JP2020-511635A (US 2020/0393360 A1 by Proskurowski et al. (hereinafter Proskurowski), cited Primary reference). Applicant disclosed in instant specification, Par. [0002]: The flow cell is a type of container for the fluid containing the measurement target substance. JP2020-511635A describes the flow cell having various flow channel diameters).
Regarding Claim 5, Proskurowski teaches a metal is disposed on at least a part of a surface of the facing wall surface (Abstract, Par. [0034, 0046]: a FCD 512 included of a metal, alloy, polymer, ceramic, composite, glass, etc).
Regarding Claim 6, Proskurowski teaches an area of the metal on the facing wall surface is larger than an irradiation area of the measurement light on the facing wall surface (Fig. 4 @ 430, 425, 412, illustrates such configuration).
Regarding Claim 8, Proskurowski teaches the facing wall surface is a flat surface (Fig. 1 @ 412, illustrates such configuration).
Regarding Claim 10, Proskurowski teaches a body portion containing a resin (Abstract, Par. [0034, 0046]: a FCD 512 included of a metal, alloy, polymer, ceramic, composite, glass, etc).
Regarding Claim 11, Proskurowski teaches the inflow port and the outflow port have a circular shape or a rectangular shape (Fig. 5, 7, 9, illustrates such configuration).
Regarding Claim 12, Proskurowski teaches a focusing position of the measurement light from the optical system is located between the emission surface and the facing wall surface (Fig. 4 @ 430, illustrates such configuration).
Regarding Claim 13, Proskurowski teaches the optical system includes a lens having a positive refractive power (Fig. 4 @ 460, spherical lens).
Regarding Claim 14, Proskurowski teaches the optical system further includes an optical element of which an emission surface of the measurement light is a flat surface (Par. [0026]: Optical energy can then be passed into an analysis zone defined by the optics of the optical analysis device and the SOE. Par. [0029]).
Regarding Claim 16, Proskurowski teaches a metal is disposed on at least a part of a surface of the side wall surface (Abstract, Par. [0034, 0046]: a FCD 512 included of a metal, alloy, polymer, ceramic, composite, glass, etc).
Regarding Claim 17, Proskurowski teaches an interval between the emission surface and the facing wall surface is fixed (Fig. 4 @ 462, illustrates such configuration).
Regarding Claim 18, Proskurowski teaches the physical property data is Raman spectral data (Abstract, Par. [0004]).
Regarding Claim 21, Proskurowski teaches the container (Fig. 4 @ 412, Par. [0040-0042]) to which the distal end portion (Fig. 4 @ 418, Par. [0040]; Fig. 9 @ 916, end of the tube is the distal end, Par. [0056]) is attached (Fig. 4, illustrates such configuration).
Regarding Claim 22, Proskurowski teaches in a case in which the container (Fig. 4 @ 412, Par. [0040-0042]) is the flow cell (Fig. 4 @ 412, Par. [0040]: flow cell device (FCD) 412) and the distal end portion (Fig. 4 @ 418, Par. [0040]; Fig. 9 @ 916, end of the tube is the distal end, Par. [0056]) is attached to the flow cell (Fig. 4 @ 412, Par. [0040]: flow cell device (FCD) 412), a flow channel through which the fluid flows is present on an inner side (Fig. 4 @ 412, Par. [0040]: flow cell device (FCD) 412) and an outer side of the distal end portion (Fig. 4 @ 418, Par. [0040]; Fig. 9 @ 916, end of the tube is the distal end, Par. [0056]).
Regarding Claim 23, Proskurowski teaches in a case in which the container (Fig. 4 @ 412, Par. [0040-0042]) is the flow cell (Fig. 4 @ 412, Par. [0040]: flow cell device (FCD) 412) and the distal end portion (Fig. 4 @ 418, Par. [0040]; Fig. 9 @ 916, end of the tube is the distal end, Par. [0056]) is attached to the flow cell (Fig. 4 @ 412, Par. [0040]: flow cell device (FCD) 412), a line connecting centers of the inflow port (Fig. 4 @ 415; Fig. 5 @ 515; Fig. 9 @ 919; Fig. 13 @ 1320) and the outflow port (Fig. 4 @ 417; Fig. 5 @ 517; Fig. 9 @ 921; Fig. 13 @ 1340) is parallel to the flow direction (Fig. 4-5, 9, 13).
Regarding Claim 24, Proskurowski teaches measuring the physical property data by using the sensor unit of a spectroscopic analysis (Abstract, Par. [0004, 0030]).
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Proskurowski.
Regarding Claim 7, Proskurowski teaches a surface roughness of the facing wall surface (Par. [0079]: FCD can be constructed of nearly any material. A consumable FCD can include a suitable polymer thus teaches surface roughness) but does not explicitly teach is equal to or less than 1.6 m.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use optimum value in order to optimize the system ensuring a sufficient resolution when detecting optical signal. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). (MPEP 2144.05).
Regarding Claim 9, Proskurowski teaches wherein, in a case in which the emission surface side is defined as an upper side and the facing wall surface side is defined as a lower side (See Claim 1 rejection. Also see Fig. 1 @412) but does not explicitly teach the facing wall surface is a curved surface that protrudes to the lower side.
However, it is well known to make elements of a system adjustable, where adjustability is needed such that the facing wall surface is a curved surface that protrudes to the lower side in order to optimize the system configuration based on variations of the geometrical limitations of the system. It has been held that the provision of adjustability, where needed, involves only routine skill in the art. In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA 1954).
6. Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Proskurowski in view of US Patent Pub. No. 2019/0309255 A1 by et al. (hereinafter Ott).
Regarding Claims 19-20, Proskurowski teaches the fluid (See Claim 1 rejection above but does not explicitly teach a turbidity of the fluid is equal to or greater than 250 NTU and equal to or less than 1000 NTU and wherein the fluid is a cell culture liquid.
However, Ott teaches measuring turbidity of the fluid (Par. [0054, 0076, 0082, 0129, 0132]) ) and wherein the fluid is a cell culture liquid (Abstract, Par. [0004-0005, 0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify Proskurowski by Ott as taught above such that measuring turbidity of the fluid and wherein the fluid is a cell culture liquid is accomplished in order to prevent the complete failure of a batch during the production process, in particular during the cultivation (Ott, Par. [0007]).
Still lacking limitation such as: turbidity of the fluid is equal to or greater than 250 NTU and equal to or less than 1000 NTU.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use optimum range in order to mark the boundary of contamination triggering unique optical behaviors and regulatory actions. Since it has been held that where the general condition of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (MPEP 2144.05).
Allowable Subject Matter
7. Claim 15 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.
Reason for Allowance
8. The following is a statement of reasons for the indication of allowable subject matter:
9. As to Claim 15, the prior arts of record alone or in combination fails to teach or suggest the claimed limitation of “a thickness of the optical element in an optical axis direction is equal to or greater than a half of a distance between a point at which an emission surface of the lens intersects an optical axis and a focusing position of the measurement light and equal to or less than the distance” along with all other limitations of claim 15.
10. Proskurowski et al. (US 2020/0393360 A1) teaches a sensor unit of a spectroscopic analysis apparatus, the sensor unit comprising: a distal end portion that includes a built-in optical system for irradiating a measurement target substance for physical property data with measurement light to take in return light from the measurement target substance and that is attached to a container for fluid containing the measurement target substance but fails to teach the claimed limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
Additional Prior Art
11. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The reference listed teaches of other prior art method/system of determining size of microparticles.
US Patent Pub. No. 2015/0260638 A1 by Doyl et al. (Fig. 1).
US Patent Pub. No. 2020/0141870 A1 by Slater (Fig. 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMIL AHMED whose telephone number is (571)272-1950. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM.
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/JAMIL AHMED/Primary Examiner, Art Unit 2877
