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 .
Response to Amendment
Applicant’s arguments, see Page 5, Claim Objections, filed 07/30/2026, with respect to claims 3 and 5 have been fully considered and are persuasive. The objection to said claims in Office Action of 04/30/2026 has been withdrawn.
Applicant’s arguments, see Pages 5-6, Double Patenting Claim Rejections, filed 07/30/2026, with respect to claims 1-20 have been fully considered and are acknowledged.
Claims 1-6 and 8-11 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5 and 7 of U.S. Patent No. 11,879,828. Claim 7 was rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,879,828 in view of Chen (US 2006/0256335 A1). These rejections have been withdrawn.
Claims 12-14 and 16-20 were rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 8-9, 4-5 and 12 of U.S. Patent No. 11,879,828. Claim 15 was rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11,879,828 in view of Chen (US
2006/0256335 A1). These rejections have been withdrawn.
Claims 12-14 and 16-20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 9-10 of U.S. Patent No. 11,543,342. Claim 15 was rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,543,342 in view of Chen (US 2006/0256335 A1). These rejections are maintained.
Further, a new ground(s) of nonstatutory double patenting rejection is made in view of claim 15 of U.S. Patent No. 11,879,828, as shown below.
Applicant’s amendments, see Pages 6-7, Claim Rejections Under 35 U.S.C. §103, filed 07/30/2026, with respect to claims 1-20 have been fully considered and are persuasive. Therefore, the rejection of said claims in Office Action of 04/30/2026 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of the previously applied reference US-2014/0339446-A1, and newly found prior art reference US-2019/0323663-A1.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-16 and 18-19 of U.S. Patent No. 11,879,828. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 15-16 and 18-19 of U.S. Patent No. 11,879,828 anticipate each limitation of claims 12 and 16-20 of the instant application, as shown below.
Instant Application 18/985,324
U.S. Patent No. 11,879,828
12. A flow cytometer, comprising:
a transverse-electric (TE) laser diode configured to output a laser beam along an optical axis, the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees;
a flow cell;
a plurality of optical components disposed along the optical axis between the TE laser diode and the flow cell, the plurality of optical components cooperating to focus the laser beam at the flow cell; and
a scatter detector configured to detect scattered light from the flow cell.
15. A flow cytometer of a blood analyzer, comprising:
a transverse-electric (TE) laser diode configured to output a laser beam along an optical axis, the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees;
a flow cell;
a plurality of lenses disposed along the optical axis between the TE laser diode and the flow cell, the plurality of lenses cooperating to focus the laser beam at the flow cell; and
a side scatter detector configured to detect side-scattered light from the flow cell at angles of about 50 degrees to about 120 degrees relative to the optical axis.
16. The flow cytometer according to claim 12, wherein the at least one scatter detector includes a side scatter detector configured to detect side-scattered light from the flow cell.
15. A flow cytometer of a blood analyzer, comprising:
a transverse-electric (TE) laser diode configured to output a laser beam along an optical axis, the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees;
a flow cell;
a plurality of lenses disposed along the optical axis between the TE laser diode and the flow cell, the plurality of lenses cooperating to focus the laser beam at the flow cell; and
a side scatter detector configured to detect side-scattered light from the flow cell at angles of about 50 degrees to about 120 degrees relative to the optical axis.
17. The flow cytometer according to claim 12, wherein the at least one scatter detector includes a forward scatter detector configured to detect forward-scattered light from the flow cell.
16. The flow cytometer according to claim 15, further comprising at least one forward scatter detector configured to detect forward-scattered light from the flow cell at angles less than about 30 degrees relative to the optical axis.
18. The flow cytometer according to claim 12, wherein the plurality of optical components includes a plurality of lenses.
18. The flow cytometer according to claim 15, wherein the plurality of lenses includes a collimating lens and an objective lens.
19. The flow cytometer according to claim 18, wherein the plurality of lenses includes a collimating lens, an objective lens, and at least one cylindrical lens.
18. The flow cytometer according to claim 15, wherein the plurality of lenses includes a collimating lens and an objective lens.
19. The flow cytometer according to claim 18, wherein the plurality of lenses further includes a positive cylindrical lens and a negative cylindrical lens disposed between the collimating lens and the objective lens.
20. The flow cytometer according to claim 19, wherein the at least one cylindrical lens includes a positive cylindrical lens and a negative cylindrical lens.
19. The flow cytometer according to claim 18, wherein the plurality of lenses further includes a positive cylindrical lens and a negative cylindrical lens disposed between the collimating lens and the objective lens.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,879,828 in view of Yamamoto et al. (US 2014/0339446 A1).
Regarding Claim 13 of the instant application, claim 15 of U.S. Patent No. 11,879,828 discloses the flow cytometer according to claim 12, but does not specifically teach that the plurality of optical components includes a polarizer configured to circularly polarize the laser beam focused at the flow cell.
However, Yamamoto, in the same field of flow cytometry, teaches that the plurality of optical components (Figure 3B: a collimator 22, a deflector 23, a λ/4 plate 25, and an objective lens 24; [0097]-[0100]) includes a polarizer (Figure 3B: element 25 is a λ/4 plate; [0100]) configured to circularly polarize the laser beam (Figure 3B; [0100] “λ/4 plate 25 converts a linear polarized light into a circular polarized light”) focused at the flow cell ([0123] “the laser light L is focused or otherwise directed to converge onto an area smaller than each microparticulate sample”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 15 of U.S. Patent No. 11,879,828 with the teachings of Yamamoto, wherein the plurality of optical components includes a polarizer configured to circularly polarize the laser beam focused at the flow cell, because converting linear polarized light into circularly polarized light in a flow cytometer for detecting scatter (particularly side scatter) is primarily done to eliminate or minimize dependency on the orientation of non-spherical particles, whereby circularly polarized light interacts with particles uniformly regardless of their orientation relative to the laser axis, resulting in more consistent scattering data.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,879,828 in view of Yamamoto et al. (US 2014/0339446 A1).
Regarding Claim 14 of the instant application, claim 15 of U.S. Patent No. 11,879,828 discloses the flow cytometer according to claim 13, but does not specifically teach that the polarizer is a quarter wave plate (QWP).
However, Yamamoto, in the same field of flow cytometry, teaches that the polarizer is a quarter wave plate (QWP) (Figure 3B: element 25 is a λ/4 plate; [0100]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 15 of U.S. Patent No. 11,879,828 with the teachings of Yamamoto, wherein the polarizer is a quarter wave plate (QWP), because QWP aids in managing polarization-dependent scattering, which is critical for minimizing noise and improving the sensitivity of detecting small particles or weak signals.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,879,828 in view of Chen (US 2006/0256335 A1).
Regarding Claim 15 of the instant application, claim 15 of U.S. Patent No. 11,879,828 discloses the flow cytometer according to claim 13, but does not specifically teach that the polarizer is a birefringent polarizer.
However, Chen, in the same field of flow cytometry, teaches that the polarizer is a birefringent polarizer (Figure 4: elements 1 and 3 are wedge elements of a birefringent material; [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify claim 15 of U.S. Patent No. 11,879,828 with the teachings of Chen, wherein the polarizer is a birefringent polarizer, because birefringent polarizers in flow cytometry enhance detection of anisotropic particles by analyzing polarization changes in scattered light.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 2014/0339446 A1) in view of Misener et al. (US 2019/0302391 A1).
Regarding independent Claim 1, Yamamoto discloses a flow cytometer, comprising:
a laser (Figure 3B: element 21 is a laser source; [0100]) configured to output a laser beam (Figure 3B; [0097] “laser source 21 can produce laser light having wavelengths of 405 nm, 488 nm, and 650 nm”) along an optical axis ([0101] “the optical axis of the laser light L”);
a flow cell (Figure 3B: element 1 is a flow chamber; [0099]);
a plurality of optical components (Figure 3B: a collimator 22, a deflector 23, a λ/4 plate 25, and an objective lens 24; [0097]-[0100]) disposed along the optical axis ([0028] “an optical axis of the incident light”) between the laser diode (Figure 3B: element 21 is a laser source; [0100]) and the flow cell (Figure 3B: element 1 is a flow chamber; [0099]), the plurality of optical components (Figure 3B: a collimator 22, a deflector 23, a λ/4 plate 25, and an objective lens 24; [0097]-[0100]) configured to cooperate to focus the laser beam at the flow cell (Figure 3B; [0097] “focus the laser light L on the micro flow channel 12”) and including a polarizer (Figure 3B: element 25 is a λ/4 plate; [0100]) configured to circularly polarize the laser beam (Figure 3B; [0100] “λ/4 plate 25 converts a linear polarized light into a circular polarized light”) focused at the flow cell ([0123] “the laser light L is focused or otherwise directed to converge onto an area smaller than each microparticulate sample”); and
at least one scatter detector (Figure 4A; [0102] “photodetectors 34 and 35”) configured to detect scattered light ([0102] “for detecting transmitted or forward-scattered light”) from the flow cell (Figure 4A; [0102] “light Lct from the flow chamber 1”), but does not specifically teach:
a laser diode; and
wherein the polarizer is bonded to an optical component of the plurality of optical components to maintain a pre-determined orientation of the polarizer relative to the optical component.
However, Misener, in the same field of flow cytometry, teaches a laser diode (Figure 2: element 240 is a laser diode; [0050]) configured to output a laser beam along an optical axis (Figure 2; [0054] “a beam emitted from laser diode 240 is … pointing in a direction co-axial with the optical axis of collimating lens 238”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto with the teachings of Misener, for a laser diode configured to output a laser beam along an optical axis, because laser diodes are tiny semiconductor packages, which allow manufacturers to build smaller, benchtop, or point-of-care flow cytometers.
Yamamoto is also silent with respect to: wherein the polarizer is bonded to an optical component of the plurality of optical components to maintain a pre-determined orientation of the polarizer relative to the optical component.
However, Yamamoto teaches the polarizer (Figure 3B: element 25 is a λ/4 plate; [0100]) and an optical component (Figure 3B: element 24 is an objective lens; [0100]) of the plurality of optical components (Figure 3B: a collimator 22, a deflector 23, a λ/4 plate 25, and an objective lens 24; [0097]-[0100]). Further, it is common and known in the art to bond a polarizer to a lens for providing stability and alignment.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto, such that the polarizer is bonded to an optical component of the plurality of optical components to maintain a pre-determined orientation of the polarizer relative to the optical component (it has been held that a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (1987)), because bonding a polarizer directly to a lens in a flow cytometry system ensures precise alignment, eliminates internal air-glass reflections, and creates a compact, rugged optical subassembly.
Regarding Claim 2, modified Yamamoto discloses the flow cytometer according to claim 1, and the at least one scatter detector (see claim 1 rejection), but does not specifically teach that the at least one scatter detector includes a side scatter detector configured to detect side-scattered light from the flow cell.
However, Yamamoto, in a different embodiment – see Figure 1 – teaches that the at least one scatter detector includes a side scatter detector (Figure 1: element 4 is a detection optical system; [0081]) configured to detect side-scattered light (Figure 1; [0082] “fluorescence/side-scattered light L_F-SS”) from the flow cell (Figure 1; [0082] “fluorescence/side-scattered light L_F-SS can be output from the flow chamber 1”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto with the embodiment of Figure 1, wherein that the at least one scatter detector includes a side scatter detector configured to detect side-scattered light from the flow cell, because a side scatter detector determines the internal complexity and granularity of cells in a sample.
Regarding Claim 3, modified Yamamoto discloses the flow cytometer according to claim 2, and the side scatter detector (see claim 2 rejection), but does not specifically teach that the side scatter detector is configured to detect side-scattered light from the flow cell at angles of about 50 degrees to about 120 degrees relative to the optical axis.
However, Yamamoto teaches that the side scatter detector (Figure 1: element 4 is a detection optical system; [0081]) is configured to detect side-scattered light (Figure 1; [0082] “fluorescence/side-scattered light L_F-SS”) from the flow cell (Figure 1; [0082] “fluorescence/side-scattered light L_F-SS can be output from the flow chamber 1”) at angles of about 50 degrees to about 120 degrees relative to the optical axis (Figure 1; [0082] “fluorescence and side-scattered light which are output in a direction substantially perpendicular to the optical axis of the laser light L”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto with the embodiment of Figure 1, wherein the side scatter detector is configured to detect side-scattered light from the flow cell at angles of about 50 degrees to about 120 degrees relative to the optical axis, to efficiently capture light refracted, reflected, and diffracted by internal cellular structures—such as granules, vacuoles, and the nucleus—while avoiding the intense, blinding unscattered laser beam traveling along the forward axis.
Regarding Claim 4, modified Yamamoto discloses the flow cytometer according to claim 1, wherein the at least one scatter detector (Figure 4A; [0102] “photodetectors 34 and 35”) includes a forward scatter detector (Figure 4A; [0103] “photodetector 34 detects the light intensity of the transmitted light”) configured to detect forward-scattered light (Figure 4A; [0102] “for detecting transmitted or forward-scattered light”) from the flow cell (Figure 4A; [0102] “light Lct from the flow chamber 1”).
Regarding Claim 5, modified Yamamoto discloses the flow cytometer according to claim 4, wherein the forward scatter detector (Figure 4A; [0103] “photodetector 34 detects the light intensity of the transmitted light”) is configured to detect forward scattered light (Figure 4A; [0102] “for detecting transmitted or forward-scattered light”) from the flow cell (Figure 4A; [0102] “light Lct from the flow chamber 1”) at angles less than about 30 degrees relative to the optical axis ([0101] ““forward-scattered light” refers to light that is scattered at a small angle with respect to the traveling direction of the optical axis of the laser light L”).
Regarding Claim 6, modified Yamamoto discloses the flow cytometer according to claim 1, wherein the polarizer is a quarter wave plate (QWP) (Figure 3B: element 25 is a λ/4 plate; [0100]).
Regarding Claim 8, modified Yamamoto discloses the flow cytometer according to claim 1, wherein the plurality of optical components (Figure 3B: a collimator 22, a deflector 23, a λ/4 plate 25, and an objective lens 24; [0097]-[0100]; Figure 4A: an objective lens 31; [0102]) includes a plurality of lenses (Figure 3B: objective lens 24; Figure 4A: objective lens 31).
Regarding Claim 9, modified Yamamoto discloses the flow cytometer according to claim 8, wherein the plurality of lenses includes an objective lens (Figure 3B: objective lens 24; Figure 4A: objective lens 31), but does not specifically teach a collimating lens, and at least one cylindrical lens.
However, Misener, in the same field of flow cytometry, teaches that the plurality of lenses includes a collimating lens, and at least one cylindrical lens (Figure 2: elements 238, 276, 286, 296 are lenses; [0049] “a collimating lens 238”; [0060] “Lens 276 is configured as a positive cylindrical lens”; [0060] “Lens 286 is configured as a negative cylindrical lens”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto with the teachings of Misener, wherein the plurality of lenses includes a collimating lens, and at least one cylindrical lens, because a collimating lens stabilizes the beam diameter and ensures predictable light delivery before any further shaping occurs, and a cylindrical lens focuses light in only one single dimension (horizontally or vertically).
Regarding Claim 10, modified Yamamoto discloses the flow cytometer according to claim 9, wherein the at least one cylindrical lens includes a positive cylindrical lens (Misener, Figure 2: element 276 is a positive cylindrical lens; [0060]) and a negative cylindrical lens (Misener, Figure 2: element 286 is a negative cylindrical lens; [0060]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 2014/0339446 A1) and Misener et al. (US 2019/0302391 A1) as applied to claim 1 above, and further in view of Chen (US 2006/0256335 A1).
Regarding Claim 7, modified Yamamoto discloses the flow cytometer according to claim 1, and the polarizer (see claim 1 rejection), but does not specifically teach that the polarizer is a birefringent polarizer.
However, Chen, in the same field of flow cytometry, teaches that the polarizer is a birefringent polarizer (Figure 4: elements 1 and 3 are wedge elements of a birefringent material; [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto with the teachings of Chen, wherein the polarizer is a birefringent polarizer, because birefringent polarizers in flow cytometry enhance detection of anisotropic particles by analyzing polarization changes in scattered light.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 2014/0339446 A1) and Misener et al. (US 2019/0302391 A1) as applied to claim 1 above, and further in view of Wagner et al. (US 2004/0042008 A1).
Regarding Claim 11, modified Yamamoto discloses the flow cytometer according to claim 1, and the laser diode (see claim 1 rejection), but does not specifically teach that the laser diode is a transverse-electric (TE) laser diode.
However, Wagner, in the same field of scattered light detection, teaches that the laser diode (Figure 2: element 105 is a laser diode; [0032]) is a transverse-electric (TE) laser diode (Figure 2; [0038] “the TE polarization mode should be along the X-axis. Therefore, a retarder 114 is included in beam shaping optics 113. Retarder 114 is preferably a one-half wave plate axially aligned with laser beam 121 which rotates the polarization 90 degrees so that the TE mode is along the X-axis”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Yamamoto with the teachings of Wagner, wherein the laser diode is a transverse-electric (TE) laser diode, because transverse-electric laser modes, specifically the fundamental Gaussian mode, are essential in flow cytometry for providing consistent, uniform illumination to cells as they pass through the interrogation point, whereby this mode ensures that the intensity of the light is uniformly distributed (Gaussian), which is necessary for the accurate, reproducible scattering and fluorescence measurements of single cells.
Claim(s) 12 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener et al. (US 2019/0302391 A1) in view of Wagner et al. (US 2004/0042008 A1) and Rudy et al. (US 2019/0323663 A1).
Regarding independent Claim 12, Misener discloses a flow cytometer, comprising:
a laser diode (Figure 2: element 240 is a laser diode; [0050]) configured to output a laser beam along an optical axis (Figure 2; [0054] “a beam emitted from laser diode 240 is … pointing in a direction co-axial with the optical axis of collimating lens 238”);
a flow cell (Figure 2: element 340 is a flow cell; [0063]);
a plurality of optical components (Figure 2: elements 238, 276, 286, 296 are lenses; [0049] “a collimating lens 238”; [0060] “Lens 276 is configured as a positive cylindrical lens”; [0060] “Lens 286 is configured as a negative cylindrical lens”; [0060] “Lens 296 is configured as a cylindrical objective lens”) disposed along the optical axis (Figure 2; [0054] “the optical axis of collimating lens 238”) between the laser diode (Figure 2: element 240 is a laser diode; [0050]) and the flow cell (Figure 2: element 340 is a flow cell; [0063]), the plurality of optical components cooperating to focus the laser beam at the flow cell (Figure 14: lens elements 238, 276, 286, 296 are focusing the laser beam at flow cell element 340; [0068]); and
a scatter detector (Figures 1 and 2: element 400 is a sensor assembly; [0075] “sensor assembly 400 includes a forward scatter sub-assembly 410 and a side scatter sub-assembly 420”) configured to detect scattered light ([0044] “for both forward and side scatter detection”) from the flow cell (Figures 1 and 2: element 340 is a flow cell; [0063]), but does not specifically teach:
a transverse-electric (TE) laser diode, the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees.
However, Wagner, in the same field of scattered light detection, teaches a transverse-electric (TE) laser diode (Figure 2; [0038] “the TE polarization mode should be along the X-axis. Therefore, a retarder 114 is included in beam shaping optics 113. Retarder 114 is preferably a one-half wave plate axially aligned with laser beam 121 which rotates the polarization 90 degrees so that the TE mode is along the X-axis”) configured to output a laser beam (Figure 2: element 121 is a laser beam; [0034]) along an optical axis (Figure 2; [0044] “laser beam 121 which passes through first lens 109, second lens 111, retarder 114, third lens 116”, wherein “first lens 109, second lens 111, retarder 114, third lens 116” are interpreted to lie along an optical axis).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Misener with the transverse-electric (TE) laser diode of Wagner, for a transverse-electric (TE) laser diode configured to output a laser beam along an optical axis, because transverse-electric laser modes, specifically the fundamental Gaussian mode, are essential in flow cytometry for providing consistent, uniform illumination to cells as they pass through the interrogation point, whereby this mode ensures that the intensity of the light is uniformly distributed (Gaussian), which is necessary for the accurate, reproducible scattering and fluorescence measurements of single cells.
Misener is also silent with respect to: the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees.
However, Rudy, in the same field of laser diodes, teaches the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees ([0362] “typical full width at half maximum (FWHM) beam divergences range from about 5-20 degrees in the slow axis and 10 to 40 degrees in the fast axis”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Misener with the teachings of Rudy, for the laser beam having a fast axis full width at half maximum (FWHM) divergence of from about 16 degrees to about 25 degrees, because this allows the system to accurately resolve individual cells passing through the stream, govern the transit time (time-of-flight), and cleanly separate signals from closely spaced or rapidly transiting particles.
Regarding Claim 16, modified Misener discloses the flow cytometer according to claim 12, wherein the at least one scatter detector includes a side scatter detector (Figures 1 and 2: element 400 is a sensor assembly; [0075] “sensor assembly 400 includes a forward scatter sub-assembly 410 and a side scatter sub-assembly 420”) configured to detect side-scattered light ([0044] “for both forward and side scatter detection”) from the flow cell (Figures 1 and 2: element 340 is a flow cell; [0063]).
Regarding Claim 17, modified Misener discloses the flow cytometer according to claim 12, wherein the at least one scatter detector includes a forward scatter detector (Figures 1 and 2: element 400 is a sensor assembly; [0075] “sensor assembly 400 includes a forward scatter sub-assembly 410 and a side scatter sub-assembly 420”) configured to detect forward-scattered light ([0044] “for both forward and side scatter detection”) from the flow cell (Figures 1 and 2: element 340 is a flow cell; [0063]).
Regarding Claim 18, modified Misener discloses the flow cytometer according to claim 12, wherein the plurality of optical components includes a plurality of lenses (Figure 2: elements 238, 276, 286, 296 are lenses; [0049] “a collimating lens 238”; [0060] “Lens 276 is configured as a positive cylindrical lens”; [0060] “Lens 286 is configured as a negative cylindrical lens”; [0060] “Lens 296 is configured as a cylindrical objective lens”).
Regarding Claim 19, modified Misener discloses the flow cytometer according to claim 18, wherein the plurality of lenses includes a collimating lens, an objective lens, and at least one cylindrical lens (Figure 2: elements 238, 276, 286, 296 are lenses; [0049] “a collimating lens 238”; [0060] “Lens 276 is configured as a positive cylindrical lens”; [0060] “Lens 286 is configured as a negative cylindrical lens”; [0060] “Lens 296 is configured as a cylindrical objective lens”).
Regarding Claim 20, modified Misener discloses the flow cytometer according to claim 19, wherein the at least one cylindrical lens includes a positive cylindrical lens (Figure 2: element 276 is a positive cylindrical lens; [0060]) and a negative cylindrical lens (Figure 2: element 286 is a negative cylindrical lens; [0060]).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Misener et al. (US 2019/0302391 A1) and Wagner et al. (US 2004/0042008 A1) and Rudy et al. (US 2019/0323663 A1) as applied to claim 12 above, and further in view of Yamamoto et al. (US 2014/0339446 A1).
Regarding Claim 13, modified Misener discloses the flow cytometer according to claim 12, and the plurality of optical components (see claim 12 rejection), but does not specifically teach that the plurality of optical components includes a polarizer configured to circularly polarize the laser beam focused at the flow cell.
However, Yamamoto, in the same field of flow cytometry, teaches that the plurality of optical components (Figure 3B: a collimator 22, a deflector 23, a λ/4 plate 25, and an objective lens 24; [0097]-[0100]) includes a polarizer (Figure 3B: element 25 is a λ/4 plate; [0100]) configured to circularly polarize the laser beam (Figure 3B; [0100] “λ/4 plate 25 converts a linear polarized light into a circular polarized light”) focused at the flow cell ([0123] “the laser light L is focused or otherwise directed to converge onto an area smaller than each microparticulate sample”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Misener with the teachings of Yamamoto, wherein the plurality of optical components includes a polarizer configured to circularly polarize the laser beam focused at the flow cell, because converting linear polarized light into circularly polarized light in a flow cytometer for detecting scatter (particularly side scatter) is primarily done to eliminate or minimize dependency on the orientation of non-spherical particles, whereby circularly polarized light interacts with particles uniformly regardless of their orientation relative to the laser axis, resulting in more consistent scattering data.
Regarding Claim 14, modified Misener discloses the flow cytometer according to claim 13, and the polarizer (see claim 13 rejection), but does not specifically teach that the polarizer is a quarter wave plate (QWP).
However, Yamamoto, in the same field of flow cytometry, teaches that the polarizer is a quarter wave plate (QWP) (Figure 3B: element 25 is a λ/4 plate; [0100]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Misener with the teachings of Yamamoto, wherein the polarizer is a quarter wave plate (QWP), because QWP aids in managing polarization-dependent scattering, which is critical for minimizing noise and improving the sensitivity of detecting small particles or weak signals.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Misener et al. (US 2019/0302391 A1) and Wagner et al. (US 2004/0042008 A1) and Rudy et al. (US 2019/0323663 A1) and Yamamoto et al. (US 2014/0339446 A1) as applied to claim 13 above, and further in view of Chen (US 2006/0256335 A1).
Regarding Claim 15, modified Misener discloses the flow cytometer according to claim 13, and the polarizer (see claim 13 rejection), but does not specifically teach that the polarizer is a birefringent polarizer.
However, Chen, in the same field of flow cytometry, teaches that the polarizer is a birefringent polarizer (Figure 4: elements 1 and 3 are wedge elements of a birefringent material; [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cytometer of Misener with the teachings of Chen, wherein the polarizer is a birefringent polarizer, because birefringent polarizers in flow cytometry enhance detection of anisotropic particles by analyzing polarization changes in scattered light.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Akbar H Rizvi whose telephone number is (571) 272-5085. The examiner can normally be reached Monday - Friday, 9:30 am - 6:30 pm.
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/AKBAR H. RIZVI/
Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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