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 .
Election/Restrictions
Applicant’s election of Group I, Claims 1-15, in the reply filed on May 27, 2026 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant of 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. This election was made without traverse in the reply filed on May 27, 2026.
Priority
Receipt is acknowledged of certified copies of papers (SG10202302946R – filed on 10/18/2023) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/23/2023 and 11/27/2023 have been certified and made of record.
Claim Objections
Claim 4 is objected to because of the following informalities:
“The microfluid device of claim 1, wherein the sheath inlet channels are configured to have a sheath fluid driven toward the semi-spiral-shaped channels at a higher flow rate than a sample in the sample inlet channels driven toward the semi-spiral-shaped channels” should read “The microfluidic device of claim 1, wherein the sheath inlet channels are configured to have a sheath fluid driven toward the semi-spiral-shaped channels at a higher flow rate than a sample in the sample inlet channels driven toward the semi-spiral-shaped channels.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “two sample inlet channels” (Claim 7) and “two sheath inlet channels” (Claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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 14 and 15 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. Specifically, the claim limitation “where the at least two outlet ports (A) comprises two outlet ports (B)” is unclear regarding the structure, whether each outlet port comprises two outlet ports or is a redundancy. Furthermore, it is unclear whether the two outlet ports (A) differ from the other outlet ports (B), as pointed out by labels (A) and (B) used herein. Claim 15 depends on claim 14 fails to cure the deficiencies of the claim, and is therefore included in this rejection. For examination purposes, if a claim element teaches a device with at least two outlet ports, wherein the two outlet ports include a first outlet port and second outlet port with a second outlet channel connected to said port, this will be seen as meeting this claim limitation.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et al. (US 20220395831 A1) (referenced in 892).
It is noted that while US 20220395831 A1 has a common inventor with the instant application, the US 20220395831 A1 was filed more than a year before the earliest effective filing date of the instant application.
Regarding claim 1, Hou et al. teaches a microfluidic device (abstract, See annotated FIG. 1A on following page) comprising:
semi-spiral shaped channels in fluid communication with (i) at least two inlet ports (Inlets, FIG. 1A) and (ii) at least two outlet ports (O1, O2, O3, O4), wherein the at least two inlet ports comprise:
a sample inlet port and a sheath inlet port (Annotated FIG. 1A),
wherein the sample inlet port is in fluid communication with sample inlet channels, each of the sample inlet channels is connected to one semi-spiral-shaped channel (Annotated FIG. 1A), and wherein the sheath inlet port is in fluid communication with sheath inlet channels, each of the sheath inlet channels is connected to one semi-spiral-shaped channel (Annotated FIG. 1A);
wherein the at least two outlet ports comprise a first outlet port and each of the semi-spiral shaped channels has a first outlet channel connected to the first outlet port (FIG. 1A, Outlets – O1, O2, O3, O4 – and their respective channels),
wherein each first outlet channel is longer than any other outlet channel connected to the same semi-spiral shaped channel (abstract). Therefore, the claim is anticipated.
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Regarding claim 2, Hou et al. teaches the microfluidic device of claim 1. Hou et al. teaches “the present method may include introducing a blood sample into the inlet port proximal to the outer wall and introducing a sheath fluid into the inlet port proximal to the inner wall to form a diluted sample in the spiral-shaped channel” (para. [0081]). Thus, this anticipates the claim limitation.
Regarding claim 3, Hou et al. teaches the microfluidic device of claim 1. Regarding the limitation “the sheath inlet port is configured to have a sheath fluid introduced at a higher flow rate than a sample introduced into the sample inlet port”, it has been held that a claim containing 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 (MPEP § 2114 II).
Therefore, the sheath inlet port employed by Hou et al. would be fully capable of achieving every intended use because Hou et al. teaches “introducing the blood sample and the sheath fluid may include introducing the sheath fluid at a higher flow rate compared to a flow rate for introducing the blood sample” (para. [0088]), and would be structurally capable of being configured to have a sheath fluid introduced at a higher flow rate than a sample introduced into the sample inlet port. Regarding claim 4, Hou et al. teaches the microfluidic device of claim 1. Regarding the limitation “the sheath inlet channels are configured to have a sheath fluid driven toward the semi-spiral shaped channels at a higher flow rate than a sample in the sample inlet channels drive toward the semi-spiral shaped channels”, it has been held that a claim containing 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 (MPEP § 2114 II).
Therefore, the sheath inlet channels employed by Hou et al. would be fully capable of achieving every intended use because Hou et al. teaches “introducing the blood sample and the sheath fluid may include introducing the sheath fluid at a higher flow rate compared to a flow rate for introducing the blood sample” (para. [0088]), and would be structurally capable of being configured to have a sheath fluid driven toward the semi-spiral-shaped channels at a higher flow rate than a sample in the sample inlet channels driven toward the semi-spiral shaped channels.
Regarding claim 5, Hou et al. teaches the device of claim 1. Hou et al. teaches the specific example of the microfluidic device of FIG. 1A, wherein the sample and sheath inlets are 50 μm wide and 250 μm wide, respectively (para. [0127]). It has been established that a specific example in the prior art which is within a claimed range anticipates the range (MPEP § 2131.03 I). Thus, the specific example anticipates the claimed range (50 to 1000 μm), since 50 μm wide is within the sample inlet port range.
Regarding claim 6, Hou et al. teaches the device of claim 1. Hou et al. teaches the specific example of the microfluidic device of FIG. 1A, wherein the sample and sheath inlets are 50 μm wide and 250 μm wide, respectively (para. [0127]). It has been established that a specific example in the prior art which is within a claimed range anticipates the range (MPEP § 2131.03 I). Thus, the specific example anticipates the claimed range (50 to 1000 μm), since 250 μm wide is within the sheath inlet port range. Regarding claim 14, Hou et al. teaches the device of claim 1. Hou et al. teaches at least two outlet ports in microfluidic device (O1, O2, O3, O4, FIG. 1A), with a second outlet channel connected to the second port (See annotated FIG. 1A). Thus, the claim is anticipated.
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. (already referenced) in view of Collins (US 20130244906 A1).
Regarding claim 7, Hou et al. teaches the microfluidic device of claim 1. Hou et al. fails to teach that sample inlet channels comprises two sample inlet channels, which are bifurcated from the sample inlet port. Collins teaches a microfluidic device for cell and molecular diagnostics (abstract). Collins further teaches that “the sample with disaggregated cells is loaded into the cell inlet in the microfluidic chip and is split in to many channels using binary splitters” (para. [0052]), as the binary splitters enable cells to be equally split in all the splitter channels (para. [0052]). The binary splitters employed by Collins are structurally the same as the bifurcating from the sample inlet port.
It would have been prima facie obvious to one of ordinary skill in the art to use Collins’ teaching of binary splitters in Hou et al.’s microfluidic device because binary splitters enable cells to be equally split in all the splitter channels. This method of improving Hou et al.’s microfluidic device was within the ability of one ordinary skill in the art based on the teachings of Collins. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hou et al. and Collins to obtain the claimed invention as specified in claim 7.
Regarding claim 8, Hou et al. teaches the microfluidic device of claim 1. Hou et al. fails to teach that sheath inlet channels comprise two sheath inlet channels, which are bifurcated from the sheath inlet port. Collins teaches a microfluidic device for cell and molecular diagnostics (abstract) with binary splitters. Collins teaches that the binary splitters enable cells to be equally split in all the splitter channels (para. [0052]). The binary splitters employed by Collins are structurally the same as the bifurcating from the sheath inlet port
It would have been prima facie obvious to one of ordinary skill in the art to use Collins’ teaching of binary splitters in Hou et al.’s microfluidic device because binary splitters enable cells to be equally split in all the splitter channels. Furthermore, one of ordinary skill would understand that using binary splitters would enable the fluid to be split in the microfluidic device. This method of improving Hou et al.’s microfluidic device was within the ability of one ordinary skill in the art based on the teachings of Collins. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Hou et al. and Collins to obtain the claimed invention as specified in claim 8.
Claims 9-13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. (already referenced).
Regarding claim 9, Hou et al. teaches the microfluidic device of claim 1, but fails to teach that the sample inlet channels all have the same dimension; however, sample inlet channels having the same dimension would be amount to mere duplication of parts, as duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 VI). Making multiple sample inlet channels with the same dimension would amount to duplicating the inlet channels, as one of ordinary skill in the art would understand duplicating the inlet channels would lead to each channel possessing the same dimension. Therefore, the claim is prima facie obvious.
Regarding claim 10, Hou et al. teaches the microfluidic device of claim 1, but fails to teach that the sample inlet channels are defined as having a width of 50 μm to 1000 μm. However, Hou et al. teaches the channel width for the inlet at a range of (150-500 μm) for the sheath/sample (para. [0139]). It has been established that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP § 2144.05 I). The claimed sample inlet channel width range (50-1000 μm) overlaps with the prior art’s (150-500 μm). Thus, the claim is prima facie obvious.
Regarding claim 11, Hou et al. teaches the microfluidic device of claim 1, but fails to teach that the sheath inlet channels are defined as having a width of 50 μm to 1000 μm. However, Hou et al. teaches the channel width for the inlet at a range of (150-500 μm) for the sheath/sample (para. [0139]). It has been established that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP § 2144.05 I). The claimed sheath inlet channel width range (50-1000 μm) overlaps with the prior art’s (150-500 μm). Thus, the claim is prima facie obvious.
Regarding claim 12, Hou et al. teaches the microfluidic device of claim 1, but fails to teach that the semi-spiral shaped channels have a length of 5 mm to 35 mm (3.5 cm). Hou et al. teaches that “spiral-shaped channel may be defined as having a length ranging from 3 cm to 10 cm” (para. [0091]). It has been established that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP § 2144.05 I). The claimed semi-spiral shaped channel length range (5 mm to 35 mm (3.5 cm)) overlaps with the prior art’s (3 cm to 10 cm). Thus, the claim is prima facie obvious.
Regarding claim 13, Hou et al. teaches the microfluidic device of claim 1, but fails to teach that the first outlet channel is defined as having a width of 25 μm to 500 μm. Hou et al. teaches that the first outlet channel may have a width ranging from 20 μm to 100 μm (para. [0098]). It has been established that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP § 2144.05 I). The claimed first outlet channel width (25 μm to 500 μm) overlaps with the prior art’s (20 μm to 100 μm). Thus, the claim is prima facie obvious.
Regarding claim 15, Hou et al. teaches the microfluidic device of claim 14, but fails to teach the second outlet channel defined as a having a width of 800 μm to 3000 μm. Hou et al. teaches “other outlet channels then have a width that adds up to 500 μm to 3000 μm” (para. [0098]). It has been established that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP § 2144.05 I). The claimed second outlet channel width range (800 to 3000 μm) overlaps with the prior art’s (500 μm to 3000 μm). Thus, the claim is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
Prosecution Insights