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 .
Status of Claims
The claim set submitted on 09 JULY 2026 is acknowledged and considered. In the claim set, Claims 1, 8 and 11 are ‘Currently Amended’; Claims 2-6, 9 and 10 are ‘Cancelled’; Claims 7, 8, 11-15 are ‘Previously Presented’; Claims 16-21 are ‘New’.
Current pending claims are Claims 1, 7, 8 and 11-21 and are considered on the merits below.
Response to Amendment/Arguments
Applicant's arguments filed 09 JULY 2026 have been fully considered but they are not persuasive.
In the REMARKS filed on 09 JULY 2026, Applicant asserts, regarding Claim 1, that “neither Harrison nor Ismagilov teaches the structural groove geometry of claim 1”; “neither Harrison nor Ismagilov teaches anything analogous to the claimed “aperture having an opening corresponding with the flow path”” ; and “Harrison and Ismagilov fail to disclose the flow rate adjusting device coupled to the outlet …”.
In response to the assertion regarding the structural groove; Examiner has assert that the Ismagilov teaches all these structural features. Applicant asserts that Ismagilov does not disclose grooves extending downwardly from the planar bottom of a flow path nor is it suggested …to trap a flow diagnostic sample.
Examiner respectfully disagrees. Below annotated Figure 16 shows the “grooves extending downwardly from the planar bottom of a flow path nor is it suggested …to trap a flow diagnostic sample”.
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It can be seen from the annotated Figure 16 of ISMAGLIOV, the planar surface is the dashed line; the groove is the circular trap which extends downwardly; and it can be seen in Figure 16, the circular sample is the diagnostic sample.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that neither “Harrison nor Ismagilov teaches anything analogous to the claimed “aperture having an opening corresponding with the flow path” “ is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both the Harrison and Ismagilov references teach a micro device with all the structural features as required by the claim.
HARRISON teaches the device has flow passages in the surface of a suitable substrate and cover plate with holes .
In addition, ISMAGILOV teaches plug-fluids are introduced either through a single inlet or from multiple inlets; these inlets are considered to be apertures with a corresponding opening with the flow path.
If Applicant means the structure of the aperture is one that is describe as that in regards to Figure 10A-F and has feature of where the ‘aperture 40 according to the present invention allows light to pass through only the flow path 11 in the micro device 10, so it may be easy to observe the aggregation reaction occurring in the micro device 10. This is not in the claim language. Nor is it claimed that the aperture is placed over the flow channel as it appear in Figure 1.
The preamble of “for diagnosing a disease” is solely just that. When reading the preamble in the context of the entire claim, the recitation “for diagnosing a disease” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention' s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Nothing in the body of the kit claims are specifically directed towards diagnosing a disease.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s assertion that “Harrison and Ismagilov fail to disclose the flow rate adjusting device coupled to the outlet …”; Examiner respectfully disagrees.
Using the 112(f) interpretation, the flow rate adjusting device can be defined as a syringe pump; HARRISON and ISMAGLIOV both teach this. HARRISON also teach the linear velocity, the laminar flow rate, can be calculated with the equation of:
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, Column 22.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 103
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 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 1, 7, 8, 11, 12 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over HARRISON, US Patent 6,900,021 B1 , and further in view of ISMAGLIOV, US Patent 7,901,939 B2.
Applicant’s invention is directed towards a device, a kit.
Regarding Claim 1, the HARRISON reference discloses a kit, abstract, microfluidic device, 1-4C, for diagnosing a disease, the kit comprising: a micro device, Figure 1-4C, including a flow path through which a sample to be diagnosed can flow, Figure 4A-B, Column 9 line 39-60, flow path ; a planar surface that define a bottom of the flow path, Figure 1-4C, and a plurality of grooves on the bottom of the flow path for trapping the sample to be diagnosed, Figure 4B, reservoir 13 extends downwardly for capturing of cells, Column 9 line 39-60; an inlet through which the sample can be injected; and an outlet through which the sample can be discharged, Column 4 line 41-50, Column 7 line 17-49, Column 10 line 25-32, Column 10 line 64-Column 11 line 8; an aperture having an opening corresponding with the flow path, Column 5 line 48-67, flow passages in the surface of a suitable substrate, Example 1, cover plate with holes, Column 13 line 25-3; a flow rate adjusting device configured to adjust a flow rate of the sample flowing through the flow path of the micro device, Column 4 line 41-50; a tube connected to the inlet and configured to inject the sample into the inlet, Column 4 line 41-50, Column 7 line 17-49, Column 10 line 25-32, Column 10 line 64-Column 11 line 8; wherein each groove of the plurality of grooves is formed to have : a first cross-sectional area, which is adjacent to the flow path, Figure 1-4C, coplanar with the planar surface of the micro device, and at a top of the each groove of the plurality of grooves, Figure 1-4C; and a second cross sectional area, Figure 1-4C, bottom of flow path between weirs, which is spaced apart from the flow path at a bottom of the each groove of the plurality of grooves; Figure 1-4C.
Examiner’s Note: The language in the preamble recitations in claim(s) 1, “for diagnosing a disease” is solely in the preamble. When reading the preamble in the context of the entire claim, the recitation “for diagnosing a disease” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
The HARRISON reference discloses the claimed invention, but is silent in regards to the first and second cross-sectional areas wherein the first cross-sectional area is smaller than the second cross- sectional area.
The ISMAGLIOV reference discloses a kit for diagnosing a disease, the kit comprising: a micro device, Figure 16, Column 73 line 27-32, including:
a flow path through which a sample to be diagnosed can flow, Figure 16, Column 56 line 24-43;
a planar surface that defines a bottom of the flow path, Figure 16 (see annotated Figure 16 below);
and one or more a plurality of grooves that each extend downwardly, so as to be vertically beneath the planar surface, Figure 16, from the bottom of the flow path for trapping the sample to be diagnosed, Figure 16, Column 56 line 24-43, Column 12 line 26-33; [[and]]
an inlet through which the sample can be injected, Column 15 line 32-37, Figure 3, ports/channel / tube 301-306; and
an outlet through which the sample can be discharged, Column 15 line 32-37, Figure 3, ports/channel / tube 301-306;
an aperture having an opening corresponding with the flow path, Figure 16, Column 3 line 13-15;
a flow rate adjusting device configured to adjust a flow rate of the sample flowing through the flow path of the micro device, Column 15 line 28-29
a tube connected to the inlet and configured to inject the sample into the inlet, Column 15 line 32-37, Figure 3, ports/channel / tube 301-306;
wherein each groove of the plurality of grooves is formed to have:
a first cross-sectional area, which is adjacent to the flow path, coplanar with the planar surface of the micro device, and at a top of each groove of the plurality of grooves, Figure 16; and
a second cross-sectional area, which is spaced apart from the flow path and at a lower portion of the each groove of the plurality of grooves, Figure 16, it is interpreted by the Examiner that any area below the bottom of the flow path with a larger cross sectional area than the cross sectional area on the bottom of the flow path is considered to be the second cross sectional area; and wherein the first cross-sectional area is smaller than the second cross- sectional area, Figure 16, see annotated Figure below.
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The ISMAGLIOV reference discloses the claimed invention, but is silent in regards to the second cross-sectional area, which is spaced apart from the flow path and at a bottom of the at least one groove.
ISMAGLIOV rather teaches the second cross sectional area, in the expansion area of the channel, to be of a variety of shapes including but are not limited to oval, round, square, rectangular, or star-shaped, Column 56 line 24-43.
Since the different shapes of the groove is taught and suggested by ISMAGLIOV and the shape as seen in Figure 16 includes at least a first cross sectional area and a second cross section area and the shape of the groove in Figure 16 also performs the same function of trapping, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the second cross-sectional area, which is spaced apart from the flow path and at a bottom of the at least one groove since the particular shape of a product is of no patentable significance, In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947), since the function of trapping occurs with the embodiment shown in Figure 16. In addition, the shape of the groove is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the groove was significant, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
HARRISON and ISMAGLIOV references disclose the claimed invention, but is silent in regards to wherein sample is injected at a flow rate or flow through the flow path of about 15 mL/min or more.
The HARRISON reference discloses the flow rate through the device between the inlet flow paths and the main flow can be regulated, Column 6 line 18-25, by syringe pumps, Column 7 line 45-49, Column 22 line 10-42. HARRISON also teach the linear velocity, the laminar flow rate, can be calculated with the equation of:
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, Column 22.
Since HARRISON and ISMAGLIOV suggests control over the flow rate into and through the device it would be obvious to one having ordinary skill in the art before the effective filing date to modify the sample so that it is injected at a flow rate of about 15 mL/min or more to create a sufficient speed of sample through the device to trap and not clog the channel.
Additional Disclosures Included by the combination are : Claim 7: wherein the kit of claim 1, comprising a reagent configured for reacting with the sample, HARRISON Column 6 line 41-45, Column 11 line 8-23, Example II, ISMAGLIOV Column 16 line 33-38.; Claim 16: wherein the kit of claim 1, wherein each groove of the plurality of grooves is recessed solely beneath the planar surface, ISMAGLIOV Figure 16.; Claim 17: wherein the kit of claim 1, wherein the planar surface remains uninterrupted between adjacent grooves of the plurality of grooves, ISMAGLIOV Figure 16.; Claim 18: wherein the kit of claim 1, wherein each groove of the plurality of grooves opens upwardly into the flow path while remaining below the bottom of the flow path, ISMAGLIOV Figure 16.; and Claim 19: wherein the kit of claim 1, wherein: each groove of the plurality of grooves is recessed solely beneath the planar surface; the planar surface remains uninterrupted between adjacent grooves of the plurality of grooves; and each groove of the plurality of grooves opens upwardly into the flow path while remaining below the bottom of the flow path, ISMAGLIOV Figure 16.
Applicant’s invention is directed towards a method.
Regarding Claim 8, the combination of references of HARRISON and ISMAGLIOV disclose a method of using the kit according to claim 1, See Rejection to Claim 1, HARRISON abstract, Claim 1, ISMAGLIOV Column 2 line 51-67, the method comprising: injecting the sample into the micro device, HARRISON Column 10 line 66 – Column 11 line 8, ISMAGLIOV Figure 4, Column 19 line 36-67; injecting a reagent for reacting with the sample into the micro device, Column 11 line 8-34, ISMAGLIOV Figure 4, Column 19 line 36-67; locating the aperture over the micro device to observe the flow path, HARRISON Column 6 line 46-51, ISMAGLIOV Figure 16, Column 56 line 24-43; and inserting the micro device into a device for determining optical density to diagnose the disease, HARRISON Column 6 line 46-51, Column 8 line 43-44, Column 12 line 31-37, ISMAGLIOV Column 59 line 59-62.
HARRISON and ISMAGLIOV references disclose the claimed invention, but is silent in regards to wherein sample is injected at a flow rate or flow through the flow path of about 15 mL/min or more.
The HARRISON reference discloses the flow rate through the device between the inlet flow paths and the main flow can be regulated, Column 6 line 18-25, by syringe pumps, Column 7 line 45-49, Column 22 line 10-42. HARRISON also teach the linear velocity, the laminar flow rate, can be calculated with the equation of:
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, Column 22.
Since HARRISON and ISMAGLIOV suggests control over the flow rate into and through the device it would be obvious to one having ordinary skill in the art before the effective filing date to modify the sample so that it is injected at a flow rate of about 15 mL/min or more to create a sufficient speed of sample through the device to trap and not clog the channel.
Additional Disclosures Included by the combination are: Claim 11: wherein the method of claim [[9]] 8, wherein injecting the reagent into the micro device comprises injecting the reagent after the sample is trapped in the plurality of grooves, Column 11 line 8-34, Column 16 line 65-67, Claims 1 and 10 . ; Claim 12: wherein the method of claim 11, wherein the sample is a bodily fluid of a patient, HARRISON Column 14 line 5-19, ISMAGLIOV Column 43 line 29-39.; Claim 20: wherein the method of claim 8, wherein: each groove of the plurality of grooves is recessed solely beneath the planar surface; and/or the planar surface remains uninterrupted between adjacent grooves of the plurality of grooves; and/or each groove of the plurality of grooves opens upwardly into the flow path while remaining below the bottom of the flow path, ISMAGLIOV Figure 16.; and Claim 21: wherein the method of claim 8, wherein: each groove of the plurality of grooves is recessed solely beneath the planar surface; the planar surface remains uninterrupted between adjacent grooves of the plurality of grooves; and each groove of the plurality of grooves opens upwardly into the flow path while remaining below the bottom of the flow path, ISMAGLIOV Figure 16.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over HARRISON, US Patent 6,900,021 B1 , in view of ISMAGLIOV, US Patent 7,901,939 B2, and further in view of KANG, Sensors and Actuators B 107 (2005) 980–985.
Regarding Claim 13, the HARRISON and ISMAGLIOV references disclose the method of claim 11, but is silent in regards to wherein the device for determining optical density is with a micro plate reader.
THE KANG reference discloses the use of a microplate reader of a microfluidic device fabricated by micromolding with PDMS. Reactions within the microfluidic channels are observed with the microplate reader and the absorbance is measured, page 982, Section 2.4, page 983, Section 3.3. The absorbance is interpreted to be an optical density.
It would obvious to one having ordinary skill in the art before the effective filing date to modify the method of HARRISON so that the device for determining optical density is a microplate reader as taught by KANG with the advantages of enhanced throughput and efficiency, high sensitivity and precision, reducing the need to large reagent volumes and have user friendly software and data management.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over HARRISON, US Patent 6,900,021 B1, in view of ISMAGLIOV, US Patent 7,901,939 B2, and further in view of over NAM, Xenopus chip for single-egg trapping, in vitro fertilization, development, and tadpole escape, Biochemical and Biophysical Research Communications 569 (2021) 29-34.
Applicant’s invention is directed towards a method, a method of manufacturing the kit of Claim 1.
Regarding Claim 14, the HARRISON and ISMAGLIOV references disclose the kit according to claim 1, See Rejection to Claim 1 above. HARRISON generally disclose the device to be made and manufactured directly on a silicon substrate according to well established technologies, Column 6 line 56-57. 28. NAM reference discloses a method of manufacturing a kit of claim 1, that comprises a kit for diagnosing a disease, Figure 1 and 2, comprising: a micro device , Figure 1 and 2, xenopus chip, including a flow path through which a sample to be diagnosed can flow, Figure 1, best seen in (e and f) where eggs can be seen flowing, page 30-31, Section 3, in at least Figure 1, the flow path is the serpentine looking channel/passageway/conduit in the chip, and one or more grooves at a bottom portion of the flow path, Figure 1 (e and f), the more narrow channel/groove at ; and an aperture having an opening corresponding with the flow path, Figure 2 (c-g), picture through aperture on chip viewed by microscope, Section 2.7.
Examiner’s Note: The language in the preamble recitations in claim(s) 1, “for diagnosing a disease” is solely in the preamble. When reading the preamble in the context of the entire claim, the recitation “for diagnosing a disease” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
NAM discloses the method comprising manufacturing the micro device and the aperture by using a 3D printing process, Figure 1 (a-c), page 30 Section 2.1.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the well-established technologies of HARRISON with the method of manufacturing a micro device by using a 3D printing process as taught by NAM to produce various sizes of trapping sites with fine tuning of the structure over a few centimeter sized structures at 10 μm resolution, Section 1 and 2.1.
Additional Disclosure Included by the combination is: Claim 15: wherein the method of claim 14, wherein the 3D printing process comprises forming an embossed mold for the flow path and the plurality of grooves, the method further comprising attaching polydimethylsiloxane (PDMS) to the mold and then detaching the PDMS to manufacture the micro device, NAM Figure 1(a-c), page 30 Section 2.1, 2.2, 3.1. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the well-established technologies of HARRISON with the method of manufacturing a micro device by using a 3D printing process as taught by NAM to produce various sizes of trapping sites with fine tuning of the structure over a few centimeter sized structures at 10 μm resolution, Section 1 and 2.1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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