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 with traverse of in the reply filed on 10/15/2025 is acknowledged. The traversal is on the ground(s) that amended claim 1 and 24 now additionally requires a technical feature of “the surface area to footprint ratio being at least 1.6,” which Bornstein allegedly fails to teach (pp. 6-7 of Remarks) and thus is a special technical feature. This is not found persuasive because Group I (claims 1-2, 5-6, 8-14, 16-20 and 22-23) and Group II (claims 24-25) still lacks unit of invention in view of Spero et al. (WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1).
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a kit for forming a microfluidic chip, the kit comprising: a substrate having a surface with topographical relief bearing at least 4 relief patterned regions, each defining a respective interface-pinning reaction vessel covering a footprint area of 0.5 to 15 cm2 with a surface area of at least 1.6 times the footprint area; and a part with a covering surface dimensioned for sealing against the substrate to enclose a single flow-through chamber that includes the vessels, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Spero et al. (WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1). Spero teaches a kit for forming a microfluidic chip (Fig. 1A, the chip includes 100 and 200, specifically the 100 shown in Fig. 23 is used; in addition Fig. 2B, 100 includes 150 140, 110, 130), the kit comprising:
a substrate (110) having a surface with topographical relief bearing at least 4 relief patterned regions (4 of the reaction chambers 105 in Fig. 23B), each defining a respective interface-pinning reaction vessel (chamber 105, which has an array of microposts 122) covering a footprint area of 0.5 to 15 cm2 (para. 0099, the reaction chamber 105 can be any area. Additionally, Figs. 12-14, 23B and para. 0085 teaches chamber 105 are made in a 6-inch or 12-inch wafer, which has an area of 182cm2 and 730 cm2, respectively, and thus has sufficient area to make the modular active surface device 100 shown in Fig. 23B with reactor chambers 105 with area ranges in 0.5 to 15 cm2. If it is determined this limitation is not anticipated by Spero, then the examiner put forth the following rejection. Spero teaches wherein the area of reaction chamber 105 is a result-effective variable. Specifically, Spero teaches that the area of reaction 105 is depends on the end user’s requirement (para. 0099). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the reaction chambers with an area of 0.5 to 15 cm2) with a surface area of at least 1.6 times the footprint area (para. 0061, the micropost array has microposts of 4 mm-diameter, a controlled density of 105 microposts/cm2 with 30 x higher or 100 x lower being reasonable range. Paras. 0011 and 0042, each micropost can have height between 1-100 mm, and thus the surface area is at least 1.6 times. For example, for a micropost of 4 mm in diameter and 100 mm in height, its surface area is 1.27x 10-5 cm (which means 1.27x 10-5 cm surface area per micropost), and with a controlled density of 2 x 105 microposts/cm2 (which is 2 x 105 microposts/ footprint area in cm2), then that would yield 2.5 times of surface area per footprint area); and
a part (150) with a covering surface dimensioned for sealing against the substrate.
Spero teaches a microfluidic device (100 and 200)(Figs. 1A, 23B) for processing biological materials (0004) for a variety of applications (paras. 0051 and 0105). Spero further teaches the size and features of modular active surface devices 100 (which comprises of 110)(Fig. 2B) is based on the requirements of the end user (para. 0099). Spero teaches the device can be used for assaying large amounts of biological material in a multiplexed format (para. 0068).
Spero teaches the substrate (110) has isolated reaction chambers 105 (vessels) instead of a single flow-through chamber that includes the vessels (reaction chambers 105)(Fig. 23B), and thus Spero fails to teach the part (150) with a covering surface dimensioned for sealing against the substrate to enclose a single flow-through chamber that includes the vessels.
However, In addition, Fuchs teaches a microfluidic device for analyzing biological samples (Fuchs, abstract) in a multiplexed format. Fuchs teaches the device comprises a single flow-through chamber including an inlet that is connected to a plurality of reaction channels (reaction vessels), which are connected to an outlet (Fig. 1C, para. 0055). Fuchs teaches device allows for the multiplexed format such that a single sample can enter device through the inlet and be assayed in different conditions in different reaction channels.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the isolated reaction chambers 105 taught by Spero to include a single flow-through chamber that includes an inlet that is connected to the reaction vessels (reaction chambers 105), which are connected an outlet as taught by Fuchs in order to perform multiplexed assays using a single sample with a reasonable expectation of success (Fuchs, abstract and para. 0055) (MPEP 2143)(I)(G).
The teachings of Spero as modified by Fuchs would yield the part (150) with a covering surface dimensioned for sealing against the substrate to enclose a single flow-through chamber that includes the vessels.
Therefore, the common feature between the groups does not provide a contribution over the prior art, and, thus cannot be a special technical feature. Therefore, Groups I and II do not relate to a single inventive concept under PCT Rule 13.1.
The requirement is still deemed proper and is therefore made FINAL.
Claims 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/5/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/13/2022 and 04/25/2024 are being considered by the examiner.
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 1-2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. US 9291567 B2 in view of Spero (WO 2018236833 A1).
Regarding claim 1, claim 8 of U.S. Patent No. US 9291567 B2 claims a kit for forming a microfluidic chip, the kit (microfluidic device) comprising:
a substrate (polymeric substrate, claim 1, lines 1-2) having a surface with topographical relief bearing at least 4 relief patterned regions (the portion of the substrate with the nano-scale elements divided into 4 regions)(claim 1, line 3, an ordered array of nano-scale elements on the substrate), each defining a respective interface-pinning reaction vessel (the portion of the array of nanoscale elements corresponds to each region) covering a footprint area with a surface area of at least 1.6 times the footprint area (claim 1, nano-scale element has a cross-sectional dimension in a range from 10 – 1000 nm, and the cross-sectional dimension to spacing distance ratio is greater than 0.2; claim 8, lines 4-5, aspect ratio of nano-scale element is in a range of 10:1 to 1:10 )(For example, a nano-scale element that is a square prism, with a cross-sectional dimension of 1000 nm, a height of 10 mm, and a cross-sectional dimension to spacing distance ratio of 1 would yield a surface area of over 10 times the footprint area); and
claim 8 of U.S. Patent No. US 9291567 B2 further claims the substrate includes a single flow-through chamber (substrate patterned with one or more micro-scale channels in fluid communication with one or more microfluidic chambers)(claim 1, lines 2-4) that includes the vessels (claim 1, lines 4-5).
claim 8 of U.S. Patent No. US 9291567 B2 does not explicitly claim the device comprising a part with a covering surface dimensioned for sealing against the substrate dimensioned for sealing against the substrate to enclose the single flow-through chamber that includes the vessels. In addition, claim 8 of U.S. Patent No. US 9291567 B2 does not explicitly claim the each region has a footprint area of 0.5 to 15 cm2.
However, Spero teaches microfluidic chip with a substrate (110) including pillars (micropost)(para. 0056). Spero further teaches the chip comprises a part (substrate 150) with a covering surface dimensioned for sealing against the substrate dimensioned for sealing against the substrate (Figs. 2A, 2B) to enclose a single flow-through chamber that includes the vessels (Fig. 1A). Spero further teaches substrate 150 work in combination with substrate 110 to form reaction chamber 105 and to protect microposts 122 (pillars) (para. 0068).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic device claimed by claim 8 of U.S. Patent No. US 9291567 B2 to include a part with a covering surface dimensioned for sealing against the substrate to enclose the single flow-through chamber that includes the vessels as taught by Spero in order to have the part to form a reaction chamber and protect the pillars with a reasonable expectation of success (Spero, Fig. 1A, 2A and 2B and para. 0068) (MPEP 2143)(I)(G).
In addition, Spero teaches that area of reaction chamber 105 (where the microposts are) can be of any size based on the end user requirement (Spero, para. 0099).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portion of the substrate with the nano-scale elements claimed by claim 8 of U.S. Patent No. US 9291567 B2 to have an area such that the footprint area of each region is within 0.5 to 15 cm2 in order to meet the end user requirement with a reasonable expectation of success (Spero, para. 0099)(MPEP 2143)(I)(G).
Regarding claim 2, modified claim 8 of U.S. Patent No. US 9291567 B2 claims all of the elements of the current invention as stated above with respect to claim 1.
Modified claim 8 of U.S. Patent No. US 9291567 B2 fails to explicitly claim wherein each region's footprint extends at least 0.1 mm, and at most 50 mm, in both each of two normal planar directions.
However, Spero teaches that the size and features of modular active surface devices 100 and the area of reaction chamber 105 (where the microposts are) can be of any size (dimension, width and length) based on the end user requirement.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portion of the substrate with the nano-scale elements claimed by claim 8 of U.S. Patent No. US 9291567 B2 to have an dimension such that after dividing into 4 region, each region has an length and width to be at least 0.1 mm, and at most 50 mm and be within the footprint area limitation of claim 1 in order to meet the end user requirement with a reasonable expectation of success (Spero, para. 0099)(MPEP 2143)(I)(G).
Regarding claim 5, modified claim 8 of U.S. Patent No. US 9291567 B2 claims all of the elements of the current invention as stated above with respect to claim 1. Modified claim 8 of U.S. Patent No. US 9291567 B2 further claims each region has a surface area that is 2-50 times its footprint area (see claim 1 above).
Claims 1, 2 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 17265292 (claim set of 09/24/2025) in view of Spero (WO 2018236833 A1).
Regarding claim 1, Claim 15 of copending Application No. 17265292 claims a kit for forming a microfluidic chip (microfluid device), the kit comprising:
a substrate (microfluidic chip, line 2) having a surface with topographical relief bearing at least 4 relief patterned regions (line 3, “at least one row of at least 3 pillars”, and thus there can be 4 rows, and each row is a region), each defining a respective interface-pinning reaction vessel (each row of pillars) covering a footprint area of 0.5 to 15 cm2 (50 pillars of 1000 um in diameter with means separations of 1 um would give 5 cm x 0.1 cm, 0.5 cm2 footprint area) with a surface area of at least 1.6 times the footprint area (with aspect ratio of 2:1, a pillar of 1000 mm in diameter will be 2000 mm in height, and thus the surface area of 50 pillars is 0.0707 cm2 / pillar x 50 pillars = 3.15 cm2, which gives a 7.3 surface area to footprint area ratio); and
Claim 15 of copending Application No. 17265292 further claims a the microfluidic chip includes a single flow-through chamber (microfluidic chamber)(line 2) that includes the vessels (each row of pillars) (lines 2-3).
Claim 15 of copending Application No. 17265292 does not explicitly claim a part with a covering surface dimensioned for sealing against the substrate dimensioned for sealing against the substrate to enclose the single flow-through chamber that includes the vessels.
However, Spero teaches microfluidic chip with a substrate (110) including pillars (micropost)(para. 0056). Spero further teaches the chip comprises a part (substrate 150) with a covering surface dimensioned for sealing against the substrate dimensioned for sealing against the substrate (Figs. 2A, 2B) to enclose a single flow-through chamber that includes the vessels (Fig. 1A). Spero further teaches substrate 150 work in combination with substrate 110 to form reaction chamber 105 and to protect microposts 122 (pillars) (para. 0068).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic device claimed by claim 15 of copending Application No. 17265292 to include a part with a covering surface dimensioned for sealing against the substrate to enclose the single flow-through chamber that includes the vessels as taught by Spero in order to have the part to form a reaction chamber and protect the pillars with a reasonable expectation of success (Spero, Fig. 1A, 2A and 2B) (MPEP 2143)(I)(G).
Regarding claim 2, modified claim 15 of copending Application No. 17265292 claims all of the elements of the current invention as stated above with respect to claim 1. Modified claim 15 of copending Application No. 17265292 further claims wherein each region's footprint extends at least 0.1 mm, and at most 50 mm, in both each of two normal planar directions (see claim 1 above, a footprint of 5 cm x 0.1 cm which is 50 mm x 1 mm).
Regarding claim 5, modified claim 15 of copending Application No. 17265292 claims all of the elements of the current invention as stated above with respect to claim 1. Modified claim 15 of copending Application No. 17265292 further claims each region has a surface area that is 2-50 times its footprint area (see claim 1 above).
This is a provisional nonstatutory double patenting rejection.
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 8-14, 20 and 22-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "a chip" in line 2. It is unclear whether it is referring to the “microfluidic chip” recites in the preamble in claim 1 or a different chip. It is also unclear what constitutes the chip. For the purpose of examination, it is being interpreted as the same chip as the microfluidic chip in the preamble (para. 0020 in the Specification, “the chamber may have at least one ingress from a microfluidic network of the chip formed by the kit”), and the chip comprises the substrate, the part, the chamber (also referred to as a “single flow-through” chamber in claim 1) and a microfluidic network, wherein the chamber is formed by the part sealing against the substrate (claim 1).
Claims 9-13 are indefinite because of their dependency on claim 8.
Claim 12 recites the limitation "the relief pattern" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is being interpreted as a relief pattern.
Claim 14 recites the limitation "a chip" in line 2. It is unclear whether it is referring to the “microfluidic chip” recites in the preamble in claim 1 or a different chip. For the purpose of examination, it is being interpreted as the same chip as the microfluidic chip in the preamble.
Claim 20 recites the limitation "a chip" in line 2. It is unclear whether it is referring to the “microfluidic chip” recites in the preamble in claim 1 or a different chip. For the purpose of examination, it is being interpreted as the same chip as the microfluidic chip in the preamble. Claim 20 further recites the limitation "the cover" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is being interpreted as “the part with a covering surface” recites in claim 1.
Claim 22 is indefinite because of its dependency on claim 20.
Claim 23 recites “The kit according to claim 1 assembled to form a chip” in line 1.It is unclear whether it is referring to the “microfluidic chip” recites in the preamble in claim 1 or a different chip. It is also unclear what constitutes the chip. Clarification is requested. For the purpose of examination, it is being interpreted as the same chip as the microfluidic chip in the preamble.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-6 and 23 rejected under 35 U.S.C. 103 as being unpatentable over Spero et al. ((WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1).
Regarding claim 1, Spero teaches a kit for forming a microfluidic chip (Fig. 1A, the chip includes 100 and 200, specifically the 100 shown in Fig. 23 is used; in addition Fig. 2B, 100 includes 150 140, 110, 130), the kit comprising:
a substrate (110) having a surface with topographical relief bearing at least 4 relief patterned regions (4 of the reaction chambers 105 in Fig. 23B), each defining a respective interface-pinning reaction vessel (reaction chamber 105, which has an array of microposts 122)(para. 0056) covering a footprint area of 0.5 to 15 cm2 (para. 0099, the reaction chamber 105 can be any area. Additionally, Figs. 12-14, 23B and para. 0085 teaches chamber 105 are made in a 6-inch or 12-inch wafer, which has an area of 182cm2 and 730 cm2, respectively, and thus has sufficient area to make the modular active surface device 100 shown in Fig. 23B with reactor chambers 105 with area ranges in 0.5 to 15 cm2. If it is determined this limitation is not anticipated by Spero, then the examiner put forth the following rejection. Spero teaches wherein the area of reaction chamber 105 is a result-effective variable. Specifically, Spero teaches that the area of reaction 105 is depends on the end user’s requirement in para. 0099. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the reaction chambers with an area of 0.5 to 15 cm2) with a surface area of at least 1.6 times the footprint area (para. 0061, the micropost array has microposts of 4 mm-diameter, a controlled density of 105 microposts/cm2 with 30 x higher or 100 x lower being reasonable range, and paras. 0011 and 0042, each micropost can have height between 1-100 mm; therefore, the surface area is at least 1.6 times. For example, for a micropost of 4 mm in diameter and 100 mm in height, its surface area is 1.27x 10-5 cm (which means 1.27x 10-5 cm surface area per micropost), and with a controlled density of 2 x 105 microposts/cm2 (which is 2 x 105 microposts/ footprint area in cm2), then that would yield 2.5 times of surface area per footprint area); and
a part (150) with a covering surface dimensioned for sealing against the substrate (110)(Figs. 2A and 2B).
Spero teaches a microfluidic device (100 and 200)(Figs. 1A, 23B) for processing biological materials (0004) for a variety of applications (paras. 0051 and 0105). Spero further teaches the size and features of modular active surface devices 100 (which comprises of 110)(Fig. 2B) is based on the requirements of the end user (para. 0099). Spero teaches the device can be used for assaying large amounts of biological material in a multiplexed format (para. 0068).
Spero teaches the substrate (110) has isolated reaction chambers 105 (vessels) instead of a single flow-through chamber that includes the vessels (reaction chambers 105)(Fig. 23B), and thus Spero fails to teach the part (150) with a covering surface dimensioned for sealing against the substrate to enclose a single flow-through chamber that includes the vessels.
However, In addition, Fuchs teaches a microfluidic device for analyzing biological samples (Fuchs, abstract) in a multiplexed format. Fuchs teaches the device comprises a single flow-through chamber including an inlet that is connected to a plurality of reaction channels (reaction vessels), which are connected to an outlet (Fig. 1C, para. 0055). Fuchs teaches device allows for the multiplexed format such that a single sample can enter device through the inlet and be assayed in different conditions in different reaction channels.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the isolated reaction chambers 105 taught by Spero to include a single flow-through chamber that includes an inlet that is connected to the reaction vessels (reaction chambers 105), which are connected an outlet as taught by Fuchs in order to perform multiplexed assays using a single sample with a reasonable expectation of success (Fuchs, abstract and para. 0055) (MPEP 2143)(I)(G).
The teachings of Spero as modified by Fuchs would yield the part (150) with a covering surface dimensioned for sealing against the substrate to enclose a single flow-through chamber that includes the vessels.
Regarding claim 2, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Spero fails to explicitly teach wherein each region's footprint (the area of reaction chamber 105) extends at least 0.1 mm, and at most 50 mm, in both each of two normal planar directions.
However Spero teaches wherein the area (and thus the length and width) of reaction chamber 105 a result-effective variable. Specifically, Spero teaches that the area (length and width) of reaction 105 is depends on the end user’s requirement (para. 0099). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the reaction chambers with an length and width to be at least 0.1 mm, and at most 50 mm and be within the area limitation of claim 1.
Regarding claim 5, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Spero further teaches each region (reaction chamber 105, which has an array of microposts) has a surface area that is 2-50 times its footprint area (para. 0061, the micropost array has microposts of 4 mm-diameter, a controlled density of 105 microposts/cm2 with 30 x higher or 100 x lower being reasonable range; and paras. 0011 and 0042, each micropost can have height between 1-100 mm, and thus the surface area is 2-50 times its footprint area. For example, for a micropost of 4 mm in diameter and 100 mm in height, its surface area is 1.27x 10-5 cm (which means 1.27x 10-5 cm surface area per micropost), and with a controlled density of 2 x 105 microposts/cm2 (which is 2 x 105 microposts/ footprint area in cm2), then that would yield 2.5 times of surface area per footprint area).
Regarding claim 6, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Spero further teaches each region (chamber 105) is separated from each neighbouring region by segments of the surface (the regions between reaction chambers 105) that have a ratio of surface area to footprint that is no more than 1.1 (the regions between reaction chambers 105 do not have microposts and thus the ratio is closer to 1)(Fig. 23B).
Spero does not explicitly teach each segment separates the neighbouring regions by a distance that is greater than at least one of: 0.1 mm; or 5% of a mean of the extents of the neighbouring regions in the planar directions.
However Spero teaches wherein the dimensions of the regions between reaction chambers 105 is a result-effective variable. Specifically, Spero teaches that the size and features of modular active surface devices 100 (the regions between reaction chambers 105 is feature of 100) depends on the end user’s requirement (para. 0099 and Fig. 23B). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the dimensions of the regions between reaction chambers 105 between the reaction chamber to be greater than at least one of: 0.1 mm; or 5% of a mean of the extents of the neighbouring regions in the planar directions.
Regarding claim 23, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Spero further teaches the kit according to claim 1 assembled to form a chip (Spero, Fig. 2A -2B)(See also the 35 U.S.C. 112(b) section).
Claims 8-13, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Spero et al. (WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1) as applied to claim 1 above, and further in view of Lawi et al. (“A Microfluidic Cartridge System for Multiplexed Clinical Analysis.” JALA Charlottes Va. 2009 December 1; 14(6): 407–412).
Regarding claim 8, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Spero further teaches wherein the chamber (modified Spero has a single flow-through chamber that includes an inlet that is connected to the reaction chambers 105, which are connected an outlet) has at least one ingress (fluid ports 112, in modified Spero, the inlet is connected to each of the reaction chamber 105 through its fluid port 112) from a microfluidic network (212) of a chip (cartridge 200 and modular active surface devices 100)(Fig. 1A) that includes the substrate (110) and the part (150)(Fig. 1A, 2B, modular active surface devices 100 is configured to be integrated into fluidic cartridge 200)
Spero further teaches cartridge 200 can be of different configurations (Figs. 20, 21 and paras. 0099-0100); however, modified Spero does not explicitly teaches the microfluidic network comprising at least two microfluidic channels coupling two different reservoirs with the ingress.
However, Lawi teaches a microfluidic cartridge for performing multiplexed assays. Lawi further teaches the cartridges comprises a chamber (fluid handling component, FHC) has at least one ingress (reaction chamber valve ports, Fig. 3) from a microfluidic network of a chip (FHC and reagent storage component, RSC), the microfluidic network comprising at least two microfluidic channels (the channel that connects the reservoir containing the sample to each of the reaction chamber valve port in the FHC and the channel that connects the reservoir containing the substrate reagent TMB to each of the reaction chamber valve port in the FHC) coupling two different reservoirs (two of the reservoirs in the RSC- the reservoir containing the sample and the reservoir containing the substrate reagent, Fig. 3 and p. 2 under “Cartridge System”) with the ingress (interpreted as the at least one ingress)(reaction chamber valve ports in the fluid handling component, Fig. 3). Lawi teaches one of the reservoirs for storing a sample and one is for reagent substrate (p.2, “Cartridge System”) and consequently providing the sample and reagent to the reaction chamber from the reaction chamber valve ports (ingresses) for the multiplexed assays (Figs. 3-4 and p. 2, “Fluid Handling”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified 212 (microfluidic network) of the fluidic cartridge 200 taught by Spero to include at least two microfluidic channels coupling two different reservoirs with the reaction chamber valve ports (the least one ingress/ fluid ports 112) taught by Lawi in order to provide the sample and reagent necessary for the multiplexed assays with a reasonable expectation of success (Lawi, Figs 3-4, and p.2, “Cartridge System” and “Fluid Handling”) (MPEP 2143)(I)(G).
Regarding claim 9, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 8. Modified Spero further teaches wherein the microfluidic network comprises two subnetworks (one subnetwork comprising the channel that connects the reservoir containing the sample to the fluid port 112 of each of the chambers 105; and the second subnetwork comprising the channel that connects the reservoir containing the substrate reagent to fluid port 112 of each of the chambers 105)(see claim 8 and also Lawi, Fig. 3 and p. 2 under “Cartridge System”): a marking network equipped for performing a marking process within the chamber (interpreted as a functional limitation, the channel that connects the reservoir containing the substrate reagent TMB is structurally capable of performing a marking process); and a prep network equipped for treating a test sample (interpreted as a functional limitation, the channel that connects the reservoir containing the sample is structurally capable of treating a test sample).
Regarding claim 10, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 8. Spero further teaches wherein the part (150) is a first film (PET substrate)(para. 0068), and the covering surface is a side of the first film (the bottom side of 150 is the covering surface, Fig. 2B).
Regarding claim 11, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 10. Modified Spero further teaches wherein
Regarding claim 12, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 10.
Modified Spero does not explicitly teach wherein the relief pattern (interpreted “a relief pattern” as discussed in 35 U.S.C. 112 (b) section above) defines at least one microfluidic blister for retaining a liquid.
However, Spero teaches the modular active surface device 100 can be delivered to the user (to be integrated with cartridge 200, para. 0100) and then surface modifications can be performed in the field, and blister packs are used to store and to release a surface modification chemical to achieve modification of any surface in reaction chambers 105 (paras. 0105-0106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have the chip (cartridge 200 and device 100) to include a relief pattern that defines at least one microfluidic blister for retaining a liquid in order to release a surface modification chemical to achieve surface modification of any surface in reaction chambers 105 with a reasonable expectation of success (Spero, paras. 0105-0106) (MPEP 2143)(I)(G).
Regarding claim 13, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 10. Modified Spero further teaches wherein the substrate (110) is a second film (Fig. 2B); the kit further comprises a third film (140); and at least one of the first, second or third films, has at least one through-bore (para. 0053, substrate 110 has fluid ports 112) via for coupling two microfluidic networks when stacked (Figs. 1A, 2B, para. 0055, and also see above).
Regarding claim 16, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Spero fails to teach the kit further comprising supplies of at least 3 probes.
Modified Spero teaches a modular microfluidic device for multiplex assays (para. 0068) with eight reaction chambers 105 (Fig. 23B). Spero further teaches any surface in reaction chambers 105, including the microposts 122, can be modified to promote binding of a target analyte or modified like a microarray (para. 0105). Furthermore Lawi teaches a microfluidic device for multiplex assays with six reaction chambers (Lawi, Fig. 3). Lawi further teaches a surfaces in the reaction chambers precoated with probes (myoglobin protein, RNA, BSA) to perform multiplex assay for detecting different analytes (Lawi, p. 3 “Fluid Distribution Component”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surface of each of the chamber 105 taught by Spero with a probe taught by Lawi in order to perform multiplex assays with a reasonable expectation of success (Spero, para. 0068 and 0121 and Lawi, Fig. 3 and p. 3 “Fluid Distribution Component”) (MPEP 2143)(I)(G).
The teachings of modified Spero would yield the kit further comprising supplies of at least 3 probes, with each probes functionalizing to one of the reaction chamber 105.
Regarding claim 17, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 16. Modified Spero further teaches wherein the supplies are provided by functionalizing each of the vessels with a respective one and only one of the at least 3 probes (see claim 16 above).
Regarding claim 20, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Spero fails to the kit further comprising at least one marking liquid the marking liquid comprising one or more of: a developer; a conjugated detection antibody with a target-specific binding moiety; a wash buffer; a hybridization solution; formaldehyde; and a PCR product contained within a microfluidic chamber of a chip formed with at least the substrate and the cover.
Spero teaches a microfluidic device (100 and 200) for processing biological materials (para. 0003). Spero teaches the device can be used for a variety of applications (paras. 0050 and 0105), including performing assays in a multiplexed format (para. 0068). Spero teaches the device comprises modular active surface device 100, which includes a substrate (110) and a cover (150); wherein the device 100 is integrated into a chip (cartridge 200 and device 100)(Fig. 1A, 2B and para. 0010). Spero further teaches cartridge 200 can be of different configurations (Figs. 20, 21 and paras. 0099-0100). Spero further teaches liquid and pellet reagents and reagent in blister pack can be provided with device 100 (paras. 0106-0109)
Modified Spero does not disclose what the reagents are, and thus fails to teach the kit further comprising at least one marking liquid the marking liquid comprising one or more of: a developer; a conjugated detection antibody with a target-specific binding moiety; a wash buffer; a hybridization solution; formaldehyde; and a PCR product contained within a microfluidic chamber of a chip formed with at least the substrate and the cover.
However, Lawi teaches a microfluidic cartridge for performing multiplexed assays (Abstract). Lawi further teaches the cartridges comprises the fluid handing component FHC that includes a and a cover (Fig. 3 and “Fluid Distribution Component”); wherein the FHC is combined with a reagent storage component RSC (microfluidic chamber) into a cartridge (chip)(p. 2, “System Overview”). Lawi teaches the RSC (microfluidic chamber) includes individual reagent compartments (Fig. 3). Lawi further the cartridge comprising at least one marking liquid the marking liquid comprising a developer (TMB); a conjugated detection antibody with a target-specific binding moiety (HRP-antibody or oligonucleotide probe) and a wash buffer (p. 2, Cartridge System and Electrochemical Sensor and Detection Mechanism); contained within a microfluidic chamber (RSC) of a chip (cartridge) formed with at least the substrate and the cover (FHC).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cartridge 200 (of the chip) taught by Spero to include a microfluidic chamber with reagent compartments to hold marking liquid including a developer (TMB), a conjugated detection antibody with a target-specific binding moiety (HRP-antibody or oligonucleotide probe), a wash buffer as taught by to Lawi in order to perform multiplex assays with a reasonable expectation of success (Lawi, abstract) (MPEP 2143)(I)(G).
The teaching of modified Spero would yield the kit further comprising at least one marking liquid the marking liquid comprising one or more of: a developer; a conjugated detection antibody with a target-specific binding moiety; a wash buffer; a hybridization solution; formaldehyde; and a PCR product contained within a microfluidic chamber (the microfluidic chamber with reagent compartment taught by Lawi) of a chip formed with at least the substrate and the cover (the chip comprises 100 and 200 of Spero).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Spero et al. (WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1) as applied to claim 1 above, and further in view of Schaff et al. (US 10197480 B2).
Regarding claim 14, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 1. Spero further teaches wherein at least one of the substrate (110) and the part (150) is transparent to an inspection wavelength (para. 0011, active surface layer 110 is made of PDMS, which is optically transparent); a chip produced by sealing the surface (the surface of 110 containing microposts) and the covering surface (the surface of the part)(Fig. 2A and 2B) permits inspection of the vessels through the transparent material (para. 0065).
Spero teaches the device is configured for optically interacting external light source and transparency is a determining characteristic of selection of material (para. 0006 and 0065). Modified Spero does not explicitly the transparent material is sealed to a material that is reflective or opaque to the inspection wavelength, to improve imaging of the vessels (reaction chambers 105).
Schaff teaches microfluidic cartridges. Schaff teaches a lower element of the cartridge is opaque and an upper element and side elements of the cartridge are transparent such that illumination from a side of the cartridge causes light to scattering off sample and enhances contrast (a transparent material is sealed to a material that is reflective or opaque to the inspection wavelength) (Schaff, claim 35).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified substrate 150 taught by Spero with a material that is reflective or opaque to the inspection wavelength in order to enhances contrast with a reasonable expectation of success (Schaff, claim 35) (MPEP 2143)(I)(G).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Spero et al. (WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1) and further in view of Lawi et al. (“A Microfluidic Cartridge System for Multiplexed Clinical Analysis.” JALA Charlottes Va. 2009 December 1; 14(6): 407–412) as applied to claim 16 above, and further in view of Walsh et al. (“Microfluidics with fluid walls.” Nature Communications Vol. 8, Article number 81, 2017.)
Regarding claim 19, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 16. Spero further teaches wherein the supply is provided, carried by a liquid in a fluid-tight container (blister pack)(para. 0106).
Modified Spero further teaches any surface in reaction chambers 105 can be modified with protein or DNA (biomolecule) probes to promote binding of a target analyte (Spero, para. 0105 and Lawi, p. 3 “Fluid Distribution Component”). Spero teaches surface modification is homogeneous (Spero, para. 0105).
Spero teaches the blister pack is used to release a surface modification chemical (para. 0106) to modify surfaces of reaction chamber 105 (para. 0105), but does not specify a fluid flow control method use for releasing the chemical, nor the property or volume of the chemical that would allow for spreading the chemical across and sufficiently cover the reaction chamber 105 (region) in a self-limiting way, and thus does not explicitly teach the liquid (chemical) having a contact angle and viscosity allowing for spontaneous spreading of the liquid across the region, and a volume sufficient to cover the region, but insufficient volume to overcome interface pinning, whereby the liquid, if it meets any part of the region, is self-limited to substantially covering that region.
However, Walsh teaches fluid-flow-control method that utilizes interfacial forces to pin liquids to substrates to constraint a volume of liquid to specific regions (Walsh, Abstract and Introduction). Walsh further teaches interfacial pinning is dependent fluid volume, contact angle and hydrodynamic resistance (which is dependent on viscosity)(Walsh, Results) .
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid flow control method taught by Spero to incorporate the use of interfacial forces as taught by Walsh in order to spread the chemical across and sufficiently cover the reaction chamber 105 in a self-limiting way to perform homogeneous surface modification with a reasonable expectation of success (Walsh, Abstract and Introduction) (MPEP 2143)(I)(G). In addition, Walsh teaches wherein the contact angle, volume and viscosity of the liquid (chemical) is a result-effective variable. Specifically, Walsh teaches interfacial pinning is dependent fluid volume, contact angle and hydrodynamic resistance (which is dependent on viscosity)(Walsh, Results). Since these particular parameters is recognized as result-effective variables (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variables can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the liquid (chemical) to have a contact angle and viscosity allowing for spontaneous spreading of the liquid across the region, and a volume sufficient to cover the region, but insufficient volume to overcome interface pinning, whereby the liquid, if it meets any part of the region, is self-limited to substantially covering that region.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Spero et al. (WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1) and further in view of Lawi et al. (“A Microfluidic Cartridge System for Multiplexed Clinical Analysis.” JALA Charlottes Va. 2009 December 1; 14(6): 407–412) as applied to claim 20 above, and further in view of Berenguel-Alonso et al. (“Rapid Prototyping of a Cyclic Olefin Copolymer Microfluidic Device for Automated Oocyte Culturing.” SLAS Technology. Volume 22, Issue 5, October 2017, Pages 507-517),
Regarding claim 22, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 20. Modified Spero further teaches the developer is 3,3',5,5'-tetramethylbenzidine (TMB, see claim 20).
Modified Spero teaches the substrate (110) is PDMS (para. 0011) and thus fails to teaches that the substrate is a cyclic olefin copolymer.
Modified Spero teaches the substrate is PDMS and thus fails to teaches that wherein the substrate is composed of a cyclic olefin copolymer. Modified Spero further fails to teach the developer is 3,3',5,5'-tetramethylbenzidine.
However, Berenguel-Alonso teaches fabricating microfluidic device using cyclic olefin copolymers (COC). Berenguel-Alonso further teaches COCs have emerges as alternative to PDMS in production of microfluidic devices because COCs has the advantage of low fabrication costs, all at the prototyping and mass production scale (Abstract, Introduction and Conclusion).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of 110 comprising PDMS with COC taught by Berenguel-Alonso in order to have low fabrication costs at the prototyping and mass production scale with a reasonable expectation of success (Berenguel-Alonso, Abstract, Introduction and Conclusion) (MPEP 2143)(I)(G).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Spero et al. ( WO 2018236833 A1) in view of Fuchs et al. (US 20120244529 A1) and further in view of Lawi et al. (“A Microfluidic Cartridge System for Multiplexed Clinical Analysis.” JALA Charlottes Va. 2009 December 1; 14(6): 407–412) as applied to claim 17 above, and further in view of Berenguel-Alonso et al. (“Rapid Prototyping of a Cyclic Olefin Copolymer Microfluidic Device for Automated Oocyte Culturing.” SLAS Technology. Volume 22, Issue 5, October 2017, Pages 507-517), further in view of Laib et al. (Immobilization of Biomolecules on Cycloolefin Polymer Supports, Anal. Chem. 2007, 79, 6264-6270), further in view of O’Neil et al. “Characterization of Activated Cyclic Olefin Copolymer: Effects of Ethylene/Norbornene Content on the Physiochemical Properties.” Analyst. 2016 November 28; 141(24): 6521–6532), and further in view of Hermanson (2013, Bioconjugate Techniques (Third Edition). Chapter 15 Immobilization of Ligands on Chromatography Supports).
Regarding claim 18, modified Spero teaches all of the elements of the current invention as stated above with respect to claim 17.
Modified Spero teaches the substrate (110) is PDMS (para. 0011) and thus fails to teaches that the substrate is composed of a cyclic olefin copolymer.
However, Berenguel-Alonso teaches fabricating microfluidic device using cyclic olefin copolymers (COC). Berenguel-Alonso further teaches COCs have emerges as alternative to PDMS in production of microfluidic devices because COCs has the advantage of low fabrication costs at the prototyping and mass production scale (Abstract, Introduction and Conclusion).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of 110 comprising PDMS with COC taught by Berenguel-Alonso in order to have low fabrication costs at the prototyping and mass production scale with a reasonable expectation of success (Berenguel-Alonso, Abstract, Introduction and Conclusion) (MPEP 2143)(I)(G).
Furthermore, modified Spero also fails to teach the functionalization is consistent with formation by oxygen plasma surface activation, reaction with cyanogen bromide, and binding of the probe.
However, modified Spero teaches any surface in reaction chambers 105, including the microposts 122, can be modified with protein or DNA (biomolecule) probes to promote binding of a target analyte (Spero, para. 0105 and Lawi, p. 3 “Fluid Distribution Component”). In addition, Laib teaches on modifying probes immobilization of biomolecules on COC surfaces. Laib further teaches COC is hydrophobic and the surface need to be activated and hydrophilized, without destroying their optical properties, by low-pressure gas plasma (e.g. O2 plasma) to introduce functional groups for immobilization of biomolecules (p. 6264 right col. to p. 6265, left col.). In Addition, O’Neil teaches O-2 plasma treatment of COC introduces hydroxyl groups to the COC surface (O’Neil, p. 9). Moreover, Hermanson teaches bioconjugation technique for covalently conjugating biomolecules to solid supports. Hermanson further teach -OH group on a support can be activated by cyanogen bromide to modified biomolecule through amine (pp. 664-666, Fig. 15.61 and 15.62 ; amine is commonly present in biomolecules, e.g., lysine in proteins and DNA oligos with an amine spacer, and commonly used for modification).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the functionalization method taught by modified Spero with a method of functionalization that is consistent with formation by oxygen plasma surface activation of COCs (Laib, p. 6264 right col. to p. 6265, left col., and O’Neil, p. 9), reaction with cyanogen bromide, and binding of the probe (Hermanson, pp. 664-666, Fig. 15.61 and 15.62) in order to modify the surfaces in reaction chambers 105 to promote binding of a target analyte without destroying COC’s optical properties with a reasonable expectation of success (Spero, para. 0105 and Lawi, p. 3 “Fluid Distribution Component”, Laib, pp. 6264-6264) (MPEP 2143)(I)(G).
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758