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 without traverse of group I (claims 1-11) in the reply filed on 1/22/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2023, 8/21/2024, and 1/6/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-17 are pending with claims 1-11 being examined and claims 12-17 are withdrawn.
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 1-11 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 1 recites the limitation “the bottom microchip incorporates complementary designs mirroring the wells of the top microchip” in lines 4-6. The limitation is unclear as to how the bottom chip “incorporates complementary designs” mirroring the top microchip. Specifically, the end of the claim recites that the top microchip varies in volume, but the bottom microchip has a consistent size and volume. Thus, the micro chips would not be mirroring designs of each other. The limitation is unclear as to what “complementary designs” is contributing to. Claims 2-11 are rejected by virtue of dependency on claim 1.
Claim 1 recites the limitation "the ducts” in line 6. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear. Applicant does not recite “a duct” in any of the elected claims. Thus, it is unclear as to what structure the Applicant is referring to. The Examiner interprets the duct as the wells. Claims 2-11 are rejected by virtue of dependency on claim 1.
Claim 5 contains the trademark/trade name AutoCAD. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the process of forming the microchip and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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 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.
Claim(s) 1, 4, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al (Construction and Manipulation of Serial Gradient Dilution Array on a Microfluidic Slipchip for Screening and Characterizing Inhibitors against Human Pancreatic Lipase, 2023, Biosensors, 13, 274; hereinafter “Yang”).
Regarding claim 1, Yang teaches a self-diluting microfluidic device for rapid antimicrobial susceptibility tests1 (Yang; Abstract; SlipChip microfluidic), wherein the self-diluting microfluidic device comprises a top microchip and a bottom microchip, both the top microchip and the bottom microchip have nanolitre-sized wells for self-generation of dilution gradients (Yang; Fig. 1A; page 2, para [4]; The top PDMS layer consisted of four rows of microchambers for solution injection and the bottom PDMS layer consisted of five rows of microchambers with different heights (200 µm and 600 µm) and the same diameter (2 mm) for multiple dilution), the bottom microchip incorporates complementary designs mirroring the wells of the top microchip, thereby creating fluidic channels connecting the ducts (Yang; Fig. 1B; the examiner interprets the wells that are formed when positioning the top and bottom microchip on one another as the fluidic channels), and wherein the at least two microchips remain in contact throughout entire operation (Yang; Fig. 1A; diffusion process of “slipping” the top substrate to dilute the sample), and the nanolitre-sized wells of the bottom microchip have a consistent size and volume, the nanolitre-sized wells of the top microchip have varying volumes, and well volumes decreased by half for each subsequent well2 (Yang; Fig. 1; page 2, para [4]; The top PDMS layer consisted of four rows of microchambers for solution injection and the bottom PDMS layer consisted of five rows of microchambers with different heights (200 µm and 600 µm) and the same diameter (2 mm) for multiple dilution).
1 In the preamble “a self-diluting microfluidic device for rapid antimicrobial susceptibility tests” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114.
2 The examiner notes that the claim recites “the nanolitre-sized wells of the bottom microchip have a consistent size and volume, the nanolitre-sized wells of the top microchip have varying volumes”. Yang teaches that the top layer comprises the consistent volume and size and the bottom layer has varying volume due to changes in heights. Yang teaches the claimed limitation because the top and bottom layer are based on the orientation of the device. One of ordinary skill in the art would be able to invert the microfluidic device, thus orienting the bottom layer of Yang to be the top microchip as claimed. Thus, the limitation is met and the examiner interprets the bottom layer as the top microchip and the top layer as the bottom microchip.
Regarding claim 4, Yang teaches the self-diluting microfluidic device of claim 1, wherein both the top microchip and the bottom microchip are fabricated through the following steps: creating a prototype of microchip by using AutoCAD software; converting the prototype of AutoCAD design into toolpaths for machining the microchip; using the toolpaths to drill holes at designated positions within the microchip to create inlets and outlets; employing the toolpaths to mill holes and connecting channels within the microchip, ensuring precision and consistency; and cutting out a product of microchip based on the design using the toolpaths. Claim 5 is a product-by-process limitation. Generally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Thus, the structure implied by the process steps should be considered when assessing the patentability of product- by-process claims over the prior art. MPEP § 2113(I). The process of using AutoCAD and the associated toolpaths does not structurally change the microchip, so Yang’s microchip teaches the structure implied by the fabrication process as claimed.
Regarding claim 5, Yang teaches the self-diluting microfluidic device of claim 1, wherein the self-diluting microfluidic device uses no pumps or valves to accomplish multiplexed microfluidic processes (Yang; page 10, para [1]; the entire process does not require a precise fluidic control instrument, and it can be accomplished by simple manual operations).
Regarding claim 7, Yang teaches the self-diluting microfluidic device of claim 1, wherein two fluidic channels are formed, a first fluidic channel of the two fluidic channel contains wells with a constant volume, while a second fluidic channel of the two fluidic channel contains wells with volumes decreasing consecutively by two-fold from left to right (see end of claim 1 and superscript 2).
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 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 2-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Ismagilov et al (US 20120028342 A1; hereinafter “Ismagilov”).
Regarding claim 2, Yang teaches the self-diluting microfluidic device of claim 1, with the top microchip and bottom microchip.
Yang does not teach wherein the self-diluting microfluidic device is assembled through the following steps: preparing the top microchip and the bottom microchip; applying a hydrophobic layer onto a contacting surface of the top microchip and the bottom microchip; covering the contacting surface with a medium containing 1% surfactant mixture; and clipping the top microchip and the bottom microchip together to form the self-diluting microfluidic device.
However, Ismagilov teaches an analogous art of a slip chip (Ismagilov; Abstract; Fig. 2) comprising a top microchip and a bottom microchip (Ismagilov; Fig. 1A, 1B; para [68]; The device 10 includes a base 12 and a plate 14) wherein the slip chip is assembled through the following steps: preparing the top microchip and the bottom microchip; applying a hydrophobic layer onto a contacting surface of the top microchip and the bottom microchip (Ismagilov; para [71]; The first and second surfaces 16, 20 may be made out of the same material as the base 12 and plate 14, respectively. Alternatively, the surfaces 16, 20 may be made out of any other suitable material having a low coefficient of friction and may have hydrophobic or hydrophilic properties); covering the contacting surface with a medium containing 1% surfactant mixture (Ismagilov; para [213]; Assembling the SlipChip. The SlipChip was assembled under FC-40. The bottom plate was first immersed into FC-40 in a Petri dish, with the patterns facing up); and clipping the top microchip and the bottom microchip together to form the self-diluting microfluidic device (Ismagilov; para [213]; The two plates were aligned into the position, by moving them relative to each other and then fixed by using four micro binder clips; Yang; Fig. 1A). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the bottom substrate and the top substrate of Yang to comprise the hydrophobic coating as taught by Ismagilov, because Ismagilov teaches the hydrophobic layer prevents cross-contamination (Ismagilov; para [239]). The Examiner notes that the process of “covering the contacting surface with a medium containing 1% surfactant mixture” is a product-by-process limitation. Generally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Thus, the structure implied by the process steps should be considered when assessing the patentability of product- by-process claims over the prior art. MPEP § 2113(I).
Regarding claim 3, Yang teaches the self-diluting microfluidic device of claim 2 (Yang is modified to teach the process of assembling the microchip as taught by Ismagilov), wherein the medium comprises FC-40 (Ismagilov; para [213]; Assembling the SlipChip. The SlipChip was assembled under FC-40).
Regarding claim 6, Yang teaches the self-diluting microfluidic device of claim 1, with the top microchip and the bottom microchip.
Yang does not teach wherein the top microchip and the bottom microchip are made from polymethyl methacrylate (PMMA).
However, Ismagilov teaches an analogous art of a slip chip (Ismagilov; Abstract; Fig. 2) comprising a top microchip and a bottom microchip (Ismagilov; Fig. 1A, 1B; para [68]; The device 10 includes a base 12 and a plate 14) wherein the top microchip and the bottom microchip are made from polymethyl methacrylate (PMMA) (Ismagilov; para [244]; the SlipChip can be constructed of material that is compatible with in situ diffraction, such as PDMS, PMMA, and cyclo-olefin-copolymers). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the material of the top microchip and the bottom microchip of Yang to be PMMA as taught by as this is a known and suitable substitution for the top microchip and the bottom microchip in the art, since the result would have been predictable. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Claims 8- 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yang.
Regarding claim 8, Yang teaches the self-diluting microfluidic device of claim 1, wherein the nanolitre-sized wells of the bottom microchip have dimensions of 4 mm in length, 0.5 mm in width, and 0.8 mm in height (Yang; page 4, para [2]; The top PDMS layer consists of four rows of microchambers (diameter: 2 mm, height: 200 µm)). The examiner notes that the top layer can be flipped and is interpreted as the bottom microchip as discussed above in claim 1. Yang teaches the bottom microchip comprises a length and width of 2 mm and a height of 0.2 mm. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a length, width, and height of the bottom microchip is a result effective variable that gives the well-known and expected results of serial diluting the sample (Yang; page 4-5). In the absence of a showing of unexpected results, the Office maintains the dimensions of the bottom microchip would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 9, Yang teaches the self-diluting microfluidic device of claim 1, wherein the first four of the nanolitre-sized wells of the top microchip share the same dimensions of 4 mm in length, 0.5 mm in width, but with a decreased height in a range of 0.1 mm to 10 mm (Yang; page 4, para [2]; Fig. 1B; The bottom PDMS layer consists of five rows of microchambers with different heights (200 µm and 600 µm) and the same diameter (2 mm)). The examiner notes that the bottom layer can be flipped and is interpreted as the top microchip as discussed above in claim 1. Yang teaches the top microchip comprises a length and width of 2 mm and a maximum height of 0.6 mm to 0.2 mm. Further, Yang teaches the decreasing volume as shown in Fig. 1B in the 3rd dilution. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a length, width, and height of the top microchip is a result effective variable that gives the well-known and expected results of serial diluting the sample (Yang; page 4-5). In the absence of a showing of unexpected results, the Office maintains the dimensions of the top microchip would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 10, modified Yang teaches the self-diluting microfluidic device of claim 9, wherein the fifth to seventh of the nanolitre-sized wells of the top microchip share the same dimensions of 0.5 mm in width 0.1 mm in height, but with a decreased length in a range of 0.1 mm to 2 mm (Yang; page 4, para [2]; The bottom PDMS layer consists of five rows of microchambers with different heights (200 µm and 600 µm) and the same diameter (2 mm)). The examiner notes that the bottom layer can be flipped and is interpreted as the top microchip as discussed above in claim 1. Yang teaches the top microchip comprises a length and width of 2 mm and a maximum height of 0.6 mm to 0.2 mm. Further, Yang teaches the decreasing volume as shown in latter wells having the same volume as seen in Fig. 1B in the 2nd dilution. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a length, width, and height of the top microchip is a result effective variable that gives the well-known and expected results of serial diluting the sample (Yang; page 4-5). In the absence of a showing of unexpected results, the Office maintains the dimensions of the top microchip would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 11, modified Yang teaches the self-diluting microfluidic device of claim 10, wherein the eighth well of the nanolitre-sized wells of the top microchip have dimensions of 0.5 mm in length, 0.5 mm in width and 0.05 mm in height (Yang; page 4, para [2]; The bottom PDMS layer consists of five rows of microchambers with different heights (200 µm and 600 µm) and the same diameter (2 mm)). The examiner notes that the bottom layer can be flipped and is interpreted as the top microchip as discussed above in claim 1. Yang teaches the top microchip comprises a length and width of 2 mm and a maximum height of 0.6 mm to 0.2 mm. Further, Yang teaches the decreasing volume as shown in Fig. 1B in the 1st dilution.. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a length, width, and height of the top microchip is a result effective variable that gives the well-known and expected results of serial diluting the sample (Yang; page 4-5). In the absence of a showing of unexpected results, the Office maintains the dimensions of the top microchip would have been within the skill of the art as optimization of a results effective variable.
Conclusion
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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759