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 .
Claim Rejections - 35 USC § 101 and 112(b)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility. Claim 18 recites a use claim without any method steps.
Claim 18 is also 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 18 recites the use of a microfluidic device without positively reciting any method steps. Therefore, the claimed method of “using the microfluidic device” is unclear.
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 (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gong et al. (US 2003/0138941). Gong teaches a sample preparation and analysis chip. The portions of the device most relevant to the instant claims are shown in Figures 1-4 and described in Paragraphs YYY.
Regarding claims 1, 3 and 4 – As shown in Figures 1-4, Gong teaches bottom layer (substrate 36) comprising a plurality of light-transmissive wells (assay stations 26); and a top layer (sealing layer 40) comprising an injection opening (inlets 21) and a fluid distribution system, wherein said fluid distribution system comprises a plurality of distribution channels (30), wherein said injection opening (inlets 21) is in fluid connection to each of said plurality of distribution channels (30) at an inlet end of each of said plurality of distribution channels and wherein each of said plurality of distribution channels is in fluid connection to one of said plurality of light-transmissive wells (assay stations 26) at an outlet end (assay station channel 28) of each of said plurality of distribution channels. The Examiner notes that Gong teaches the channel and well features may be in either layer (36, 40) in Paragraph 0084 and recites transparent elements for the substrate (36) and cover layer (40) in Paragraphs 0120.
Regarding the limitation of “characterized in that each of said plurality of distribution channels has: essentially the same channel length between the inlet end and the outlet end; and essentially the same channel volume”. The Examiner submits that the total length for a distribution channel (channel 30 plus assay station channel 28) ending at any given pair of opposing wells (assay stations 26) that are opposite each other along the distribution channels (30) would have essentially the same channel length and volume between the inlet end (inlet 21) and the outlet (assay station channel 28) into the wells (assay stations 26).
Regarding claim 2 – The Examiner submits that a distribution channel (channel 30 plus assay station channel 28) ending at any given pair of wells (assay stations 26) that are opposite each other along the distribution channels (30) would fill the opposing wells (assay stations 26) simultaneously. The Examiner further notes that the claim as currently written does not require ALL wells of the device to be filled simultaneously. See claim one which recites a “plurality of light transmissive wells” – which can be any pair of wells (assay stations 26) along the distribution channel (30).
Regarding claims 5 and 6 – Gong further teaches a drainage system having a plurality of drainage channels (waste channels 45) connected to the plurality of wells (assay stations 26) in Figures 5A-5E and 11A-11B; and also Paragraphs 0121 and 149-0152. Gong shows the waste channels in a sublayer in Figures 6A-6G.
Inventorship
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.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (US 2003/0138941). Gong teaches every element of claim 7 except for the cross-sectional area of each of said plurality of distribution channels decreases near the outlet end. The Examiner first takes the position that the difference between the prior art and the claimed channel is a recitation of relative dimensions of the channel area and that the instant claims would not perform differently than the prior art. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In the instant case, the claimed device would not perform the function of distributing fluid differently than the prior art. The Examiner also takes the position that the difference the prior art and the claimed channel is a mere difference of shape and that the instant claims would not perform differently than the prior art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was 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 claimed container was significant.) In the instant case, the claimed device would not perform the function of distributing fluid differently than the prior art. See MPEP 2144.04, Sections IV, A and IV, B.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (US 2003/0138941) in view of Crivelli et al. (US 2017/0152081). Gong as described above teaches every element of claim 15 except for the injection tool. Crivelli teaches methods and mechanisms for delivering material from a container to a digital fluidics cartridge. The embodiment of the device most relevant to the instant claims is shown in Figures 25A-25D and described in Paragraphs 0160-0171. As shown in Figures 25A-25D, Crivelli teaches a liquid storage and delivery mechanism (2500) that includes a flow control plate (2510) having an adapter (housing 2530) for receiving a shell (2503) with a reservoir (2508) containing a reagent. The material contained in the reservoir (2508) is delivered to the cartridge (unlabeled) under the flow control plate (2510) after engagement with a piercing element (piercer 2518) to pierce the closure lid (2504) of the reservoir and release the liquid. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the housing (2530) from Crivelli with the device of Gong. One of ordinary skill in the art at the time would add the housing to Gong in order to receive containers of material in the inlet port as taught by Crivelli.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (US 2003/0138941) in view of Fang et al. (US 2009/0275480). Gong as described above in Paragraphs 4-8 teaches every element of claim 16 except for the surface roughness of the well. Gong is silent as to a specific level of surface roughness. Fang teaches a device for optical assay. The optical assay is performed in the well bottom of a microwell plate. The well bottom has a preferred surface roughness of 1-10 nm in order to provide a smooth, flat surface for optical analysis of the well contents. See Paragraphs 0048-0051 directed to the properties of the substrate having the well array. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the surface roughness of the well from Fang with the device of Gong. One of ordinary skill in the art at the time would add the surface roughness of less than 10 nm to Gong in order to provide a smooth or substantially planar surface for optical analysis as taught by Fang.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al. (US 2003/0138941) in view of Childers et al. (US 2004/0219074). Gong as described above in Paragraphs 4-8 teaches every element of claims 17-20 except for the plurality of different antimicrobial drugs for determining whether the drug is effective against a bacteria. Childers teaches a test tray system for assessing the response of a biological sample to a compound or combination of compounds. The compound or combination of compounds are arranged in the wells in a factorial design in the wells of the tray in order to identify the optimal compound combination and concentrations. The tray is best shown in Figures 1-2 and described in Paragraphs 0019-0045 and 0120-0136. The tray includes a plurality of test compounds that may have a desired property. In Paragraphs 0030-0033, Childers teaches assessing the effects (if any) of test compounds including possible antimicrobial compounds on samples placed in the wells. The results in the wells are then analyzed to determine which compounds (if any) exhibit the desired effects. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the antimicrobial test compounds from Childers with the device of Gong. One of ordinary skill in the art at the time would add the antimicrobial test compounds to Gong in order to test a plurality of different microbial agents for efficacy against a bacteria sample as taught by Childers.
Allowable Subject Matter
Claims 8-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 8-14 further recite a semi-permeable membrane disposed over at least a portion of a top side of each of said plurality of distribution channels and/or at least a portion of a top side of said plurality of drainage channels and/or at least a portion of a top side of said waste well, and wherein at least a portion of an outer surface of said membrane is provided along an outer surface of said microfluidic device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden can be reached at 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 27, 2025
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798