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, drawn to claims 1-3, 5-9, and 11-17 in the reply filed on 09/14/2026 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers (SG10202108807U—filed 08/12/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/09/2024 has been certified and made of record.
Claim Objections
Claim 8 is objected to because of the following informalities:
“The bacterial cell counting device according claim 1” should read “The bacterial cell counting device according to claim 1”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the disclosure fails to provide sufficient structure for performing the functions “means for channel mixing” and “purging means”.
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 and 12 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 limitation “means for channel mixing” and “purging means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specifically, the specification fails to provide structure for performing the function of channel mixing and purging. Therefore, the claim (Claim 8) is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For examination purposes, if an element achieves the function of performing channel mixing, this will be seen as meeting the claim limitation. Furthermore, if an element achieves the function of performing purging, this will be seen as meeting the claim limitation.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, the pore size of 0.22 μm is unclear regarding whether the length is for a diameter or radius. For examination purposes, the pore size will be interpreted as measuring the diameter.
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 1-3, 5, 6, 9, 11, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Linfors et al. (EP 83850331 A) (referenced in IDS) in view of Holmes (US 20160011225 A1) (referenced in 892).
Regarding claim 1, Linfors et al. teaches a device used for analysis of a liquid sample, for instance at the determination of its content of microorganisms – encompasses bacterial cell counting (abstract), comprising:
An inlet for introducing a sample containing bacterial cells into the device (See annotated FIG. 2 below – element 1)
An optofluidic chip separately in fluidic communication with the inlet (measuring unit – element 12 and second filter holder – element 7) – wherein the optofluidic chip is capable of detecting a colorimetric and/or fluorescence output emitted from the bacterial cells modified by the reagents in order for the bacteria cells to be quantified relative to a control (chemiluminescence – p.2 – 3rd paragraph)
A filter strip passing through the optofluidic chip and in fluid communication with the cartridge and the inlet (Annotated FIG. 2 – element 3 (filter), the filter strip for trapping or retaining bacterial cells on its surface such that the bacterial cells can interact with the reagents as they flow through the filter strip (p. 2, line 1-35 of Linfors et al.)
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Linfors et al. fails to teach the following limitations:
At least one cartridge for containing reagents
A controller for controlling a sequential flow of reagents and sample to the filter strip via the optofluidic chip
Regarding limitations I and II, Linfors et al. teaches reagents present through 13a, 13b, 13c for performing the Luminescence analysis to be injected into the optofluidic chip but fails to teach that cartridges are specifically used. Holmes teaches a device for receiving a sample, and performing sample preparation, sample assay, and detection step (abstract), wherein cartridges (limitation I) may contain reagents for performing assays on biological samples (para. [0394]). Furthermore, Holmes teaches that the device may have one or more controllers (limitation II) to perform operations such as sample preparation, sample assaying, or sample detection (para. [0394]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Holmes’ teaching of cartridges and controllers in Linfors et al. because cartridges can hold reagents for performing assays, while controllers can perform operations such as sample preparation, assaying and detection. This method of improving Linfors et al. device was within the ability of one of ordinary skill in the art based on the teachings of Holmes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and Holmes to obtain the invention specified in claim 1.
Regarding claim 2, modified Linfors et al. teaches the bacterial cell counting device according to claim 1. Furthermore, the combination of references of claim 1 would encompass a structure of a replaceable cartridge (Holmes - “The cartridges may be insertable or removable from the device.” (para. [0394]). Therefore, the claim is prima facie obvious
Regarding claim 3, modified Linfors et al. teaches the bacterial cell counting device according to claim 1. Furthermore, the combination of references of claim would encompass a structure of a cartridge comprising aqueous nanoparticle solution (para. [1771] - probes labeled with nanoparticle light scattering labels or other nanoparticles), wherein the aqueous nanoparticle solution comprising a fluorescent nanoparticles (para. [1771]) and a surfactant (para. [1848-1849]), the nanoparticle functionalized with positively charged molecules (para. [1848-1849]). Therefore, the claim is prima facie obvious.
Regarding claim 5, modified Linfors et al. teaches bacterial cell counting device according to claim 1. Furthermore, the combination of references would encompass a second cartridge (para. [0394]), wherein the at least one cartridge comprises an aqueous nanoparticle solution (para. [1771]) comprising a wherein the aqueous nanoparticle solution comprising a fluorescent nanoparticles (para. [1771]) and a surfactant (para. [1848-1849]; and wherein the second cartridge comprises an wherein the aqueous nanoparticle solution comprising a fluorescent nanoparticles (para. [1771]) and second surfactant (para. [1848-1849]). Therefore, the claim is prima facie obvious.
Regarding claim 6, modified Linfors et al. teaches bacterial cell counting device according to claim 1, but fails to teach a washing tank, the washing tank comprising an aqueous solution for washing the filter strip with bacterial cells trapped or retained on its surface. Holmes teaches that device and/or module may permit washing, wherein the wash solution may be provided in a tip, vessel, chamber, channel tube, reservoir (para. [1241]). Holmes teaches “Wash solutions may be capable of removing unbound and/or unreacted reactants” (para. [1241])
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Holmes’s teaching of a washing tank (with a wash solution) in Linfors et al. device because the wash solution can remove unbound and/or unreacted reactants. This method of improving Linfors et al. device was within the ability of one of ordinary skill in the art based on the teachings of Holmes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and Holmes to obtain the invention specified in claim 6.
Regarding claim 9, modified Linfors et al. teaches the bacterial cell counting device according to claim 1. Linfors et al. teaches a filter strip provided as a filter tape in a filter cassette (See annotated FIG. 2 from claim 1 rejection - element 3). Furthermore, although Linfors et al. teaches that filter is windable to an adjacent unused region at a predetermined distance from a used region the windable filter would be structurally capable of performing this function, as it has been established that a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114 II). Therefore, the prior art apparatus of Linfors et al. would be structurally capable of winding the filter to a predetermined distance.
Regarding claim 11, modified Linfors et al. teaches the bacterial cell counting device according to claim 9. Linfors et al. teaches one used section but fails to teach that the filter tape comprises at least two used region, an earlier used region is recallable for measurement by winding the filter tape to that earlier used region. Nevertheless, the addition of multiple used regions would be a mere duplication of parts, as the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04 VI B). The addition of multiple used regions would create the same windable filter cassette present in the bacterial cell counting device. Therefore, the claim is prima facie obvious and lacks patentable significance.
Regarding claim 14, modified Linfors et al. teaches the bacterial cell counting device according to claim 1. Furthermore, Linfors et al. teaches an optical detector for measuring the colorimetric and/or fluorescence output emitted from the bacterial cells modified by the reagents “The emitted light is observed by means of a detector, for instance a photomultiplier tube 12a. With certain predetermined analysis conditions the emitted Light is a measure of the amount of microorganisms.” (p. 2, lines 27-35). Therefore, the claim is prima facie obvious.
Regarding claim 17, modified Linfors et al. bacterial cell counting system comprising: the cell counting device according to claim 1. Furthermore, the combination of references of claim 1 would encompass a structure of a control system operable to automatically and sequentially flow the reagents and sample to the filter strip via the optofluidic chip. Therefore, the claim is prima facie obvious.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Linfors et al. (already referenced), Holmes (already referenced) as applied to claim 1 above, and further in view of Chen et al. (WO 2018052851 A1) (referenced in IDS).
Regarding claim 7, modified Linfors et al. teaches bacterial cell counting device according to claim 1, but fails that the optofluidic chip is specifically a microfluidic chip. Chen et al. teaches microfluidic filter devices for capturing objects (eg. a red blood cell) (abstract), wherein Chen et al. teaches that a microfluidic chip can exist alone or can be part of a microfluidic system (including pumps, valves, detection equipment) (para. [0037]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Chen et al.’s teaching of a microfluidic chip in Linfors et al. device because the microfluidic chip can be included or integrated into a microfluidic system including pumps, valves, and detection equipment. This method of improving Linfors et al. device was within the ability of one of ordinary skill in the art based on the teachings of Chen et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and Chen et al. to obtain the invention specified in claim 7.
Regarding claim 8, modified Linfors et al. teaches bacterial cell counting device according to claim 1, but fails to teach wherein the optofluidic chip further comprises at least a means for chamber pressurization. Chen et al. teaches microfluidic filter devices for capturing objects (eg. a red blood cell) (abstract), wherein Chen et al. teaches means for chamber pressurization through pumps (invoked via 112(f)), valves for introducing fluids (samples, reagents, buffers, and the like) – wherein the valves and flow in such systems may be pressure driven (para. [0037]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Chen et al.’s teaching of means of chamber pressurization in Linfors et al.’s device because chamber pressurization (through pumps, valves introduce fluids (Samples, reagents, buffers) via pressure. This method of improving Linfors et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Chen et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and Chen et al. to obtain the invention specified in claim 8.
Claims 12, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Linfors et al. (already referenced), Holmes (already referenced) as applied to claim 1 above, and further in view of McDevitt et al. (US 20060257991 A1) (referenced in IDS).
Regarding claim 12, modified Linfors et al. teaches bacterial cell counting device according to claim 1, but fails to teach that the filter strip is a PVDF membrane having a pore size of about 0.22. “Membrane 110 may be about 5-10 microns in thickness. Membrane 110 includes a plurality of pores. Pores may range from about 0.2 μm in diameter up to about 12 μm in diameter to capture potentially dangerous microbes.” It has been established in MPEP 2144.05 that where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. The claimed range of 0.22 μm overlaps with the prior art’s range of 0.2 μm to 12 μm in diameter. Therefore, the claim is prima farcie obvious.
Regarding claim 13, modified Linfors et al. teaches bacterial cell counting device according to claim 1, but fails to teach a waste collection tank for containing the reagents and sample after elution from the optofluidic chip. McDevitt et al. teaches a waste receptacle (See FIG. 3), wherein the fluids may be forced to pass through a membrane-based fluid sensor 100 to allow capture of analytes or the addition of development agents ("flow through" mode), as the waste fluid enters waste receptacle following this operation (para. [0135]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use McDevitt et al.’s teaching of a waste collection tank in Linfors et al.’s device because the waste collection tank allows fluid following a “flow through” operation where analytes are captured to be collected. This method of improving Linfors et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of McDevitt et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and McDevitt et al. to obtain the invention specified in claim 13.
Regarding claim 15, modified Linfors et al. teaches bacterial cell counting device according to claim 1. Modified Linfors et al. fails to teach that the control is a calibration plot. McDevitt et al. teaches a dose response curve – where a standard curve is used (calibration plot) (para. [0166]), wherein the calibration curve was built from the measurement of four different spore solutions accounting for 900, 3000, 9000, and 30000 spores (para. [0166]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use McDevitt et al.’s teaching of a calibration curve in Linfors et al.’s device because the calibration curve enables measurements of different spore solutions. This method of improving Linfors et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of McDevitt et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and McDevitt et al. to obtain the invention specified in claim 15.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Linfors et al. (already referenced), Holmes (already referenced) as applied to claim 1 above, and further in view of Schofield (US 20100285460 A1) (referenced in 892).
Regarding claim 16, modified Linfors et al. teaches bacterial cell counting device according to claim 1. Modified Linfors et al. fails to teach that the bacterial cell counting device is characterized by a limit of detection of about 1000 CFU/ml. Schofield teaches detections of 500-1000 Listeria CFU/mL (bacteria), as Schofield teaches that the ability to detect low concentrations of spores are an important characteristic of a detection methodology (para. [0158]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Schofield’s teaching of a detections of 500-1000 CFU/ml bacteria in Linfors et al.’s device because the detection of low concentrations of spores are important in characteristic of a detection methodology. This method of improving Linfors et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Schofield. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Linfors et al. and Schofield’s to obtain the invention specified in claim 16. Furthermore, it has been established in MPEP 2144.05 that where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Since the 1000 CFU/ml limit of detection lies within the prior art range disclosed by Schofield, a prima facie case of obviousness exists.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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