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 § 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 1-18 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 recited “if filled” is ambiguous as to the metes and bounds as the phrase “when the measuring chamber” is not a typical conditional “if, then” statement, but appears to be a declarative phrase. For prosecution, the phase will be interpreted as “is filled”. Claims 2-18 are rejected because of their dependency and failure to remove the ambiguity of the parent claim.
Claim Objections
Claims 1, 3, 8, 9, and 11 are objected to because of the following informalities:
Claims 1, 8, 9, and 11 recite the limitation "the fluid pump" in line 13 (claim 8: line 2; claim 9: line 2; claim 11: line 3. The limitation is properly recited as “passive fluid pump” as there is antecedent support in line 11 of claim 1. Appropriate correction is required.
Claim 3, recite the limitation "the stop valve” in line 1. The limitation is properly recited as “stop passive valve” as there is antecedent support in line 4 of claim 2. Appropriate correction is required.
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.
Claim(s) 1, 8-15 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Heinkenfeld (US 20200138347).
Regarding claim 1, Heikenfeld teach a microfluidic system (Para. 0073: microfluidic) for continuous monitoring of metabolites and/or properties of biofluids, the system comprising (Abstract: biofluid sample):
one measuring chamber (Fig. 11A: 1132, Para. 0086 ),
at least one inlet for the input of a biofluid (Fig. 11A: inlet leading to 1101) ,
a microfluidic intake channel fluidly communicating the inlet with the measuring chamber (Fig. 11A: 1101)
at least one sensor suitable for measuring a parameter of an analyte of a biofluid, and arranged to measure the parameter of a biofluid contained in the measuring chamber (Para. 0086; Fig. 11A: analyte specific sensor 1120),
a passive fluid pump fluidly communicated with the measuring chamber (Para. 0086; Fig. 11A: 1197: concentrator pump), and adapted to generate a capillary pressure greater than the biofluid generation pressure (Para. 0080: wicking force reads on "capillary pressure"; Para. 0086: draw rate of concentrator pump reduces the path 1103 to zero when valve 1155 is open),
a retention valve interposed between the measuring chamber and the fluid pump (Fig. 11A: valve 1155), wherein the retention passive valve is configured to stop flow of biofluid for a certain period of time, when the measuring chamber if filled with biofluid (Para. 0086: valve closed controls fluid flow so that sensor 1126 is wetted).
Regarding claim 8, Heikenfeld teach the fluid pump is a micro- machined capillary pump capable of forcing fluid circulation by capillary action (Para. 0053: wicking collector can be a microfluidic component)
Regarding claim 9, Heikenfeld teach the fluid pump is a porous material pump. (para. 0053: wicking collector can be a textile)
Regarding claim 10, Heikenfeld teach comprising a cycle detector adapted to detect when the measuring chamber is filled with biofluid, and to monitor changes on cycle frequency. 1126/1128 sensors and para. 0061: two or more electrical electrodes
Regarding claim 11, Heikenfeld teach the cycle detector comprises two electrodes arranged to measure an electric parameter at the microfluidic circuit between the inlet and the fluid pump inlet, so as to detect whether there is a biofluid or air in the microfluidic circuit. 1126/1128 sensors and para. 0061: two or more electrical electrodes
Regarding claim 12, Heikenfeld teach the inlet is adapted to collect sweat from the skin of a subject. (Para. 0068: sweat conductivity)
Regarding claim 13, Heikenfeld teach adapted to monitor sweat metabolites and/or properties, and wherein the sweat properties include conductivity and/or sweat rate and/or sweat pH, and/or ions. (Para. 0068: sweat conductivity)
Regarding claim 14, Heikenfeld teach further comprising an electronic device electrically communicated with the sensor, and adapted for processing data generated by the sensor. (Para. 0064: reader device 150 such as a smart phone)
Regarding claim 15, Heikenfeld teach wearable device for sweat monitoring incorporating the system of claim 1, and wherein the system is configured as a disposable cartridge detachably coupled with the wearable device. (Para. 0061-0063: wearable device; device can be secured against the skin by other mechanisms that are wearable near the skin such as straps or helmets).
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.
Claim(s) 2-4, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld in view of Rogers et al (US 20200155047).
Regarding claim 2, Heikenfeld is silent to a secondary microfluidic channel connected to the microfluidic intake channel and connected to the atmosphere, and a stop passive valve interposed at the secondary microfluidic channel, and adapted to impede fluid flow out of the secondary microfluidic channel towards the atmosphere.
Rogers teach a secondary microfluidic channel connected to the microfluidic intake channel and connected to the atmosphere (Fig. 31: dual expunge ports connected to the microfluidic sweat inlet and the atmosphere at 322 and 324), and a stop passive valve interposed at the secondary microfluidic channel (Fig. 31: capillary burst valve 70), and adapted to impede fluid flow out of the secondary microfluidic channel towards the atmosphere. It is advantageous to provide a secondary channel and stop passive valve to allow for expunging the sample to allow for further sample analysis.
Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the secondary channel and stop passive valve of Rogers to the device of Heikenfeld to provide the above advantage of allowing for expunging the sample to allow for further sample analysis.
Regarding claim 3,Heikenfeld/Rogers teach the stop valve is configured such that its bursting pressure is greater than the maximum biofluid generation pressure. (Rogers: Fig. 31: valve 70 bursting pressure is greater than the maximum biofluid generation pressure, so the fluid flows into the reservoir and not the expunge ports 320; Para. 0331: reduce the accidental sweat discharge)
Regarding claim 4,Heikenfeld/Rogers teach the bursting pressure of the valve (Rogers: Para. 0026: 0kPa to 10kPA bursting pressures). The bursting pressures can be selected to control the fluids throughout the device (Rogers: Para. 0006). It is advantageous to provide the bursting pressure of the retaining valve is lower than the bursting pressure of the stop passive valve to ensure the sweat does not go into the dual expunge ports, but gets directed to the retention valve. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine bursting pressure of the retaining valve is lower than the bursting pressure of the stop passive valve to provide the above advantage of ensuring the sweat does not go into the dual expunge ports, but gets directed to the retention valve.
Regarding claims 16, Heikenfeld/Rogers teach the bursting pressure of the valve (Rogers: Para. 0026: 0kPa to 10kPA bursting pressures). The bursting pressures can be selected to control the fluids throughout the device (Rogers: Para. 0006). 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 bursting pressure of the retention valve is a result effective variable that gives the well known and expected results of providing controls of the fluids throughout the device. In the absence of a showing of unexpected results, the Office maintains the bursting pressure of the retention valve is within the range 2.4 - 6 kPa would have been within the skill of the art as optimization of a results effective variable.
Claim(s) 5, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld.
Regarding claims 5 and 17, Heikenfeld teach the retention valve is configured to feature a bursting pressure that retain the measuring chamber filled with biofluid and stop biofluid flow for a period. (Para. 0086: device repeatedly concentrates the fluid sample, sense the analyte, then eliminates the fluid sample in preparation for another sensing event). Heikenfeld is silent to the period within the range 1 minute to 5 hours; period within the range the range 1 to 5 minutes. 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 the period to stop the biofluid flow is a result effective variable that gives the well known and expected results of providing sufficient time to perform the sensing the analyte. In the absence of a showing of unexpected results, the Office maintains the period within the range 1 minute to 5 hours; period within the range the range 1 to 5 minutes would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 18, Heikenfeld teach wicking force of the concentrator pump 1197 should be greater to reduce fluid flow through path 1103 to zero if valve 1155 were open (Para. 0086) Heikenfeld is silent the passive fluid pump is adapted to generate a capillary pressure higher than 6 kPa. 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 the passive fluid pump is adapted to generate a capillary pressure higher than 6 kPa is a result effective variable that gives the well known and expected results of providing pressure to reduce the fluid flow to path 1103 to zero. In the absence of a showing of unexpected results, the Office maintains the passive fluid pump is adapted to generate a capillary pressure higher than 6 kPa would have been within the skill of the art as optimization of a results effective variable.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld in view of Begtrup et al (US 20190008448).
Regarding claims 6-7, Heikenfeld teach the retention passive valve, but is silent to the retention passive valve is configured as a sudden enlargement of the cross-section area of the microfluidic intake channel; the retention passive valve is configured as a chemical modification of the surface of the microfluidic intake channel. Begtrup et al teach sweat sensing devices that varying channel cross section and inner surface treatments for to facilitate individual applications to deal with variations in sweat volume rates. (Para. 0068). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the retention passive valve of Heikenfeld with the Begtrup varying channel cross section and inner surface treatments to provide the above advantage of facilitating individual applications to deal with variations in sweat volume rates.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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