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 .
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on Page 9 regarding the object being different than a subject and that the biofluid emitted by the skin of the subject is not the same as the fluid emitted by the surface of an object, the Examiner respectfully asserts that inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims, see MPEP 2115. In this case, the “object” and the fluid emitted by the object being examined by the invention is not a positively recited element of the invention, and therefore cannot limit the scope of the invention.
In response to Applicant’s argument that Rogers does not teach the newly amended limitation of the “… microfluidic sensor for the detection of ammonia in fluids emitted by a surface of an object,” the Examiner points out that Applicant's arguments rely on language solely recited in preamble recitations in claim 1. When reading the preamble in the context of the entire claim, the recitation above is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention's limitations. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
However, in light of Applicant’s amendment to clarify the previously claimed “polymer matrix” as an ion gel that is wholly different than the hydrogel taught by Rogers et al., and the Examiner respectfully agrees. In light of this amendment, the rejection of the claim is now unpatentable over Rogers et al. (WO2017218878) in view of Saez et al., “Ionogel-based Nitrate Sensor Device.” Saez et al. teaches a system where ionogels are used to capture a reagent for colorimetric data, as the use of ionogels to capture a reagent for testing provides improvements in robustness of the device, see Introduction.
The use of an ionogel in place of a hydrogel, specifically the hydrogel of Rogers et al., was known and obvious in the art before the effective filing date of the instant invention, as evidenced by Saez et al., see Introduction. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have substituted the hydrogel of Rogers et al. for an ionogel as exemplified by Saez et al. for the benefit of improving hydrogel properties by incorporating ionic liquid to the matrix by increasing robustness of the gel matrix for long-term reagent storage, see Introduction of Saez et al. Further, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, the claim would have been obvious, see MPEP §§ 2143(I)(B).
On Page 10, the Applicant asserts that Rogers does not teach copper chloride being the reactive substance for the analyte of ammonia. In response to this argument, the Examiner respectfully agrees, however, in light of the amendment to independent claim 1 which alters the scope of the claim in light of the dependent claims, the rejection is now made over Rogers et al. in view of Patel (US 2009/0301382).
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 9-10 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 9 refers to the “the polymer matrix,” however, there is insufficient antecedent basis for this limitation in the claim as there is no “polymer matrix” currently being claimed by the invention. Instead, reference is made to an ion gel in claim 1, which is located within the Markush group of claim 9. The Examiner suggests cancelling the claim or amending the claim to align with the scope of claim 1.
Claim 10 is rejected due to its dependence on claim 9.
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, 9-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (WO2017218878) in view of Saez et al., “Ionogel-based Nitrate Sensor Device” and Patel (US 2009/0301382).
Regarding claim 1, Rogers et al. teaches a microfluidic sensor for the detection of ammonia in fluids emitted by a surface of an object (microfluidic device 10 for detecting compounds emitted in sweat, or on the surface of an object, see Fig. 1 and [0046]), characterized in that the microfluidic sensor comprises:
a contact surface configured to be attached using a pressure-sensitive adhesive to a surface of the object (bottom of adhesive layer 140 that directly contacts skin, where the adhesive sticks to the skin in response to pressure, see [0020], [0198] and Fig. 1);
an inlet hole in the contact surface for the entry of fluids emitted by the surface of the object (inlet 130 for accepting fluid, see Fig. 1 and [0198]);
a first reservoir (64) which stores a gel (CoCl2 ion contained within the hydrogel, see [0027]) the gel comprising a reactive substance which is configured to change color when it enters into contact with at least one analyte present in the fluids emitted by the surface of the object (hydrogel 68 within reservoir 64 contains reagent 282 that changes color in response to analyte, see [0198] - [0200], where the reagent is the CoCl--2, see [0027]); and
at least one first microfluidic duct which connects the inlet hole to the first reservoir (microfluidic channel 62 connects inlet 130 to reservoir 64, se Fig. 1 and [0198] – [0200]), but does not teach that the gel is an ion gel.
However, in the analogous art of gelling reagents for microfluidic platforms, Saez et al. teaches a system where ionogels are used to capture a reagent for colorimetric data, as the use of ionogels to capture a reagent for testing provides improvements in robustness of the device, see Introduction.
The use of an ionogel in place of a hydrogel, specifically the hydrogel of Rogers et al., was known and obvious in the art before the effective filing date of the instant invention, as evidenced by Saez et al., see Introduction. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have substituted the hydrogel of Rogers et al. for an ionogel as exemplified by Saez et al. for the benefit of improving hydrogel properties by incorporating ionic liquid to the matrix by increasing robustness of the gel matrix for long-term reagent storage, see Introduction of Saez et al. Further, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, the claim would have been obvious, see MPEP §§ 2143(I)(B).
Further, modified Rogers et al. does not teach that the reactive substance is copper (II) chloride.
However, in the analogous art of adhesive devices for monitoring chemicals, Patel teaches a device for monitoring chemical change wherein the colorimetric indicator, analogous to the CoCl2 of Rogers et al., where the reactive species is copper chloride (CuCl-2), see [0469] – [0470]. The CuCl2 of the applicant and of the prior art are the same structure and are therefore assumed to have the same qualities unless shown by the Applicant to be dissimilar, In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The modification of an indicator device to incorporate a reactive metal salt to such as cupric chloride was known before the effective filing date of the instant invention, as evidenced by Patel, see [0469] – [0470]. It was also known that the invention of Rogers was ready for improvement as any colorimetric reagent was capable of being provided within the microfluidic channel, see [0027]-[0028]. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have substituted the CoCl2 reagent of Rogers et al. for the CuCl-2 reagent of Patel for the benefit of providing a colorimetric reagent that creates a complex with ammonia or another analyte of interest, see [0469] – [0470] in Patel. Further, because CoCl2 and CuCl2 are indicating compounds, they would have exhibited similar behavior in response to their respective target analytes and would have had the reasonable expectation of facilitating colorimetric detection of a target analyte in a liquid sample.
Regarding claim 2, modified Rogers et al. teaches the microfluidic sensor according to claim 1, wherein the reactive substance is configured to change color by reaction with the at least one analyte at an intensity proportional to the concentration of the analyte (the reagents 282 are color responsive to relative concentrations of an analyte, see [0200]).
Regarding claim 3, modified Rogers et al. teaches the microfluidic sensor according to claim 1, comprising:
a second reservoir configured to store moisture coming from the first reservoir (second sensor 280/282/284 for detection of pH, see Fig. 1 and [0199]);
and at least one second microfluidic duct which connects the first reservoir to the second reservoir (channel portion 60 leading to chamber 280/282/284, see Fig. 1 and [0198] – [0200]).
Regarding claim 9, modified Rogers et al. teaches the microfluidic sensor according to claim 1, wherein the polymer matrix is an ion gel (see Introduction of Saez et al.)
Regarding claim 10, modified Rogers et al. teaches the microfluidic sensor according to claim 9, wherein the ion gel is formed by ions selected from a group consisting of: imidazole (ion gel of Saez et al. is constructed of 1-ethyl-3-methylimidazolium ethyl sulfate).
Regarding claim 11, modified Rogers et al. teaches the microfluidic sensor according to anyone of the preceding claims1, wherein the microfluidic sensor is transparent (the substrates and microfluidic system are transparent, see [0019], [0026], and [0116]).
Regarding claim 12, modified Rogers et al. teaches the microfluidic sensor according to claim 1, wherein the object is a work of art (the device is attached to a person, or an object, see Abstract).
A claim is only limited by positively recited elements. Therefore, inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 13, modified Rogers et al. teaches the system for the detection of analytes in an object (microfluidic device and communication system, see [0005]), the system comprising:
a microfluidic sensor according to claim 1 (see Fig. 1 and [0198] – [0200])
a detection unit configured to detect the change in color of the reactive substance in the first reservoir of the microfluidic sensor (UV- vis spectrometer that detects change in color in each reservoir, see [0046])
Regarding claim 14, modified Rogers et al. teaches the system for the detection of analytes according to claim 13, wherein the detection unit comprises a camera for monitoring the microfluidic sensor and a digital image processing module to detect the change in color of the reactive substance in the first reservoir of the microfluidic sensor (optical imager and UV-Vis spectrometer used to detect and monitor color changes in the detection reservoir over time, see [0046]).
Regarding claim 20, modified Rogers et al. teaches the microfluidic sensor according to claim 1, wherein the object is selected from the group consisting of a work of art, paintings, murals, sculptures, photographs, buildings, and construction materials (the device is attached to a person, or an object, see Abstract). The Examiner notes that inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims, see MPEP 2115.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable Rogers et al. (WO2017218878) in view of Saez et al., “Ionogel-based Nitrate Sensor Device” and Patel (US 2009/0301382) as applied above, and further in view of DeRosa et al. (US 2012/0052250).
Regarding claim 4, modified Rogers et al. teaches the microfluidic sensor according to claim 1, comprising:
a first pressure-sensitive adhesive sheet having a first hole in correspondence with the inlet hole of the microfluidic sensor (adhesive layer 140 with openings 145, see Fig. 1);
a sheet of poly(methyl methacrylate) comprising the inlet hole, the first reservoir and the at least one first microfluidic duct (functional substrate 30 comprising inlet 130 and channel 60 is made of PMMA, see [0026] and [0136]);
wherein the first pressure-sensitive adhesive sheet is adhered to the object and to the sheet of poly(methyl methacrylate) (the adhesive layer 140 is stuck to the subject and the PMMA layer 130, see Fig. 1 and [0198]),
However, while the prior art of Rogers et al. teaches that the top capping layer comprises a clear polymer such as PDMS, the reference does not teach that the device comprises cyclic olefin polymer or a second pressure-sensitive adhesive sheet having a second hole in correspondence with the first reservoir; and
and wherein the second pressure-sensitive adhesive sheet is adhered to the sheet of poly(methyl methacrylate) and to the sheet of cyclic olefin polymer.
However, in the analogous art of flexible microfluidic systems, DeRosa et al. teaches a microfluidic system consisting of multiple stacked layers with a microporous network 110, see Fig. 18 (analogous to the functional substrate of Rogers et al.) including a sheet of cyclic olefin polymer (the top layer 400 of cyclic olefin copolymer, see [0092]) with a second pressure-sensitive adhesive sheet having a second hole in correspondence with the first reservoir (intermediate layer 300 constructed of pressure-sensitive adhesive, see Fig. 18 and [0089]); and
and wherein the second pressure-sensitive adhesive sheet is adhered to the sheet of poly(methyl methacrylate) and to the sheet of cyclic olefin polymer (the intermediate layer 300 is stuck to the top layer 400 of cyclic olefin copolymer and the flexible polymer 140, see Fig. 18 and [0092] – [0094]). Implementation of the intermediate adhesive layer between the functional layers, and including a layer of cyclic olefin polymer was known before the effective filing date of the instant invention as evidenced by DeRosa et al. for the benefit of the rapid and simple assembly of a modular microfluidic device with a transparent protective film, see [0089] and [0092].
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Rogers et al. to include the pressure-sensitive adhesive and cyclic polyolefin top layer of DeRosa et al. for the benefit of preventing leakage between the more rigid polymer layers of the invention, see [0089] in DeRosa et al. Additionally, the modification of the microfluidic device of Rogers et al. to include the pressure-sensitive adhesive and olefin of DeRosa et al. would have resulted in the predictable result of facilitating fluid transport across the microfluidic channels using a self-assembled device.
Regarding modified claim 5, Rogers et al. teaches the microfluidic sensor according to claim 4, wherein the sheet of poly(methyl methacrylate) comprises the second reservoir and the at least one second microfluidic duct (the functional substrate 30 contains the channel 60 and second reagent chamber, see Fig. 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
Prosecution Insights