DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/2025 has been entered.
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 6-10, 21-25 are pending.
This action is Non-Final.
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.
Claims 1-4, 6-10, 21-25 are 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.
Claim 1 has been amended to recite the limitation of “a hydrogel layer comprising a plurality of thermo-responsive hydrogel valves corresponding to the plurality of compartments, wherein the thermo-responsive hydrogel valves have a transition temperature above 35°C” which is rejected for being new matter/lack of adequate written description. The amendments and remarks do not identify where support for this limitation is found in the disclosure as filed. After review, it appears such scope is actually directly counter to what is stated in the disclosure as filed. The most relevant passages in the specification as filed are paragraphs [0020], [0043]-[0044] and Figure 12. However, nowhere is there present that the valves function with a transition temperature above 35 degrees C as set forth. The closest feature to the claims is in paragraph 43 which states the transition temperature is sufficiently above 35 degrees C, not 35 degrees itself. However, “sufficiently” is in itself a relative/subjective term that does not connotate any particular meaning and thus cannot support the scope being claimed. The disclosure uses above 44, or above or equal to 45 degrees C as the transition temperatures. As such, one of ordinary skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed. The dependent claims are rejected for depending on a rejected claim.
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, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610).
Regarding claim 1, Bartetzko teaches a device comprising:
a microfluidic layer having a plurality of compartments (see at least Figure 5, col. 3 line 63- col. 4 line 5, col. 6 line 57- col. 7 line 9 interpreted to read on sample capture structure; the inclusion of plurality of compartments is suggested: see col. 4 lines 43-48 “It may be noted that, as used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a material" may include mixtures of materials, reference to "a chamber" may include multiple chambers, and the like.”);
a hydrogel layer (see at least Figure 5, col. 3 line 63- col. 4 line 5, col. 6 line 57- col. 7 line 9 interpreted to read on hydrogel); and
an electrode layer comprising a plurality of sensors respectively corresponding to the plurality of compartments (see at least Figure 5, col. 3 line 63- col. 4 line 5, col. 6 line 57- col. 7 line 9 interpreted as electrodes; the inclusion of plurality of electrodes is suggested: see col. 4 lines 43-48 “It may be noted that, as used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a material" may include mixtures of materials, reference to "a chamber" may include multiple chambers, and the like.”).
However, the limitation of the hydrogel layer comprising a plurality of thermo-responsive hydrogel valves corresponding to the plurality of compartments, wherein the thermo-responsive hydrogel valves have a transition temperature above 35°C, and a plurality of pressure release mechanisms respectively configured to regulate hydraulic pressure in the plurality of thermos-responsive hydrogel valves and corresponding plurality of compartments are not directly taught.
Chen teaches a related system for analyzing biological samples (see title and abstract), and teaches the usage of valves to control flow to chambers, and teaches valves can be temperature actuated hydrogel valves which reasonably teaches the limitations that the hydrogel layer comprising a plurality of thermo-responsive hydrogel valves corresponding to the plurality of compartments (see at least [0072]-[0075], [0094]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using a hydrogel as a valve in order to control sample fluid movements as desired.
Chen does not teach wherein the thermo-responsive hydrogel valves have a transition temperature above 35°C, but does teach the thermo-responsive hydrogel comprises poly(N- isopropylacrylamide) (PNIPAM) (see at least [0073]).
Stayton teaches a related system included temperature responsive polymers, and teaches that PNIPAM is a known polymer, and which can be turned as desired by cross-linking, which could include temperatures above 35C (see at least [0003]-[0004], Fig. 4). McKnight teaches that in a biological application it would be desirable for a thermally responsive polymer to be above physiological temperature above 39C. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of tuning hydrogel transition temperature to be a desired temperature above physiological temperatures. The combined teachings would lead one of ordinary skill to modify Bartetzko, which is for applications of biofluids, to include a thermal responsive hydrogel valve, as taught by Chen, to be tuned by crosslinking, as taught by Stayton, to be a temperature above physiological basal values, as taught by McKnight, in order to control when valves should be properly opened and closed in a microfluidic system.
Petavi teaches a related system for microfluidic systems (see title and abstract), and teaches that various channels may include a ambient air vents to ambient environment (see [0103]),which can be used as is known to modulate backpressure that opposes fluid movements (see [0128]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including air vents to the microfluidic system in order to reduce backpressure caused by fluid movements in the system.
Regarding claim 23, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi, where Chen teaches wherein the thermo-responsive hydrogel comprises poly(N- isopropylacrylamide) (PNIPAM) (see entire document, especially [0073]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610) as applied to claim 1 above, and further in view of Ponjee et al. (Ponjee, US 2010/0156444).
Regarding claim 2, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi, where Chen teaches a heater layer (see entire document, especially [0065], [0075], [0094]), and while it is suggested that such heater is controlled by “logic” the limitations of wherein the heater layer is patterned to comprise a plurality of microheaters, each of which is configured to selectively apply heat to a respective one of the plurality of thermo-responsive hydrogel valves is not directly taught.
Ponjee teaches a related system (see title and abstract), and teaches including a heater layer (see entire document, especially [0006], [0042]-[0043]), wherein the heater layer is patterned to comprise a plurality of microheaters, each of which is configured to selectively apply heat to a respective one of the plurality of thermo-responsive hydrogel valves (see entire document, especially [0117]-[0129]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claim invention to combine prior art elements according to known methods to yield predictable results of using logic to selectively activate individual heating elements in a heating layer to control temperature of a sampling element to help regulate flow as desired (see [0008]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610) and Ponjee et al. (Ponjee, US 2010/0156444) as applied to claim 2 above, and further in view of Hussain et al. (Hussain, US 2020/0000403).
Regarding claim 3, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi and Ponjee, except the limitation of wherein the heater layer further comprises a tape-based layer is not directly taught.
Hussain teaches a related system for microfluidics (see [0065]), and teaches using tape for attaching components including heating electrodes (see entire document, especially [0065]). It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including tape in order to aid in attaching different elements of a stacked sensing system.
Claims 4, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610) as applied to claim 1 above, and further in view of Peyser et al. (Peyser, US 2006/0004271).
Regarding claim 4, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight, and Peytavi, except the limitation of further comprising a skin adhesion layer is not directly taught.
Peyser teaches a related system for monitoring analytes (see tittle and abstract), and teaches a microfluidic system (see [0051], [0079]-[0081]) and teaches using skin adhesive (see entire document, especially [0014]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an adhesive layer in order to make a sensing system wearable for a period of time to complete measurements.
Regarding claim 21, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi, where Bartetzko teaches wherein one of the plurality of sensors is configured to sense glucose in biofluid (see entire document, especially col. 5 lines 57-col. 6 line 21), but the limitations and wherein another of the plurality of sensors is configured to sense lactate in biofluid is not directly taught.
Peyser teaches a related system for monitoring analytes (see tittle and abstract), and teaches a microfluidic system (see [0051], [0079]-[0081]) and teaches wherein another of the plurality of sensors is configured to sense lactate in biofluid (see entire document, especially [0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including lactate sensing in order to be used to normalize glucose level as taught by Peyser (see [0076]).
Regarding claim 22, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi and Peyser, where Peyser teaches wherein the biofluid comprises sweat (see entire document, especially [0076]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610) as applied to claim 1 above, and further in view of Hussain et al. (Hussain, US 2020/0000403).
Regarding claim 6, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi, except the limitation of wherein the microfluidic layer further comprises at least one of a PET-based layer and a tape-based layer is not directly taught.
Hussain teaches a related system for microfluidics (see [0065]), and teaches using tape for attaching components (see entire document, especially [0055]). It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including tape in order to aid in attaching different elements of a stacked sensing system.
Regarding claim 7, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi, except the limitation of wherein the hydrogel layer further comprises at least one of a polyethylene terephthalate (PET) based layer and a tape-based layer is not directly taught.
Hussain teaches a related system for microfluidics (see [0065]), and teaches using tape for attaching components (see entire document, especially [0055]). It would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including tape in order to aid in attaching different elements of a stacked sensing system.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610) as applied to claim 1 above, and further in view of Ghaffari, et al. (Ghaffari, US 2017/0296114) and Xiao et al. (Xiao, US 2007/0092407).
Regarding claims 8-10, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi as modified above, except the limitations of wherein the microfluidic layer defines channels between the plurality of compartments having: a serial architecture, having a parallel architecture; having a tree architecture are not directly taught.
Ghaffari teaches a related system for measuring analytes (see entire document, especially [0022]), and teaches that channels for passing testing biofluids can be any desired shape (see entire document, especially [0027]). Xiao teaches a related system with channel delivery arrangement between compartments, where such compartment connections can include serial, parallel, and tree architectures (see entire document, especially Figures 1-3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an obvious design choice to choose fluid channels to be any desired shape as such shape does not have an effect of the principle operation of passing fluid along a path of a microfluidic system. 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.).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bartetzko et al. (Bartetzko, US 8,828,203) in view of Chen et al. (Chen, US 2008/0280285) and Stayton et al. (Stayton, US 2007/0224241) and McKnight et al. (McKnight, US 2010/0241241) and Peytavi (US 2009/0023610) as applied to claim 1 above, and further in view of Rich et al. (Rich, US 2005/0090016).
Regarding claim 24-25, the limitations are met by Bartetzko in view of Chen and Stayton and McKnight and Peytavi, except the limitations of wherein the thermo-responsive hydrogel comprises an ionizable monomer; wherein the ionizable monomer comprises 3- (methacryloylamino)propyl]trimethylammonium chloride (MAPTAC) are not directly taught.
Rich teaches a related device of hydrogel and teaches that various compounds can be used in forming hydrogels binding properties, including ammonia groups such as 3- (methacryloylamino)propyl]trimethylammonium chloride (MAPTAC) (see entire document, especially [0032], [0136]). It would have been obvious to one of ordinary kill in the art before the effective filing date of the claimed invention to include an ionizing monomer compound as desired in a hydrogel as the selection of known materials is prima facie obviousness. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 8/25/2025.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are moot in view of the new grounds of rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791