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 IV, Claim 8 in the reply filed on May 29th, 2026 is acknowledged.
Claims 21-32 are newly added and dependent form claim 8 and are under examination therewith.
Claims 1-7 and 9-20 are canceled.
Claim Objections
Claim 8 is objected to because of the following informalities: The term “complimentary” appears to be in error in which Applicant instead intends to utilize “complementary.” Appropriate correction is required.
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.
Claim 22 and 23 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.
The metes and bounds of the claim are indefinitely defined as claim 8 sets forth open-ended language of “…comprising a polymer…” and wherein claim 22 both does not correlate the polymer recited in claim 8 to that of the PVA film in claim 22 and in which presents an additional element to the sensing film that is contrary to the “only contains…” language therein.
Does Applicant intend to recite in claim 22 something on the order of “…wherein the top layer consists of the polymer, and wherein the polymer is polyvinyl acetate?” Something else?
Lastly, the designation of “film” is not particularly understood herein. Claim 8 already establishes the form of a layer. Does Applicant intend to recite initially in claim 8 “…comprising a polymer film,” however, this recitation appears redundant to the recitation of a top layer.
This is similarly seen in claim 23. It is also noted that the overall device is couched as a sensing film, wherein such film is made up of layers, which further calls into question the layer/film recitations to the individual elements herein.
Further, as in claim 23, the recitation to the first layer comprises a polymer film is indefinitely understood. Claim 8 already provides a hydrogel layer, wherein hydrogels are polymers, and thus the claims provides a presentation of a species followed by a genus. Is this “polymer film” a further/additional element to that of the first layer? Clarification is required.
Claims 24 and 32 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.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the particular wire material and, accordingly, the identification/description is indefinite.
Dowsil 3140 is a trademark of the Dow Chemical Company.
Claim 31 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.
The metes and bounds of the constitution of the sensing layer are indefinitely defined herein.
Independent claim 8 already provides that the sensing layer comprises an ionophore, such that the recitation to “ionophore” herein claim 31 is not definitely understood if this is an additional, different ionophore from that established in claim 8 or if it is a redundant recitation. Does Applicant intend that the sensing layer further comprises a polymer, lipophilic salt, and a plasticizer?
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.
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) 8, 23, 25-30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramamurthy et al. (US 2008/0152864), hereafter Ramamurthy, in view of Javey et al. (US 2018/0263539), hereafter Javey.
With regard to claim 8, Ramamurthy discloses an ion sensitive hydration sensing film (and which may be drop cast in as much as claimed and required herein, see also par.[0018], in which no such process of manufacturing is necessitated by the claim and such recitation is drawn to prospective intended usage not afforded patentable weight) comprising a first layer comprising a hydrogel layer (layer 400, par.[0028], fig. 1, and wherein a hydrogel is a polymer so as to constitute the first layer comprises a polymer film as in cl. 23) which aids in adhering the sensing film to the carbon pads (wherein Examiner notes that the carbon pads are drawn to prospective workpieces and are not positively claimed elements of the sensing film).
Ramamurthy further discloses a sensing layer (layer 500; par.[0027], fig. 1) comprising an ionophore and complementary salt for an ion of interest, which helps generates a membrane potential as claimed (and noting that steps of analysis are not necessitated by the device claim), and the recitation to “wherein the sensing layer is applied to the first layer” is drawn to a process recitation not afforded patentable weight; if Applicant desires a particular arranged, multi-layer stack, Applicant should amend the claims to present a multi-layered arrangement with respect to structural confines of apparatus/individual layers.
Ramamurthy further discloses a top layer comprising a polymer (layer 300; par.[0029], fig. 1; wherein “top” is a designation in accordance with the structural constitution that it is applied to the sensing layer, which structural constitution is provided in Ramamurthy; this is further seen as “top” is a matter of perspective viewpoint; and as above “applied to…” is drawn to a process recitation not afforded patentable weight), which protects the sensing layer from outside interference and damage and adds to overall stability while allowing diffusion of ions from solution into the sensing layer as claimed.
With regard to claims 25-30, the recitations are drawn to a process recitations not afforded patentable weight within the device claim.
With regard to claim 32, the recitation is drawn to process recitations not afforded patentable weight within the device claim.
Further, such recitation is drawn to a product-by-process recitation, wherein scope of the product is defined at least in part in terms of the method or process by which it is made. In this case, the end product of the sensing film is defined by “manufactured in the following manner…” Applicant is reminded that the product-by-process claim is always to a product. The reference need only to substantially meet the structure of the end product, and which is provided by Ramamurthy as discussed above in claim 8.
With regard to claim 8, Ramamurthy does not specifically disclose the sensing layer comprises the complementary salt for an ion of interest.
Javey discloses wearable sensor arrays for in-situ body fluid analysis (abstract). Javey discloses a wearable sweat biosensor may have its sensing recognition element comprised of the combination of an ionophore and complementary salt for an ion of interest by utilizing valinomycin (a polyether ionophore that selectively transports potassium ions and is provided with complementary potassium salts for transport across the lipid membranes) (par.[0079], “Supplementary Table 1”, page 10, for example).
It would have been obvious to one of ordinary skill in the art to modify Ramamurthy to include in the sensing layer an ionophore and complementary salt for an ion of interest such as taught by the analogous art of Javey to wearable biosensors, in which utilizing valinomycin is an obvious alternative form to the sensing layer to the similarly provided ionophore/fluorescence sensing molecules of Ramamurthy in which valinomycin provides a combined ionophore with complementary salt for a fully integrated sensing layer for biosensing applications (as likewise desired in Ramamurthy; pars.[0003,0004]).
Claim(s) 21 and 24, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramamurthy in view of Javey, as applied above to claims 8, 23, 25-30, and 32, and in further view of Zhou et al. (US 2007/0099311), hereafter Zhou.
Ramamurthy/Javey does not specifically disclose that the top layer comprises PDMS, and likewise, as best understood, with respect to the PDMS as in cl. 24.
Zhou discloses wicking devices (abstract). Zhou discloses covering the nanowick with a PDMS layer in contact with the nanowick in order to control the humidity such that a desired evaporation rate is obtained (par.[0067]).
It would have been obvious to one of ordinary skill in the art to modify the sensing film of Ramamurthy to provide the top layer comprising PDMS (and PDMS as best understood as in cl. 24) such as taught by the analogous art of Zhou in a fluid transport device wherein utilizing PDMS/form thereof as the top layer provides a suitable material to the top layer for desirably achieving humidity control as likewise contemplated in Ramamurthy (par.[0029] with top layer 300).
Claim(s) 31, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramamurthy in view of Javey, as applied above to claims 8, 23, 25-30, and 32, and in further view of Shin et al. (US 2004/0256227), hereafter Shin.
Ramamurthy/Javey does not specifically disclose that the sensing layer comprises a polymer, ionophore, lipophilic salt, and a plasticizer.
Shin discloses an electrochemical urea sensor (abstract). Shin discloses an ammonium ion-selective polymeric layer 175 that includes an ammonium-selective ionophore, plasticizers, and lipophilic salts to particularly regulate the sensitivity of the polymeric membrane of the ISE to the analyte of interest (par.[0049,0050], fig. 3, for example).
It would have been obvious to one of ordinary skill in the art to modify Ramamurthy/Javey to provide a sensing layer comprises a polymer, ionophore, lipophilic salt, and a plasticizer such as taught by the analogous art of Shin to polymeric membrane sensors in which such a sensing layer provides to particularly regulate the membrane to the analyte of interest and provide for particular capture of the analyte of interest.
Allowable Subject Matter
Claim 22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, does not teach or fairly suggest, as best understood herein, a sensing film as recited in claim 22, wherein the top layer only contains a polyvinyl alcohol film. Examiner notes that the present recitation is indefinitely defined and provided for herein in terms of the sought limited, “consisting of” (“only” herein) type language sought in reference to the independent claim 8 so as to particularly surmise the sought structural constitution of the sensing film of claim 22.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798