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 Amendment
Applicant’s amendment filed on 06/29/26 has been entered. Claims 15 is cancelled. Claim(s) 16-20 is/are added. Claim 1-14 and 16-20 are pending and examined herein. Applicant’s remark and amendment have overcome each and every objection and rejection under 112(b) set forth in Office Action mailed on 04/01/26.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: target sample handling system and interferometric system in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Applicant discloses the target sample handling system includes a flow injection system comprising:
at least one pump (para. [0059]; and
at least one in-line mixer (para. [0060]).
Applicant discloses the interferometric system is an optical interferometric system that includes a sensing layer composition (para.[0006]) adhered on at least one side of one or more wave guide channels in/on a waveguide chip (para.[0006])
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (EP 0916946 A2) as cited in previous Office Action
Regarding Claim 1, Wu discloses a sensing layer composition (A composition, method, and test device for quantitatively determining the oxidant concentration of a test sample are disclosed. The test device includes a test pad having a suitable carrier matrix incorporating an indicator reagent composition...An indicator reagent composition is incorporated into a carrier matrix, Abstract; A carrier matrix of the test pad comprises a bibulous material, such as filter paper; a nonbibulous material, such as a strip, layer, Para. [0021]) comprising:
a charge transfer complex comprising an electron acceptor (reagent composition including: (a) an iodide salt, Para. [0022]) and at least one aromatic hydrocarbon (ethoxylated phenol; the indicator reagent composition also can contain ... a nonionic surfactant. Para. [0053]; Useful nonionic surfactants include ... an ethoxylated phenol; Para. [0055]; Also See claims 1, 21 & 22,),
wherein the sensing layer composition is adapted to bind or otherwise be selectively disturbed by one or more analytes (…the present invention is directed to a new and improved composition, test device, and method of determining the peroxide or chlorine concentration of a test sample. Para. [0021]; See Claims 1, 2, 5 & 6; the peroxide comprises peracetic acid; Para. [0077]).
Regarding Claim 2, Wu discloses the claimed sensing layer composition of claim 1, wherein the electron acceptor comprises iodine (…reagent composition including: (a) an iodide salt…Para. [0022]) and the at least one aromatic hydrocarbon comprises an aromatic polymer (Useful nonionic surfactants include, but are not limited to, an ethoxylated polysorbate, e.g. an ethoxylated alcohol, e.g., a C10 to C22 alcohol ethoxylated with about 10 to about 25 moles of ethylene oxide, an ethoxylated phenol, i.e., an ethoxylated octylphenol, nonylphenol, or dodecylphenol with ... a polyethylene glycol, Para. [0055]).
Regarding Claim 3, Wu discloses the claimed sensing layer composition of claim 2, wherein the aromatic polymer comprises phenol, styrene, or a combination thereof (Useful nonionic surfactants include, but are not limited to, an ethoxylated polysorbate, e.g. an ethoxylated alcohol, e.g., a C10 to C22 alcohol ethoxylated with about 10 to about 25 moles of ethylene oxide, an ethoxylated phenol, i.e., an ethoxylated octylphenol, nonylphenol, or dodecylphenol with ... a polyethylene glycol, Para. [0055]).
Regarding Claim 4, Wu discloses the claimed sensing layer composition of claim 1. Wu inherently teaches wherein the sensing layer composition is configured to sense one or more analytes in a liquid that contains acetic acid or hydrogen peroxide without interference from the acetic acid or the hydrogen peroxide (…the present invention is directed to a new and improved composition, test device, and method of determining the peroxide or chlorine concentration of a test sample. Para. [0021]; See Claims 1, 2, 5 & 6; ...the peroxide comprises peracetic acid. Para. [0077]).
Regarding Claim 5, Wu discloses the claimed sensing layer composition of claim 1. In regards to wherein the sensing layer composition is adapted to be adhered to at least one side of one or more waveguide channels in/on a waveguide chip of an interferometric system, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, it meets the claim. In this case, Wu inherently teaches wherein the sensing layer composition is adapted to be adhered to at least one side of one or more waveguide channels in/on a waveguide chip of an interferometric system (…the present invention is directed to a new and improved composition, test device, and method of determining the peroxide or chlorine concentration of a test sample. Para. [0021]).
Regarding Claim 6, Wu discloses the claimed sensing layer composition of claim 5. In regards to wherein the interferometric system is an optical interferometric system, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, it meets the claim. In this case, Wu inherently teaches wherein the interferometric system is an optical interferometric system (…the present invention is directed to a new and improved composition, test device, and method of determining the peroxide or chlorine concentration of a test sample. Para. [0021]).
Regarding Claim 7, Wu discloses the claimed sensing layer composition of claim 1, wherein the sensing layer composition is formulated as a film (A carrier matrix of the test pad comprises a bibulous material, such as filter paper; a nonbibulous material, such as a strip, layer, Para. [0021]; Nonbibulous matrices include glass fiber, polymeric films, Para. [0068]).
Regarding Claim 8, Wu discloses the claimed sensing layer composition of claim 1, wherein the one or more analytes includes peracetic acid (…the present invention is directed to a new and improved composition, test device, and method of determining the peroxide or chlorine concentration of a test sample. Para. [0021]; See Claims 1, 2, 5 & 6; the peroxide comprises peracetic acid; Para. [0077]).
Claim(s) 9, 11, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levin (US 20220091115 A1).
Regarding claim 9 and 11, Levin discloses an analyte sensor system (portable interferometric system 100, Fig. 1) comprising:
a target sample handling system including a flow injection system (According to one embodiment, target sample is introduced by an injection device. Para. [0175]) comprising:
at least one pump (micropump 898, Fig. 8F and para. [0150]; also para. [0175]); and
at least one in-line mixer (mixing bladder 880, Fig. 8F and para. [0150]; also see para. [0176]);
an optical interferometric system (interferometric chip, Fig. 3A) that includes a sensing layer composition (The interferometric chip includes one or more waveguide channels having a sensing layer thereon; para. [0003]) adhered on at least one side of one or more wave guide channels in/on a waveguide chip (para. [0003]), wherein the sensing layer composition is adapted to bind or otherwise be selectively disturbed by one or more analytes (the sensing layer adapted to bind or otherwise be selectively disturbed by one or more analytes within the animal health test sample composition. Para. [0003]),
wherein the sensor system is configured to detect and quantify one or more analytes present in a target sample (A portable interferometric system for detection and quantification of analyte within an animal health test sample composition is provided. Para. [0003]), and
wherein the target sample handling system and interferometric system are in liquid communication with one another (…the method further includes the step of introducing the target sample to the interferometric system 1206…According to one embodiment, the injection device may be permanently attached to the cartridge system. Para. [0175]).
Regarding claim 12, Levin discloses the claimed invention as discussed above in claim 9. Levin teaches sensor system configured to detect and quantify one or more analytes in situ and provide analyte quantity in real-time or near real-time (…The systems as provided herein may provide both qualitative and quantitative results from one or more analytes within a test sample composition. Particularly, the systems as provided herein may simultaneously provide detection and quantification of one or more analytes from a target sample. According to one embodiment, both qualitative and quantitative results are provided in real-time or near real time. Para. [0059]).
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell (Planar-Waveguide Interferometers for Chemical Sensing).
Regarding claim 1, Campbell discloses a sensing layer composition comprising:
a charge transfer complex (iodine complex with the aromatic styrene) comprising an electron acceptor (iodine/iodide) and at least one aromatic hydrocarbon (styrene) (para. 3, page 94),
wherein the sensing layer composition is adapted to bind to otherwise be selectively disturbed by one or more analytes (chlorine, para. 3, page 94).
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) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Campbell (Planar-Waveguide Interferometers for Chemical Sensing).
Regarding claim 13, Levin discloses the claimed invention as discussed above in claim 9.
Levin does not disclose the sensing layer composition comprising: a charge transfer complex comprising an electron acceptor and at least one aromatic hydrocarbon.
Levin discloses the system is capable of detect and quantify levels of various chemicals including but not limited to ammonia…chlorine (para. [0169]).
Analogous art, Campbell discloses an iodine/polymer sensing film layer (It is also possible to have the iodide ions in the sensing film, leaving the chlorine to diffuse into the sensing film, convert the iodide to iodine, and to have the iodine complex with the aromatic styrene. Page 94, para. 3) comprising:
a charge transfer complex (iodine complex with the aromatic styrene) comprising an electron acceptor (iodine/iodide) and at least one aromatic hydrocarbon (styrene) (para. 3, page 94).
As both the device of Levin and sensing film of Campbell are configured to detect and quantify chlorine on the surface by using interferometers , it would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the sensor layer of Interferometric chip of Levin to with chlorine-detection iodine/polymer film to derive the claimed invention. Doing so provides the device of Levin with indicator/sensor polymer composition capable of detecting and quantifying chlorine as disclosed by Levin.
Regarding Claim 14, Modified Levin discloses the claimed invention as discussed above in claim 13. Campbell, after incorporation with Levin, discloses the sensing layer composition is formulated as a film (sensing film, Page 94, para. 3).
Claim(s) 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Xu (Free Chlorine sensing using an interferometric sensor, 2011).
Regarding claim 16, Campbell discloses a method of detecting an analyte in a liquid sample (The underlying sensitivity of any of the interferometers described heretofore is dictated by the waveguide’s composition – substrate, waveguide, waveguide thickness, and interaction length – but the ultimate sensitivity of the sensor depends on how well the sensing chemistry can amplify the signature of any compounds present through adsorption or chemical reactions that alter the refractive index of the sensing film. 7 Chemical Sensing – Passive and Active, Page 78, para. 1), the method comprising:
contact the liquid sample (water) with a sensing layer composition of claim 1 (7.2. Active sensing, para. 3, page 94); and
detecting a change in a property (refractive index) of the sensing layer composition caused by interaction of the analyte with the charge transfer complex using an interferometric system (These reactions have been shown to produce large interferometric signals through the formation of a different chemical species within the sensing film that has a substantially different refractive index from those of the starting materials. 7.2. Active sensing, para. 1, page 89).
Campbell does not teach a step of quantifying a concentration based on the detected change. In an analogous art, Xu discloses a method of quantifying the concentration based on the sensor response in a chlorine interferometric sensing method. The quantification method involves constructing a calibration curve between sensor response and chlorine concentration using standard solutions (Under the optimized sensing conditions, a series of standard HOCl solutions were measured and the slopes of the sensing responses were calculated from the sensor responses (Fig. 5) to construct a calibration curve. A linear relationship between the sensor response and the free chlorine concentration between 0.1 ppm and 10 ppm was obtained. Fig. 5, 3.3. Sensitivity, para. 1).
It would have been obvious to one of ordinary skilled in the art before the filing date to have used the method of Campbell on multiple standard solutions to establish a calibration curve as highlighted by procedure of Xu. Doing so allows for a semi-quantitative way of determining concentration of chlorine based on sensor response.
Regarding claim 17, Modified Campbell discloses the claimed invention as discussed above in claim 16. Campbell discloses the property of the sensing layer composition is a change in refractive index (7.2. Active sensing, para. 1, page 89), and
Wherein detecting the change comprises detecting a phase shift in light propagating through one or more waveguide channels of the interferometric system (Chapter 4, Planar-Waveguide Operation, The transverse-resonance condition states that a guided beam must experience a 2π phase shift between equivalent points in the cycle of propagation and reflections in the ray trace translating along the waveguide. Figure 1 shows one of these cycles that represent the 2π phase shift between equivalent points (first and last ray arrows). Para. 1; and Fig. 1, page 61).
Regarding claim 18, Modified Campbell discloses the claimed invention as discussed above in claim 17. Campbell discloses the sensing layer composition is formulated as a film (sensing film, Page 94, para. 3) adhered to at least one side of the one or more waveguide channels in a waveguide chip of an optical interferometric system (Planar waveguides are composed of thin films of a transparent dielectric material with a higher index of refraction… 4. Planar-Waveguide Operation, para. 1, page 61).
Regarding claim 20, Modified Campbell discloses the claimed invention as discussed above in claim 16. Campbell discloses the electron acceptor comprises iodine and the at least one aromatic hydrocarbon comprises a styrene-containing polymer (para. 3, page 94),
And wherein the charge transfer complex is configured to produce a measurable change in refractive index upon interaction with the analyte (These reactions have been shown to produce large interferometric signals through the formation of a different chemical species within the sensing film that has a substantially different refractive index from those of the starting materials. 7.2. Active Sensing, para. 1, page 89).
Allowable Subject Matter
Claim(s) 10 and 19 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 19, Modified Campbell discloses the claimed invention as discussed above in claim 16. Neither Campbell nor Xu explicitly discloses the detecting the change comprises selectively detecting the peracetic acid in the liquid sample without cross-reactive interference from hydrogen peroxide present in the liquid sample as the method is used for chlorine detection.
Though arts like Warburton (US 10837949 B1) discloses a peracetic acid sensor without detecting hydrogen peroxide (Abstract), the method of Warburton is a gas vapor sensor with a filter that removes hydrogen peroxide before detection.
As such, one of ordinary skilled in the art would not be able to derive a method of using interferometer of Campbell for detecting peracetic acid in the liquid sample without interference from hydrogen peroxide present in the liquid sample.
Regarding claim 10, Applicant’s response, regarding claim 10, is persuasive. Closest prior arts, Campbell discloses an interferometric sensing system for chlorine. There is no evidence that the system is configured to detect peracetic acid.
Response to Arguments
Applicant's arguments filed 09/12/26 have been fully considered but they are not persuasive.
Regarding applicant’s first argument with respect to charge transfer complex on page 6-7, applicant argues that the composition of Wu is used for colorimetric analysis, yet the claimed invention is for redox despite sharing similar iodide and certain aromatic polymer in the composition. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The sensing composition of claim 1, under broadest reasonable interpretation, simply requires a composition to have two components (can be a powder, dry mixture, wet mixture, etc.), neither does the claim explicitly require the composition to bind by one or more analytes in a redox reaction.
Regarding applicant’s argument and remark on intended use, for claim 4, MPEP states “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original)” and “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. Furthermore, Wu discloses “the results set forth in Tables 1 and 2 show that a test strip of the present invention is capable of assaying for hydrogen peroxide over the entire range of 0% to greater than 4% by weight, and for peracetic acid over the entire range of 0 to 2000 ppm, by providing a differentiable color response over these entire ranges. Accordingly, a single test strip can be used to assay for a low or a high concentration of peroxide, without diluting the test sample” which implies there is differentiable color change between peroxide and peracetic acid; this would satisfy the limitation “without interference”.
Regarding applicant’s third argument with respect to claim 5-6, Examiner respectfully disagreed with applicant’s assertion. In the absence of specification language supporting a narrower interpretation, the patent claim terms “configured to” and “configured for” are properly construed to mean “capable of” performing the recited function. The composition in question is merely a mixture (wet, dry, etc.). There are no structural features for the composition (like a film) that explicitly allow the mixture to be applied on the specific device. In addition, the device is not a recited structure of the claim, the claim at best is interpreted to be a manner of operation rather than a feature that provides structure to the composition.
In response to applicant's argument that Campbell is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, applicants rely on an embodiment of Levin being used as an animal health biosensor for detecting antibodies, viruses, and pathogens (para. [0107]) yet disregard another embodiment that Levin’s device can be configured to detect the surrounding environment of animal for non-organic substances (para. [0169]). As such, at least one of Levin’s embodiments and Campbell are indeed analogous.
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.
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/M.H./ Examiner, Art Unit 1758 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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