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 .
Status of Claims
Applicant's arguments, filed 04/15/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim 24 continues to be withdrawn per applicant's election of restriction requirement filed on 08/01/2025.
Applicants have amended their claims, filed 04/15/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-23 and 36 are the current claims hereby under examination.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 06/27/2023 and 07/03/2024 are in compliance with the provision of 37 CFR 1.97. Accordingly, the IDS are being considered.
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) 1-2, 4-9, 11-23, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortellaro et al. (US Patent Pub. No. 20200178854 – previously cited) hereinafter Mortellaro 1.
Regarding Claim 1, Mortellaro 1 discloses a sensor for measurement of an analyte in a medium within a living animal (the sensor 100 may be an implantable sensor configured to be fully or partially implanted in a living animal (e.g., a living human) [0046]; the sensor 100 may include an analyte indicator 106 [0052]; fig 1), the sensor comprising:
a sensor housing (the sensor 100 may include a sensor housing 102 [0051]; fig 1);
an analyte indicator covering at least a portion of the sensor housing (the analyte indicator 106 may be a polymer graft coated, diffused, adhered, or embedded on at least a portion of the exterior surface of the sensor housing 102. The analyte indicator 106 (e.g., polymer graft) may cover the entire surface of sensor housing 102 or only one or more portions of the surface of housing 102… the analyte indicator 106 may be a hydrogel [0052]; fig 1);
and a protective system including multiple metals configured to reduce deterioration of the analyte indicator (the sensor 100 may include a multiple metal protective system that includes multiple protective metals… the multiple metals may reduce deterioration of the analyte indicator 106 [0072]; fig 1);
wherein the protective system includes first and second metal layers (the multiple metal protective system may include a first metal layer 800 and a second metal layer 801 [0075]; fig 4A), the first metal layer covers at least a portion of the analyte indicator and includes a first metal of the multiple metals (as shown in FIG. 4A, the first metal layer 800 may cover at least a portion of the analyte indicator 106 [0075]), the second metal layer covers at least a portion of the first metal layer and includes a second metal of the multiple metals (the second metal layer 801 may cover at least a portion of the first metal layer 800 [0075]; fig 4A), and the first and metals are different (the first metal and the second metal may be different metals [0077]).
Mortellaro 1 fails to disclose the protective system includes a third metal layer, the third metal layer covers at least a portion of the second metal layer and includes a third metal of the multiple metals, and the first, second, and third metals are different.
It is noted that Applicant has failed to provide has failed to provide details of criticality or unexpected results in the Specification with regard to the claimed third metal layer. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the sensor of Mortellaro 1 such that the protective system includes a third metal layer with the third metal layer covers at least a portion of the second metal layer and includes a third metal of the multiple metals, and the first, second, and third metals are different, in the same manner that the second metal layer covers at least a portion least a portion of the first metal layer and includes a second metal of the multiple metals and the first and metals are different, as taught by Mortellaro 1. The mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
Regarding Claim 2, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the first metal is platinum (the first metal may be platinum [0077]).
Regarding Claim 4, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the second metal is tungsten (the second metal may be tungsten [0077]).
Regarding Claim 5, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the second metal is cobalt (the second metal layer 801 may include a second metal selected from Mo, W, Cu, Fe, Co [0077]).
Regarding Claim 6, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the third metal is molybdenum. However, Mortellaro 1 discloses the second metal can be molybdenum (the second metal may be molybdenum [0077]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the third metal is molybdenum because Mortellaro 1 discloses molybdenum is a suitable choice of metal for a metal layer. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding Claim 7, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the first metal layer is sputtered on the analyte indicator (A non-limiting example of a sensor (“Example Sensor 1”) includes a sensor housing, a hydrogel on at least a portion of the sensor housing, indicator molecules contained in the hydrogel, and Pt sputtered on at least a portion of the hydrogel [0094]).
Regarding Claim 8, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the second metal layer is sputtered on the first metal layer. However, Mortellaro 1 discloses the first metal layer is sputtered on the analyte indicator (A non-limiting example of a sensor (“Example Sensor 1”) includes a sensor housing, a hydrogel on at least a portion of the sensor housing, indicator molecules contained in the hydrogel, and Pt sputtered on at least a portion of the hydrogel [0094]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the second metal layer is sputtered on the first metal layer because Mortellaro 1 discloses sputtering can be used to deposit metal layers. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 9, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the third metal layer is sputtered on the second metal layer. However, Mortellaro 1 discloses the first metal layer is sputtered on the analyte indicator (A non-limiting example of a sensor (“Example Sensor 1”) includes a sensor housing, a hydrogel on at least a portion of the sensor housing, indicator molecules contained in the hydrogel, and Pt sputtered on at least a portion of the hydrogel [0094]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the third metal layer is sputtered on the second metal layer because Mortellaro 1 discloses sputtering can be used to deposit metal layers. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 11, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses, an in vivo catalytic activity of the first metal layer and the second metal layer covering the first metal layer is greater than an in vivo catalytic activity of the first metal layer alone (In an assay, protective activities listed in Table 2 were found against hypochlorite. [0090]; Unexpectedly, Au, Pd, Ni, Ta, Mg, Pt, Pt/Rh, Pt/Ir had no detectable activity against hypochlorite. [0091]; Examiner notes that platinum had no catalytic activity against hypochlorite, but copper, tungsten, iron, molybdenum, and cobalt all did. Therefore, if the first metal layer is composed of platinum and the second metal layer is composed of copper, tungsten, iron, molybdenum, or cobalt, then the in vivo catalytic activity of the first metal layer and the second metal layer covering the first metal layer is greater than an in vivo catalytic activity of the first metal layer alone).
Regarding Claim 12, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 does not explicitly discloses the second metal layer is less susceptible to catalytic inactivation via thiol-containing molecules than the first metal layer is susceptible to catalytic inactivation via thiol-containing molecules. However, Mortellaro 1 discloses the first metal layer is platinum (the first metal may be platinum [0077]) and the second metal layer is copper (the second metal layer 801 may include a second metal selected from Mo, W, Cu, Fe, Co [0077]).
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."). Furthermore, Applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by Mortellaro 1. In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). As such, Mortellaro 1 discloses all of the limitations of claim 12.
Regarding Claim 13, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the third metal layer covering at least the portion of the second metal layer has greater adhesion to the second metal layer than the third metal layer would have if the third metal layer were instead applied directly to the first metal layer or the analyte indicator. However, Mortellaro 1 discloses the second metal layer covering at least the portion of the first metal layer has greater adhesion to the first metal layer than the second metal layer would have if the second metal layer were instead applied directly to tthe analyte indicator, and doing so would improve protection against degradative species (In some embodiments, the multiple metals (e.g., in one or more metal layers on the analyte indicator 106 and/or one or more metal particles incorporated in the analyte indicator 106) in the multiple metal protective system may additionally or alternatively improve protection against degradative species because one metal layer (e.g., the first metal layer 800) may act to promote adhesion of another metal layer (e.g., the second metal layer 801). For example, molybdenum may adhere better to platinum than to an analyte indicator 106, which may be, for example and without limitation, a glucose indicating hydrogel than molybdenum. For instance, in the embodiments shown in FIGS. 4A, 7A, and 10A, the multiple metal protective system may include a first metal layer 800 applied to at least a portion of the analyte indicator 106 and a second metal layer 801 applied to at least a portion of the first metal layer 800, and the first and second metal layers 800 and 801 may include first and second metals (e.g., platinum and molybdenum), respectively. In some embodiments, the first metal (e.g., platinum) of the first metal layer 800 may promote adhesion of the second metal of the second metal layer 801. That is, the second metal layer 801 may adhere better to the first metal layer 800 than the second metal layer 801 would adhere to the analyte indicator 106 if applied directly to the analyte indicator 106. Accordingly, the multiple metals of the multiple metal protective system may allow the system to include a metal that could not be used if only one metal were used. In some non-limiting embodiments, the multiple metal protective system may include a Pt layer covered by a Mo layer, which may enable improved adhesion to the hydrogel and improve catalysis against both hydrogen peroxide and hypochlorite. [0093]).
The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the third metal layer covering at least the portion of the second metal layer has greater adhesion to the second metal layer than the third metal layer would have if the third metal layer were instead applied directly to the first metal layer or the analyte indicator, because doing so would enable improved catalysis of the degradative species of choice.
Regarding Claim 14, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the third metal is catalytically active against a degradative species that the first and second metals are not active against. However, Mortellaro discloses “the multiple metals (e.g., in one or more metal layers on the analyte indicator 106 and/or one or more metal particles incorporated in the analyte indicator 106) in the multiple metal protective system may improve protection against degradative species because one of the metals may degrade one type of degradative species (e.g., hydrogen peroxide) and another one of the metals may degrade another type of degradative species (e.g., hypochlorite)” [0092].
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the third metal is catalytically active against a degradative species that the first and second metals are not active against because Mortellaro 1 discloses different metals may be catalytically active against different degradative species. Doing so would improve the protective system of the sensor because it would protect the sensor from more/different degradative species.
Regarding Claim 15, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the third metal is catalytically active against hypochlorous acid, and the first and second metals are not active against hypochlorous acid. However, Mortellaro 1 discloses “platinum can be used to degrade hydrogen peroxide but is not useful to degrade hypochlorite… copper was found to be more reactive than molybdenum against hydrogen peroxide but less reactive than molybdenum against hypochlorite” [0091].
The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the first metal is platinum, the second metal is copper, and third metal is molybdenum because Mortellaro 1 discloses platinum, copper, and molybdenum as a suitable choice of metal for a metal layer. As such, the third metal is catalytically active against hypochlorous acid, and the first and second metals are not active against hypochlorous acid.
Regarding Claim 16, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the first, second, and third metals are catalytically active against hydrogen peroxide. However, Mortellaro 1 discloses “the first metal layer 800 may include a first metal selected from Cu, W, Pt, Fe, Mo, Co” [0077] and “the second metal layer 801 may include a second metal selected from Mo, W, Cu, Fe, Co” [0077]. Mortellaro 1 also discloses the protective properties of select metals (In an assay, protective activities listed in Table 1 were found against hydrogen peroxide. [0088]; Examiner notes that copper, tungsten, platinum, iron, molybdenum, and cobalt are all catalytically active against hydrogen peroxide).
Since all the suitable metals, taught by Mortellaro 1, for the metal layers are catalytically active against hydrogen peroxide, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the first, second, and third metals are selected from Mo, W, Cu, Fe, Co. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07. Modified Mortellaro 1 teaches the first, second, and third metals are catalytically active against hydrogen peroxide
Regarding Claim 17, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 fails to disclose the third metal is catalytically active against multiple reactive oxygen species. However, Mortellaro 1 teaches “the second metal layer 801 may include a second metal selected from Mo, W, Cu, Fe, Co” [0077] and the protective properties of select metals (In an assay, protective activities listed in Table 1 were found against hydrogen peroxide. [0088]; In an assay, protective activities listed in Table 2 were found against hypochlorite. [0090]; Examiner notes that copper, tungsten, iron, molybdenum, and cobalt are all catalytically active against hydrogen peroxide and hypochlorite which are reactive oxygen species).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified Mortellaro 1 such that the third metal is selected from Mo, W, Cu, Fe, Co, as taught by Mortellaro 1. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07. Modified Mortellaro 1 teaches disclose the third metal is catalytically active against multiple reactive oxygen species.
Regarding Claim 18, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the first metal layer does not include the second metal and the second metal layer does not include the first metal (In some embodiments, the first metal and the second metal may be different metals. In some non-limiting embodiments, the first metal may be platinum, and the second metal may be molybdenum. In some non-limiting embodiments, the first metal may be copper, and the second metal may be molybdenum. In some non-limiting alternative embodiments, the first metal may be platinum, and the second metal may be tungsten. In some other non-limiting alternative embodiments, the first metal may be tungsten, and the second metal may be molybdenum. In some other non-limiting alternative embodiments, the first metal layer 800 includes platinum and the second metal layer 801 includes tungsten. [0077]; In some embodiments, metal particles 802 may be incorporated into a first carrier material 811 and different metal particles 803 may be incorporated into a second carrier material 812, wherein the first carrier material 811 covers the analyte indicator 106 as shown in FIG. 16C. [0086]; fig 16C). However, Mortellaro 1 fails to disclose the first metal layer does not include the second and third metals, the second metal layer does not include the first and third metals, and the third metal layer does not include the first and second metals.
Since modified Mortellaro 1 teaches a third metal layer composed of a third metal, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the first metal layer does not include the second and third metals, the second metal layer does not include the first and third metals, and the third metal layer does not include the first and second metals in the same manner that the first metal layer does not include the second metal and the second metal layer does not include the first metal, as taught by Mortellaro 1. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 19, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the protective system comprises metal particles incorporated within the analyte indicator, and the metal particles include one or more of the multiple metals (the multiple metals (e.g., in one or more metal layers on the analyte indicator 106 and/or one or more metal particles incorporated in the analyte indicator 106) in the multiple metal protective system [0092]).
Regarding Claim 20, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the first metal layer is a multi-metal layer comprising two or more of the multiple metals (In some non-limiting embodiments, the first metal layer 800 may include a first metal selected from Cu, W, Pt, Fe, Mo, Co, and oxides, alloys, and complexes of those metals (e.g., alloys such as Pt/Rh and Pt/Lr). In some non-limiting embodiments, the first metal layer 800 may include the first metal and one or more additional metals selected from Cu, W, Pt, Fe, Mo, Co, and oxides, alloys, and complexes of those metals. [0077]).
Regarding Claim 21, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the multiple metals are configured to collectively interact or react with multiple degradative species (the protective system may include multiple metals that are configured to collectively interact or react with multiple degradative species [0014]).
Regarding Claim 22, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses the multiple metals of the protective system are configured to collectively interact or react with at least two of hydrogen peroxide, a reactive oxygen species, enzymes, metal ions, a reactive nitrogen species, and a free radical (the multiple metals of the protective system may be configured to collectively interact or react with at least two of hydrogen peroxide, a reactive oxygen species, enzymes, metal ions, a reactive nitrogen species, and a free radical. [0014]).
Regarding Claim 23, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 further discloses a radiation source contained in the sensor housing and configured to emit radiation to the analyte indicator (the sensor 100 may include a light source 108, which may be, for example, a light emitting diode (LED) or other light source that emits radiation, including radiation over a range of wavelengths that interact with the indicator molecules 104 [0054]; Some part of the excitation light 329 emitted by the light source 108 may be reflected from the analyte indicator 106 [0056]; fig 1); and a photosensitive element contained in the sensor housing and configured to receive light emitted by the analyte indicator (Some part of the excitation light 329 emitted by the light source 108 may be reflected from the analyte indicator 106 back into the sensor 100 as reflection light 333, and some part of the absorbed excitation light may be emitted as emitted (fluoresced) light 331... The reflected light 333 and emitted (fluoresced) light 331 may be absorbed by the one or more photodetectors (e.g., first and second photodetectors 224 and 226) within the body of the sensor 100. [0056]; fig 1).
Regarding Claim 36, Mortellaro 1 discloses a method (the present invention relates to a method for detecting the presence or concentration of an analyte in an in vivo sample [0044]) comprising:
exposing an in vivo sample to a device having a detectable quality that changes when the device is exposed to an analyte of interest (exposing the in vivo sample to a device having a detectable quality that changes when the device is exposed to an analyte of interest [0044]), wherein the device comprises protective material that prevents or reduces degradation or interference of the device from degradative species or biological oxidizers (The device includes in part protective material, wherein the protective material prevents or reduces degradation or interference of the device from degradative species or biological oxidizers. [0044]), and wherein the device is the sensor of claim 1 (see rejection of claim 1 above);
measuring a change in the detectable quality to thereby detect a presence or concentration of the analyte of interest in the in vivo sample (measuring any change in the detectable quality to thereby determine the presence or concentration of an analyte of interest in the in vivo sample [0044]).
Claim(s) 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortellaro 1 (US Patent Pub. No. 20200178854 – previously cited) as applied to claim 1 above, and further in view of Mortellaro et al. (US Patent Pub. No 20190159708 – previously cited) hereinafter Mortellaro 2.
Regarding Claim 3, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Modified Mortellaro 1 fails to teach the second metal is iridium.
However, Mortellaro 2 teaches iridium as a suitable metal to protect an analyte indicator (In some embodiments, the coating 207 may include a catalytically active material configured to reduce deterioration of the analyte indicator 106 by catalyzing degradation of reactive oxygen species (ROS). In some embodiments, the catalytically active material in the coating may include, for example and without limitation, one or more of platinum, iridium, palladium, manganese oxide, thiol and/or disulfide containing compounds, and catalase. In some non-limiting embodiments, the coating 207 may be a sputter coating sputtered on the outside of the analyte indicator 106. [0061]).
Mortellaro 2 is considered analogous art to the present invention because it directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the second metal is iridium, as taught by Mortellaro 2, because it is a catalytically active material suitable to protect the analyte indicator. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding Claim 10, modified Mortellaro 1 teaches the invention as discussed above in claim 1. Mortellaro 1 discloses the first metal layer is a layer of platinum sputtered on the analyte indicator (A non-limiting example of a sensor (“Example Sensor 1”) includes a sensor housing, a hydrogel on at least a portion of the sensor housing, indicator molecules contained in the hydrogel, and Pt sputtered on at least a portion of the hydrogel [0094]) and “the second metal layer 801 may include a second metal selected from Mo, W, Cu, Fe, Co” [0077]. However, Mortellaro 1 fails to disclose the first metal layer is a layer of platinum having a thickness greater than or equal to 7nm and less than or equal to 13nm sputtered on the analyte indicator, the second metal layer is a layer of iridium having a thickness greater than or equal to 3nm and less than or equal to 7nm sputtered on the first metal layer, and/or the third metal layer is a layer of molybdenum having a thickness greater than or equal to 17nm and less than or equal to 23nm sputtered on the second metal layer.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the third metal layer is a layer of molybdenum because Mortellaro 1 discloses molybdenum is a suitable choice of metal for a metal layer. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Modified Mortellaro 1 fails to disclose the first metal layer is a layer of platinum having a thickness greater than or equal to 7nm and less than or equal to 13nm sputtered on the analyte indicator, the second metal layer is a layer of iridium having a thickness greater than or equal to 3nm and less than or equal to 7nm sputtered on the first metal layer, and/or the third metal layer is a layer of molybdenum having a thickness greater than or equal to 17nm and less than or equal to 23nm sputtered on the second metal layer.
However, Mortellaro 2 teaches iridium as a suitable metal to protect an analyte indicator (In some embodiments, the coating 207 may include a catalytically active material configured to reduce deterioration of the analyte indicator 106 by catalyzing degradation of reactive oxygen species (ROS). In some embodiments, the catalytically active material in the coating may include, for example and without limitation, one or more of platinum, iridium, palladium, manganese oxide, thiol and/or disulfide containing compounds, and catalase. In some non-limiting embodiments, the coating 207 may be a sputter coating sputtered on the outside of the analyte indicator 106. [0061]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 such that the second metal layer is a layer of iridium, as taught by Mortellaro 2, because it is a catalytically active material suitable to protect the analyte indicator. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Modified Mortellaro 1 in view of Mortellaro 2 fails to disclose the first metal layer is a layer of platinum having a thickness greater than or equal to 7nm and less than or equal to 13nm sputtered on the analyte indicator, the second metal layer is a layer of iridium having a thickness greater than or equal to 3nm and less than or equal to 7nm sputtered on the first metal layer, and/or the third metal layer is a layer of molybdenum having a thickness greater than or equal to 17nm and less than or equal to 23nm sputtered on the second metal layer.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the sensor of Mortellaro 1 in view of Mortellaro 2 such that the second metal layer is sputtered on the first metal layer and the third metal layer is sputtered on the second metal layer because Mortellaro 1 discloses sputtering can be used to deposit metal layers. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Modified Mortellaro 1 in view of Mortellaro 2 fails to disclose the first metal layer is a layer of platinum having a thickness greater than or equal to 7nm and less than or equal to 13nm sputtered on the analyte indicator, the second metal layer is a layer of iridium having a thickness greater than or equal to 3nm and less than or equal to 7nm sputtered on the first metal layer, and/or the third metal layer is a layer of molybdenum having a thickness greater than or equal to 17nm and less than or equal to 23nm sputtered on the second metal layer.
It is noted that Applicant has failed to provide has failed to provide details of criticality or unexpected results in the Specification with regard to the claimed thickness of the first, second, and third metal layers. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimum thickness for the first, second, and third metal layers. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments, see page 8 of Remarks, filed 04/15/2026, with respect to the claim objections have been fully considered and are persuasive. The objection of claim 23 has been withdrawn.
Applicant’s arguments, see pages 8-9 of Remarks, filed 04/15/2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of claims 13 and 36 have been withdrawn.
Applicant's arguments, see pages 9-16 of Remarks, filed 04/15/2026, with respect to the 35 U.S.C. rejections have been fully considered but they are not persuasive.
Regarding independent claims 1 and 24, Applicant argues “the cited references do not disclose and would not have suggested ‘protective system’” as detailed in claim 1 because adding a third metal layer that is different than the second metal of the second metal layer would not be a mere duplication of parts. Examiner respectfully disagrees. Mortellaro 1 discloses in non-limiting embodiments “a multiple metal protective system that includes multiple protective metals” [0072], “the multiple metal protective system may include (i) one or more metal layers on or in proximity to the analyte indicator 106” [0078], and “the first and second metals may be different metals” [0078]. Therefore, the protective system of Mortellaro 1 can have three multiple metal layers that may be three different metals. There is no new and unexpected result when Mortellaro 1 is modified to include a third metal layer that would cover at least a portion of the second metal layer and the third metal is different than the second metal. This modification is considered a duplication of parts because the third metal layer is duplicated in the same manner as the second metal layer. The second metal layer covers at least a portion of the first metal layer, as seen in figure 4A. Therefore, a third metal layer would cover at least a portion of the metal layer below it. Since the first metal layer is already covered by the second metal layer, as seen in figure 4A, the third metal would expectedly be added on top to cover at least a portion of the second metal layer. Furthermore, Mortellaro 1 discloses a plurality of metals that can be used in the multiple metal layers and the first and second metals may be different. Therefore, a third metal layer may include a third metal listed in the plurality of metals and the third metal may be different than the second metal. Duplicating a third metal layer in the same manner as the second metal layer does not produce a new and unexpected result. This proposed modification does not rely on information gleaned only from Applicant’s disclosure because Mortellaro 1 discloses multiple metal layers that may be comprised of different metals.
Regarding claim 3, Applicant argues Mortellaro 2 discloses an iridium coating is applied directly to the analyte indicator but does not disclose or suggest “including iridium in a second metal layer that covers at least a portion of a first metal layer and that at least a portion thereof is covered by a third metal layer”. Examiner respectfully disagrees. Mortellaro 2 is only used to show that iridium is a suitable metal to protect an analyte indicator [0061]. The prior art rejection of claim 1 teaches a second metal layer that covers at least a portion of a first metal layer and that at least a portion thereof is covered by a third metal layer, as discussed above. Mortellaro 2 does not need to disclose different metal layers or any structural components because it is only used to teach that iridium is a suitable known material for the intended use. Therefore, modified Mortellaro 1 is further modified such that the second metal is iridium, as taught by Mortellaro 2, because the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding claim 10, Applicant argues that neither Mortellaro 1 nor Mortellaro 2 disclose including iridium in a second metal layer that covers at least a portion of a first metal layer and that at least a portion thereof is covered by a third metal. For the reasons set forth above with respect to claim 3, Examiner respectfully disagrees. Applicant also argues that Mortellaro 1 does not disclose or suggest a layer of molybdenum that covers at least a portion of a second metal layer. However, the prior art rejection of claim 1 teaches a third metal layer that covers at least a portion of a second metal layer, as discussed above. Mortellaro 1 also teaches that molybdenum is a suitable metal to be used in a protective system for an analyte indicator [0077]. Therefore, modified Mortellaro 1 is further modified such that the third metal layer is a layer of molybdenum, as taught by Mortellaro 1, because the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Applicant's arguments, see pages 16-17 of Remarks, filed 04/15/2026, with respect to the rejoinder have been fully considered but they are not persuasive. Claim 1 is not allowable. Therefore, there will be no rejoinder of withdrawn claim 24.
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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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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