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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Status of Claims
Claims 1-36 are currently pending. Claims 1-3 and 5 have been amended by Applicants’ amendment filed 11-14-2025. No claims have been added or canceled by Applicants’ amendment filed 11-14-2025.
Applicant's election without traverse of Group I, claims 1-5 directed to an analyte sensor, in the reply filed on April 17, 2025, and Applicant’s electronic mail received March 9, 2025 are acknowledged.
Applicant's election without traverse of Group I, claims 1-5, directed to an analyte sensor; and
Species (A): wherein the structure of the analyte sensor is as follows:
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, wherein: X is alkyl (CH3); Z is O; W is alkyl hydroxy (OCH2CH2OH); n>1; the working electrode is a platinum electrode; the membrane is formed via a polymer of ethylenically unsaturated silicone prepolymer, wherein the ethylenically unsaturated silicone prepolymer is vinyl terminated polydimethylsiloxane; the hydride silicone prepolymer is poly(methylhydrosiloxane); the non-silicone ethylenically unsaturated hydrophilic monomer is 2-hydroxyethyl methacrylate; the filler is silicon dioxide;
the metal catalyst is platinum-cyclovinylmethyl-siloxane complex (claim 1);
Species (B): wherein the species of non-silicone ethylenically unsaturated hydrophilic monomer is 2-hydroxyethyl methacrylate, 3-hydroxypropyl methacrylate…or acrylic acid (claim 3); and
Species (C) - (G): Applicant asserts that these species are rendered moot, in the reply filed April 17, 2025, and electronic mail received by the Examiner on March 9, 2025.
Claims 6-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement is deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Therefore, claims 1-3 and 5 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed November 29, 2021 is a CON of US Patent Application 17/136,178, filed December 29, 2020, which claims the benefit of US Provisional Patent Application 62954793, filed December 30, 2019.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application 62/954793, filed December 30, 2019, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. The specific method steps recited in independent claim 1 does not have support for: a ethylenically unsaturated silicone prepolymer; a metal catalyst; a hydride silicone prepolymer; a filler; and the structure
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including all designations for Z, W and n. Therefore, the priority date for the presently claimed invention is November 29, 2021, the filing date of US Patent Application 17/537,310.
Applicants are invited to specifically indicate the location of the cited phrase pertinent to claim 1 of the instant application.
Response to Arguments
Applicant’s remarks filed November 14, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) support for the current claims can be found in paragraphs [0042]-[0044], [0051] and [0054] of the ‘793 application (Applicant Remarks, pg. 9, last full paragraph).
Regarding (a), it is noted that: (a) paragraphs [0042]-[0044] of the US Provisional Application 62/954793 teaches definitions for silicone, ethylenically unsaturated, and HEMA; (b) paragraph [0051] teaches a method of making an analyte sensor comprising a sensing layer, coupling agent, ethylenically unsaturated functional groups, and curing at a temperature range of 4-80oC, where the membrane is prepared from a polyelectrolyte mixed with an enzyme and a crosslinker reacted with an ethylenically unsaturated prepolymer; and (c) paragraph [0054] teaches what an ethylenically unsaturated hydrophilic monomer can be comprised of. It is noted that the specific method steps recited in independent claim 1 does not have support for: a ethylenically unsaturated silicone prepolymer; a metal catalyst; a hydride silicone prepolymer; a filler; and the structure
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including all designations for Z, W and n. Thus, the priority date for the presently claimed invention is November 29, 2021.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed November 14, 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
Claim Rejections - 35 USC § 112(d)
The rejections of claims 2, 3 and 5 is withdrawn under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends due to Applicant’s amendment of the claims, in the reply filed November 14, 2025.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Claim Rejections - 35 USC § 102
The rejection of claims 1-3 and 5 is withdrawn under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Wang et al. (hereinafter “Wang”) (US Patent Application Publication 20110152654, published June 23, 2011).
Wang does not specifically exemplify the structure of the membrane formed in claim 1.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Maintained Objections/Rejections
Product-by-Process
Instant claims 1-3 and 5 are determined to be product-by-process claims. The structural elements of the product, comprising: a working electrode, a glucose and oxygen permeable membrane disposed over the working electrode having the structure
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, where X is H or alkyl; Z is a single =O moiety; W is OH, O-alkyl, O-alkylhydroxy, O-alkoxy, O-methacrylate, or O-acrylate; and n is >1, wherein the membrane is prepared by the method as recited in claim 1 is not considered to limit the analyte sensor of claim 1, such that it is assumed that an equivalent analyte sensors are obtainable by multiple routes. The burden is placed upon the applicants to establish a patentable distinction between the claimed and referenced products. Moreover, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
Specification Objection
The objection to the disclosure is maintained because of the following informalities: the Specification, filed November 29, 2021, comprises the teaching that “Z is O, H2” such as in paragraphs [0029] and [0087]. Although the structure of C=O is proper, C=H2 is not an appropriate chemical structure.
Appropriate correction is required.
The objection to the disclosure is maintained because of the following informalities: the Specification, filed November 29, 2021, comprises the structure
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such as in paragraphs [0029] and [0087]. It is unclear whether the bond to “Z” is a double bond or a bond comprising a dashed line (indicating that it can be a single bond or a double bond).
Appropriate correction is required.
Response to Arguments
Applicant’s remarks filed November 14, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) the objections to the Specification are moot in view of the claim amendments (Applicant Remarks, pg. 9, last partial paragraph through pg. 10, first full paragraph).
Regarding (a), the Examiner respectfully notes that the objection to the Specification can be overcome by amending the as-filed Specification. Amendments to the claims filed 11-14-2025 do not correct the as-filed Specification. Thus, the objections are maintained.
Drawing Objection
The objection to the drawings is maintained as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description:
Figure 3: Figure 3 comprises structures, metals, and a crosslinked hydrophile-modified gel that are not mentioned and/or identified in the description, filed November 29, 2021.
Figure 4: Figure 4 comprises structures that are not identified in the description, filed November 29, 2021.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant’s remarks filed November 14, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) Figure 3 shows the hydrosilylation reaction between vinyl silicone prepolymers and ethylenically unsaturated monomers as described in paragraph [0060] (Applicant Remarks, pg. 11, first full paragraph); and (b) Figure 4 shows non-silicone ethylenically unsaturated monomers and their silicone products, such as described at paragraph [0061] of the current Specification
Regarding (a) and (b), the compounds of Figures 3 & 4 appear to illustrate vinyl silicone prepolymer reactions with a hydrophile-modified silicone having the structure taught in paragraph [0087] of the as-filed Specification, and not hydrosilylation reactions with ethylenically unsaturated monomers as suggested in paragraphs [0060] and [0061]. Moreover, Figures 3 & 4 comprise undefined components Y, M, and R; and Figure 3 refers to the “hydrosilyation reaction”. Thus, the objection is maintained.
Double Patenting
The provisional rejection of claims 1-3 and 5 is maintained on the ground of nonstatutory double patenting as being unpatentable over: claims 1-7, 9, 10, 12-15 and 26-28 of U.S. Patent Application 17/136,178, for the reasons of record.
Response to Arguments
Applicant’s remarks filed November 14, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) the present application is patentably distinct from the claims of the ‘178 application including for the structure of the membrane (Applicant Remarks, pg. 11, last partial paragraph through pg. 12, first full paragraph).
Regarding (a), the membrane recited in claim 1 of US Application 17/136,178 comprises a hydrophilic sensing layer made from a polyelectrolyte prepolymer and an enzyme disposed over the working electrode, and a hydrophobic layer disposed over the hydrophilic sensing layer. Applicant is reminded that the patentability of a product does not depend on its method of production. The instant as-filed Specification teaches the curing process recited in claim 1, and also teaches: “disposing a sensing layer on a surface, applying a membrane over the sensing layer by coating with a silicone solution” (paragraph [0085]). Thus, claim 1 of US17/136178 encompasses the structure of the instant membrane. Thus, the provisional rejection is maintained.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-3 and 5 is maintained under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is indefinite for the recitation of the term “a membrane disposed over said working electrode” and “the membrane…permeable to glucose and oxygen” such as recited in lines 3 and 11-13 because it is unclear how the sensor recited in claim 1 detects an analyte without a “sensing layer.” The instant as-filed Specification teaches that the analyte limiting membrane is applied over a “sensing layer” (see, paragraphs [0030], [0045] and [0085]), which is not recited to be present in the structure of claim 1 and, thus, the metes and bounds of the claim cannot be determined.
The rejection of claim 1 is maintained as being indefinite for the recitation of the structure
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in claim 1, line 14 because it is unclear whether the structure of the silicone composition is bound to a surface (e.g., the surface of the electrode) since there is no indicator showing whether the membrane is bound to a surface (e.g.,
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), such as through the silicone, through a carbon-silicon bond, an oxygen-silicone bond, Z, X, or through W (see; as-filed Specification, paragraph [0095]) and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of the term “the structure” such as recited in claim 1, line 13. There is insufficient antecedent basis for the term “the structure” in the claim.
Claims 2, 3 and 5 are indefinite insofar as they ultimately depend from instant claim 1.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3 and 5 is maintained under 35 U.S.C. 103 as being unpatentable over Wang et al. (hereinafter “Wang”) (US Patent Application Publication 20110152654, published June 23, 2011) in view of Risangud et. al. (hereinafter “Risangud”) (The Royal Society of Chemistry, 2015, 5, 5879-5885).
Regarding claims 1 (in part), 2, 3 and 5, Wang teaches and amperometric analyte sensor apparatus comprising: a base layer; a conductive layer disposed on the base layer and comprising a working electrode; an analyte sensing layer disposed on the conductive layer (e.g. one comprising an oxidoreductase such as glucose oxidase); and an analyte modulating layer disposed on the analyte sensing layer (interpreted as an analyte sensor including a glucose sensor; a working electrode; and interpreting the analyte modulating layer as a restrictive layer controlling the flux of oxygen, claim 1) (paragraph [0008], lines 1-8). Wang teaches a hydrophilic polymer comprising a hydrophilic diol or hydrophilic diamine; and a siloxane having an amino, hydroxyl or carboxylic acid functional group at a terminus; with this polymer then blended with a branched acrylate polymer formed from a mixture comprising: a butyl, propyl, ethyl or methyl-acrylate; an amino-acrylate; a siloxane acrylate; and a poly(ethyleneoxide)-acrylate; and additional materials can be included in these polymeric blends (interpreted as a functional group including acrylate, methacrylate, carboxylic acid, and hydroxy; and polyethylene glycol methacrylate, claims 2, 3 and 5) (paragraph [0011]). Wang teaches that the hydrophilic polymer can be a hydrophilic diol, a hydrophilic diamine or a combination thereof, wherein the hydrophilic diol can be a poly(alkylene)glycol, a polyester-based polyol, or a polycarbonate polyol, wherein the term "poly(alkylene)glycol" refers to polymers of lower alkylene glycols such as
poly(ethylene)glycol, poly(propylene)glycol and polytetramethylene ether glycol (PTMEG) (interpreted as hydroxy groups, carbonate groups, polyethylene glycol monomers, claims 2, 3 and 5) (paragraph [0053], lines 1-9). Wang teaches in Figure 3A, an exemplary silicone materials for use with the blended polymer embodiments of the invention, wherein Figure 3B shows exemplary hydrophilic materials for use with the blended polymer embodiments of the invention, Figure 3C shows exemplary hydrophobic materials for use with the blended polymer embodiments of the invention, and Figure 3D shows the exemplary polymerization reaction of an embodiment of a branched acrylate polymer (paragraph [0017]; and Figure 3A). Figure 3A is shown below:
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R = H, CH3, CH2CH3
R’ = H, OH, NH2, CH3, C2H5, C3H7, C2H4OH and C2H4NH2
(interpreted as the structure of the silicon composition recited in claim 1, where X is H, Z is two hydrogen atoms attached by a single bond to the carbon atom, W is O-acrylate or O-methacrylate, and n>1, claims 1-3 and 5) (Figure 3A). Wang teaches that polymerization of the reactants can be carried out in bulk or in a solvent system, use of a catalyst including dibutyltin bis(2-ethylhexanoate), dibutyltin diacetate, triethylamine and combinations thereof (interpreted as a metal catalyst, claim 1) (paragraph [0057], lines 1-6). Wang teaches the incorporation of one or more chain extenders typically providing the resulting biocompatible membrane with additional physical strength (interpreting chain extenders as fillers, claim 1) (paragraph [0056]). Wang teaches hydrolysis of the alkoxy groups to yield organosilicon hydroxides, which condense to form poly(organosiloxanes) (interpreting organosilicon hydroxides as fillers, claim 1) (paragraph [0155]).
Wang does not specifically exemplify the structure recited in claim 1, where Z is a single =O (claim 1, in part).
Regarding claim 1 (in part), Risangud teaches hydrosilylation reaction for the preparation of organo-silicon compounds, in which vinyl groups react with silanes (Si–H) usually catalyzed by late transition metal complexes such as Pt(II) complexes, wherein hydrosilylation of functional methacrylates provides access to functional poly(dimethylsiloxane)s (PDMS), from appropriate hydride terminated and functional PDMS, in very high yielding reactions without the formation of any side products, odor and without the need for labor intensive purification (interpreted as silicone hydride; and metal catalyst, claim 1) (Abstract, line 1-6). Risangud teaches that the PDMS polymer class exhibit excellent material properties including high flexibility, excellent thermo-oxidative stability, high moisture resistance, low glass transition temperature and non-toxicity, which can be used in semiconductor devices (interpreted as for use in sensors, claim 1) (pg. 5879, col 2, first partial paragraph). Risangud teaches using commercially available telechelic PDMS hydrides (h2PDMS) have been modified with a range of different methacrylates using very low catalytic amounts of commercial Pt(II) catalysts, wherein the products have been characterized by MALDI-ToF MS demonstrating high selectivity and very high reaction yields, such that the versatility of hydrosilyation has been exploited for the preparation of ABA triblock copolymers using poly(ethylene glycol) methacrylate and more structurally demanding vinyl terminated methacrylic macromonomers as obtained by catalytic chain transfer polymerization (CCTP); and that 1H NMR revealed the formation of solely anti-Markovnikov products and the high tolerance of the reaction towards other functionalities, such as epoxides present in glycidyl methacrylate, wherein the specific Si-H signals in 1H NMR (4.8 ppm) and IR (2126 cm-1) from the Si–H group allow for facile monitoring of the progress of the reaction (interpreted as silicone hydride; reaction with functional groups such as ethylene oxide, methacrylate, epoxides, etc.; and Pt metal catalyst, claims 2 and 3) (Abstract, lines 6-17). Risangud teaches that hydrosilylation was employed as a versatile and efficient method for the synthesis of functional telechelic PDMS (Scheme 1B); and that PDMS with hydride a,w-end groups (h2PDMS; average Mn 580 g mol-1) was modified with different methacrylates (Scheme 2), including methyl methacrylate (MMA), 2-hydroxylethyl methacrylate (HEMA), glycidyl methacrylate (GMA), lauryl methacrylate (LMA), 2-ethyl hexyl methacrylate (EHMA), butyl methacrylate (BMS) and diethylene glycol methyl ether methacrylate (DEGMEMA) (interpreted as functional groups including methacrylate, hydroxyethyl methacrylate, and glycidyl methacrylate, claims 1-3 and 5) (pg. 5580, col 1, last partial paragraph). Risangud teaches in Scheme 2, hydrosilylation of methacrylate monomer and h2PDMS hydride terminated, wherein R represents a same function as another end (interpreted as structures as recited claim 1; and including the W groups of claim 5, claims 1-3 and 5) (pg. 5580, col 2, Scheme 2). Scheme 2 is shown below:
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wherein Z is O; X is methyl; n>1; and W is O-alkylhydroxy, O-alkylalkoxy, O-methacrylate, and O-acrylate; and including -O-(CH2)mCH3, -O(CH2)2OH,-O-CH2-(CH2)2O, -(O-CH2CH2)m-O-C=O-C(CH2)(CH3) (interpreted as the structures encompassed by claims 1-3 and 5) (pg. 5880, col 2, Scheme 2). Moreover, Risangud teaches in Scheme 3 the synthesis of ABA triblock copolymers using PEGMA and CCT oligomer, as shown below:
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wherein the product has the structure of the membrane of claim 1 (interpreted as the membrane of claim 1, claim 1) (pg. 5582, col 1, Scheme 3). Risangud teaches that hydrosilylation represents a powerful tool for the fabrication of functional PDMS materials, including end-functional PDMS and triblock copolymers (pg. 5583, col 1, last full paragraph, lines 1-3).
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of a reaction for the efficient preparation of organo-silicon compounds as exemplified by Risangud, it would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of preparing analyte sensor membranes comprising a blended mixture of linear polymers and a branched acrylate polymer as disclosed by Wang to include the hydrosilylation reaction for polymer synthesis including modification with functional methacrylates and the production of functional PDMS polymers that can be used in semi-conductor devices as taught by Risangud with a reasonable expectation of success in the efficient production of silicone polymer analyte modulating membranes such as glucose sensors comprising different functionalized methacrylates in very high yield, without the formation of side products, without odor, without the need for labor-intensive purification methods and/or where the progress of the reaction is easily monitored by mass spectrometry; and/or in producing a class of silicone polymer membranes that exhibit excellent material properties including high flexibility, excellent thermo-oxidative stability, high moisture resistance, low glass transition temperature and non-toxicity.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Response to Arguments
Applicant’s remarks filed November 14, 2025 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) as discussed herein, Applicant asserts that Wang does not teach or suggest all features of claim 1; and Risangud does not remedy the above-described shortcoming of Wang, such that Applicant asserts that claim l is not obvious over \Vang in view of Risangud (Applicant Remarks, pg. 19, third through fifth full paragraphs).
Regarding (a), it is noted that none of the references has to teach each and every claim limitation. If they did, this would have been anticipation and not an obviousness-type rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Risangud clearly teaches the structure recited in instant claim 1. Applicant did not distinctly and specifically point out the supposed errors in the Examiner’s action as required by 37 CFR 1.111(b). Thus, the claims remain rejected for the reasons already of record.
Conclusion
Claims 1-3 and 5 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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/AMY M BUNKER/Primary Examiner, Art Unit 1684