DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted July 7, 2025.
The present application is the national stage entry of International Patent Application
No. PCT/EP2022/050372 filed on January 11, 2022, and claims priority to Application
No. EP 21151287.6, filed on January 13, 2021. Claims 1 – 5, 7 – 9, and 11 – 15 are amended. Claim 10 is cancelled (Claim 6 was previously cancelled). Claim 16 is new. Claims 1 – 5, 7 – 9, and 11 – 16 are presented for examination.
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 .
Drawings
The objection to the drawings are withdrawn based upon the amendment submitted July 7, 2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 5, 7 – 9, and 11 – 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 1 – 5, 7 – 9, and 11 – 16 are drawn to a method, non-transitory computer-readable medium, an apparatus, and a system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites receiving first data indicative of a concentration of a first substance in sweat secreted from sweat glands of a subject; obtaining physiological data relating to the subject, wherein the physiological data relates to a metabolic rate of the first substance in the subject; determining the metabolic rate of the first substance in the subject; and determining a time window regarding the intake of a second substance by the subject, based on the received first data, the determined metabolic rate, and a relationship between a time of occurrence of a characteristic event in relation to the concentration of the first substance in sweat, and a time of occurrence of the characteristic event in relation to the concentration of the first substance in blood.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover Mental Processes, as reflected in the specification, which states that the “invention relates to determining a time window regarding the intake of a substance by a subject and, more particularly, to determining such a time window based on data acquired in respect of sweat of the subject” (paragraph 1 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers concepts performed in the human mind, including an observation, evaluation, judgment, or opinion, then it falls within the “Mental Processes” grouping of abstract ideas. The present claims cover Mental Processes because they address “determining an appropriate time window regarding the intake of a substance by a subject based on measurements acquired in respect of the subject's sweat” (paragraph 5 of the published specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “processor”, “sensor”, “pharmacological model”
Claim 4: “signal”
Claim 5: “control signal”
Claim 7: “pharmacological model”
Claim 8: “sensor”
Claim 12: “non-transitory computer-readable medium that stores therein a computer program product which, when executed on a suitable computer or processor, causes the method of claim 1 to be performed”
Claim 13: “apparatus”, “processor”
Claim 14: “system”, “sweat sensor”, “apparatus”
Claim 15: “system”, “user interface”
Claim 16: “system”, “sweat sensor”, “database”, “pharmacological model”, “processor” , “user interface”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0119] Similarly, the processor 1202 may form part of an apparatus, such as a computing device ( e.g. a desktop computer, a laptop computer, a tablet computer, a smart phone, or a wearable device) or a server. Thus, a further aspect of the present invention provides an apparatus. FIG. 13 is a schematic illustration of an example of an apparatus 1300. The apparatus 1300 comprises a processor 1202 configured to perform steps of the methods 400, 800 disclosed herein. In some embodiments, the apparatus 1300 may further comprise the computer-readable medium 1204.
[0123] The processor 1202 can comprise one or more processors, processing units, multi-core processors or modules that are configured or programmed to control the apparatus 1300 in the manner described herein. In particular implementations, the processor 1202 can comprise a plurality of software and/or hardware modules that are each configured to perform, or are for performing, individual or multiple steps of the method described herein.
[0124] The term "module", as used herein is intended to include a hardware component, such as a processor or a component of a processor configured to perform a particular function, or a software component, such as a set of instruction data that has a particular function when executed by a processor.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 5, 7 – 9, and 11 – 15 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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.
Claim(s) 1 – 4, 7 – 10, and 12 – 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (U.S. Patent Number 11,129,554 B2) in view of De Giovanni et al., herein after De Giovanni (De Giovanni N, Fucci N. The current status of sweat testing for drugs of abuse: a review. Curr Med Chem. 2013;20(4):545-61. doi: 10.2174/0929867311320040006. PMID: 23244520).
Claim 1 (Currently Amended): Heikenfeld teaches a method comprising using a processor for:
receiving, from a sensor, first data indicative of a concentration of a first substance in sweat secreted from sweat glands of a subject (Figure 1; column 3, lines 4 – 6 discloses “sweat sensor data” means all of the information collected by sweat sensor(s) and communications via the device to a user or a data aggregation location);
obtaining physiological data relating to the subject (column 4, lines 57 – 63 disclose physiological data captured by the patient’s wearable device, including, but not limited to pulse, respiration, and heart rate), wherein the physiological data relates to a metabolic rate of the first substance in the subject (column 12, lines 26 – 39 discloses a co-administration of a tracer compound necessitates that this tracer compound also be FDA approved, generally regarded as safe ("GRAS"), or monographed (e.g., aspirin), and accurate knowledge of the tracer compound's pharmacokinetic profile will allow it to be correlated with appropriate drugs of interest which involves matching the two substances' metabolic pathway and/or the time profile between delivery and excretion); and
determining, using a pharmacological model relating to the first substance and the obtained physiological data relating to the subject, the metabolic rate of the first substance in the subject (column 6, lines 18 – 30 discloses a computing and data storage mechanism capable of operating the sweat sensing and drug delivery system, where the computing and data storage mechanism may conduct communication among system components, to monitor sweat sensor data, to perform data aggregation, to execute algorithms capable of controlling drug delivery timing and amounts, and to issue alerts and advisories related to detected analyte levels in sweat; column 6, lines 42 – 56 discloses the emergence of drugs and their metabolites in sweat may vary by individual depending on variances in how the person absorbs, distributes, metabolizes, and excretes the drug).
Heikenfeld fails to explicitly teach the following limitations met by De Giovanni as cited:
determining a time window regarding the intake of a second substance by the subject, based on: (1) the received first data (page 556, column 1, paragraph 5 discloses after opiate administration, patch performances were evaluated and heroin was always present in lower concentrations than 6-acetylmorphine indicating received data), (2) the determined metabolic rate (page 550, column 2, paragraph 1 discloses the rate at which drugs move drugs move from sweat gland to skin surface, indicating a clearance time; page 556, column 1, paragraph 5 discloses after opiate administration, patch performances were evaluated and heroin was always present in lower concentrations than 6-acetylmorphine (which was the major analyte found in sweat) as contrasted to the metabolite profile in blood and urine, indicating a comparison between sweat and blood concentrations) and (3) a relationship between: (a) a time of occurrence of a characteristic event in relation to the concentration of the first substance in sweat, and (b) a time of occurrence of the characteristic event in relation to the concentration of the first substance in blood (page 551, column 1, paragraph 2 discloses the time interval between drug consumption and detection on the skin surface depends on the nature of the particular drug and on the sensitivity of the analytical method used. In chronic abusers drug molecules are permanently present on the skin due to temporary reservoir of the stratum corneum; page 551, column 2, paragraph 5 discloses a sweat patch offers a longer and prospective surveillance period as compared to blood and urine testing).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Heikenfeld to further include sweat testing for drugs of abuse as disclosed by De Giovanni.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Heikenfeld in this way to provide a convenient alternative that avoids some of the problems with drug testing such as violations of privacy in observed urination, possibility of disease transmission, and the transport of noxious fluids, leading to a benefit of low invasiveness and fewer ethical problems for sample collection than blood or urine testing (De Giovanni: page 559, column 2, paragraph 2).
Claim 2 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1. Heikenfeld teaches a method further comprising: determining, based on the relationship and the received first data, a concentration of the first substance in blood of the subject (column 3, lines 12 – 18 discloses a tracer compound having a known co-relationship between the tracer compound’s concentration with the concentration of a primary drug in blood or an organ; column 9, lines 16 – 20 discloses sensing and delivery system to detect and monitor a drug in sweat and utilize that to determine relevant information about the concentration of that drug in blood, plasma, or an organ).
Claim 3 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1. Heikenfeld teaches a method further comprising:
receiving, prior to receiving the first data, second data indicative of the time of occurrence of the characteristic event in relation to the concentration of the first substance in blood (column 3, lines 59 – 67 discloses “The ability to detect the concentration of a drug in sweat over time requires the use of a chronologically assured sweat sampling rate. To understand the proper numerical values or representations of sweat sampling rate, sweat generation rate and sweat volumes should be understood. Based on the assumption of a sweat gland density of 100/cm2, a sensor that is 0.55 cm in radius (1.1 cm in diameter) would cover about 1 cm2 area or approximately 100 sweat glands. Next, assume a sweat volume under a skin-facing sensor (space between the sensor and the skin) of 50 μm average height or 50x10-4 cm, and that same 1 cm2 area, which provides a sweat volume of 50x10-4 cm3 or about 50x10-4 mL or 5 μL of volume. With the maximum sweat generation rate of 5 nL/min/gland and 100 glands, it would require a 10 minutes to fully refresh the sweat volume (using 1st principles/simplest calculation only). With the minimum sweat generation rate of 0.1 nL/min/gland and 100 glands, it would require 500 minutes or 8 hours to fully refresh the sweat volume.”; column 4, lines 39 – 40 discloses sweat generation can be measured in real time; column 6, lines 63 – 66 discloses the sweat sensor data monitored by the user may include real-time data, trend data, or may also include aggregated sweat sensor data drawn from the system database).
Claim 4 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1. Heikenfeld teaches a method further comprising: generating a signal to alert a user about the determined time window (column 6, lines 18 – 30 discloses executing algorithms capable of controlling drug delivery timing and to issue alerts and advisories related to detected analyte levels in sweat).
Claim 7 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1. Heikenfeld teaches a method further comprising: obtaining at least one of a first pharmacological model relating to the first substance and a second pharmacological model relating to the second substance (column 6, lines 18 – 30 discloses a computing and data storage mechanism capable of operating the sweat sensing and drug delivery system, where the computing and data storage mechanism may conduct communication among system components, to monitor sweat sensor data, to perform data aggregation, to execute algorithms capable of controlling drug delivery timing and amounts, and to issue alerts and advisories related to detected analyte levels in sweat; column 11, lines 9 – 12 disclose drug and tracer and/or their metabolites (DM and TM) could be measured to increase the value of data measurements obtained by the sweat sensor).
Heikenfeld fails to explicitly teach the following limitations met by De Giovanni as cited:
wherein determining the time window is further based on at least one of the first pharmacological model and the second pharmacological model (page 551, column 1, paragraph 2 discloses the time interval between drug consumption and detection on the skin surface depends on the nature of the particular drug and on the sensitivity of the analytical method used. In chronic abusers drug molecules are permanently present on the skin due to temporary reservoir of the stratum corneum; page 551, column 2, paragraph 5 discloses a sweat patch offers a longer and prospective surveillance period as compared to blood and urine testing; page 556, column 1, paragraph 5 discloses after opiate administration, patch performances were evaluated and heroin was always present in lower concentrations than 6-acetylmorphine (which was the major analyte found in sweat) as contrasted to the metabolite profile in blood and urine, indicating a comparison between sweat and blood concentrations).
The motivation to combine the teachings of Heikenfeld and De Giovanni is discussed in the rejection of claim 1, and incorporated herein.
Claim 8 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1.
Heikenfeld fails to explicitly teach the following limitations met by De Giovanni as cited:
wherein the determining the relationship is based on at least one of:
a determination of the time taken for the first substance to be detected in blood of the subject following intake of the first substance by the subject (page 551, column 1, paragraph 2 discloses the time interval between drug consumption and detection on the skin surface depends on the nature of the particular drug and on the sensitivity of the analytical method used. In chronic abusers drug molecules are permanently present on the skin due to temporary reservoir of the stratum corneum; page 551, column 2, paragraph 5 discloses a sweat patch offers a longer and prospective surveillance period as compared to blood and urine testing; page 556, column 1, paragraph 5 discloses after opiate administration, patch performances were evaluated and heroin was always present in lower concentrations than 6-acetylmorphine (which was the major analyte found in sweat) as contrasted to the metabolite profile in blood and urine, indicating a comparison between sweat and blood concentrations);
an estimate of the time taken for the first substance to be detected in blood of the subject following intake of the first substance the subject, the estimate based on a population of people;
an indication of the time taken for an effect of the first substance to be detected by a user following intake of the first substance by the subject; or
an indication of the time taken for an effect of the first substance to be detected by a sensor following intake of the first substance by the subject.
The motivation to combine the teachings of Heikenfeld and De Giovanni is discussed in the rejection of claim 1, and incorporated herein.
Claim 9 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1. Heikenfeld teaches a method wherein the received first data comprises data indicative of a concentration of a metabolite of the first substance in the secreted sweat from sweat glands of a subject over a period of time (column 6, lines 18 – 30 discloses a computing and data storage mechanism capable of operating the sweat sensing and drug delivery system, where the computing and data storage mechanism may conduct communication among system components, to monitor sweat sensor data, to perform data aggregation, to execute algorithms capable of controlling drug delivery timing and amounts, and to issue alerts and advisories related to detected analyte levels in sweat; column 11, lines 9 – 12 disclose drug and tracer and/or their metabolites (DM and TM) could be measured to increase the value of data measurements obtained by the sweat sensor).
Heikenfeld fails to explicitly teach the following limitations met by De Giovanni as cited:
wherein the determining the relationship comprises determining a relationship between the time of occurrence of a characteristic event in relation to the concentration of the metabolite of the first substance in sweat and the time of occurrence of the characteristic event in relation to the concentration of the metabolite of the first substance in blood (page 551, column 1, paragraph 2 discloses the time interval between drug consumption and detection on the skin surface depends on the nature of the particular drug and on the sensitivity of the analytical method used. In chronic abusers drug molecules are permanently present on the skin due to temporary reservoir of the stratum corneum; page 551, column 2, paragraph 5 discloses a sweat patch offers a longer and prospective surveillance period as compared to blood and urine testing; page 556, column 1, paragraph 5 discloses after opiate administration, patch performances were evaluated and heroin was always present in lower concentrations than 6-acetylmorphine (which was the major analyte found in sweat) as contrasted to the metabolite profile in blood and urine, indicating a comparison between sweat and blood concentrations).
The motivation to combine the teachings of Heikenfeld and De Giovanni is discussed in the rejection of claim 1, and incorporated herein.
System and apparatus claims 12 – 16 repeat the subject matter of claim 1. As the underlying processes of claims 12 – 16 have been shown to be fully disclosed by the teachings of Heikenfeld and De Giovanni in the above rejections of claim 1; as such, these limitations (12 – 16) are rejected for the same reasons given above for claim 1, and incorporated herein.
Claim(s) 5 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld (U.S. Patent Number 11,129,554 B2) in view of De Giovanni et al., herein after De Giovanni (De Giovanni N, Fucci N. The current status of sweat testing for drugs of abuse: a review. Curr Med Chem. 2013;20(4):545-61. doi: 10.2174/0929867311320040006. PMID: 23244520) further in view of Melker et al., herein after Melker (U.S. Publication Number 2013/0296823).
Claim 5 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim 1.
Heikenfeld and De Giovanni fail to explicitly teach the following limitations met by Melker as cited:
further comprising: generating a control signal to control delivery of the second substance at a time based on the determined time window (paragraph 44 discloses based on instantaneous or substantially instantaneous and/or trending of relevant PD (pharmacodynamic) and/or PK (pharmacokinetic) parameters, and based on appropriate algorithms (appropriate to a give subject, to a given subject type, to a given condition, to a given condition type), a control system is able to receive the PD and/or PK signals throughout an infusion or similar treatment process and to either increase, decrease or maintain the rate of infusion of one or more drugs and/or fluids to the subject).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Heikenfeld and De Giovanni to further include a pharmacodynamic (PD), pharmacokinetic (PK), or both PD and PK guided infusion device, system, and method that optimizes the safety and efficacy of various forms of treatment or therapy in a variety of healthcare and other setting as disclosed by Melker.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Heikenfeld and De Giovanni in this way to safely deliver opioids and other drugs to hospice or other patients with chronic pain, or in environments where the effective management of acute pain with narcotics is required so the danger of over-medication is reduced or eliminated (Melker: paragraph 14).
Claim 11 (Currently Amended). Heikenfeld and De Giovanni teach the method according to claim1.
Heikenfeld and De Giovanni fail to explicitly teach the following limitations met by Melker as cited:
wherein the first substance and the second substance interact with one another; or wherein a metabolic product of the first substance and the second substance interact with one another (paragraph 95 discloses opioids frequently cause mortality because it suffers from a major pharmacodynamic interaction with ethanol (drug-drug interaction).
The motivation to combine the teachings of Heikenfeld, De Giovanni, and Melker is discussed in the rejection of claim 5, and incorporated herein.
Response to Arguments
Applicant's arguments filed July 7, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections - 35 USC § 101
The Applicant argues the present claims are not directed to the abstract idea of a Mental Process. The Examiner respectfully disagrees. The Examiner respectfully submits that the PEG (Patent Eligibility Guidelines) of January 2019 recite that the test is not that they ARE performed in the mind, but that they CAN be practically performed in the mind or even with a pen and paper. Claim 1 of the present claims recite receiving first data indicative of a concentration of a first substance in sweat secreted from sweat glands of a subject; obtaining physiological data relating to the subject, wherein the physiological data relates to a metabolic rate of the first substance in the subject; determining the metabolic rate of the first substance in the subject; and determining a time window regarding the intake of a second substance by the subject, based on the received first data, the determined metabolic rate, and a relationship between a time of occurrence of a characteristic event in relation to the concentration of the first substance in sweat, and a time of occurrence of the characteristic event in relation to the concentration of the first substance in blood.
The claims are abstract but for the inclusion of the additional elements including a such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f). The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components.
Thus, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind.
Claim Rejections - 35 USC § 103
The Applicant argues Heikenfeld, taken alone or together with De Giovanni and Melke) fails to disclose or suggest “determining, using a pharmacological model relating to the first substance and the obtained physiological data relating to the subject, the metabolic rate of the first substance in the subject”. The Examiner respectfully disagrees. Heikenfeld defines a "drug response profile" as the collection of sweat sensor data on sweat rate, temperature, pH, and/or analytes that indicate the chronological concentration and ratios of those analytes in the blood stream of a target individual that is correlated to the presence of a primary drug (column 3, lines 30 – 35), and a “drug detection threshold" is defined as a calculated detection level in sweat of a primary drug, tracer(s), metabolite(s), other analyte(s), or a combination of these analytes that shows the primary drug is present in the blood or an organ with reasonable certainty (column 3, lines 40 – 44). A computing and data storage mechanism capable of operating the sweat sensing and drug delivery system, where the computing and data storage mechanism may conduct communication among system components, to monitor sweat sensor data, to perform data aggregation, to execute algorithms capable of controlling drug delivery timing and amounts, and to issue alerts and advisories related to detected analyte levels in sweat (column 6, lines 18 – 30) and the emergence of drugs and their metabolites in sweat may vary by individual depending on variances in how the person absorbs, distributes, metabolizes, and excretes the drug (column 6, lines 42 – 56), indicating a rate the drug of interest is metabolized by an individual person. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682