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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 16, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Fig. 6 reference numbers 1014, 1014a, 1014b, 1014c, 1013, 1013a, 1013b, 1012a, 1012b, 1012c, 105a, 105b, 105c; and Fig. 9 reference numbers 1014, 1014a, 1014b, 1014c, 1013, 1013a, 1013b, 105a, 105b, 105c. 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.
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.
Claim 15 is 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. Claim 15 are directed to an olfactory test method using an algorithm, which is an abstract idea. Claim 15 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 15 is as follows:
Step 1: Claim 15 is drawn to a process.
Step 2A – Prong One: Claim 15 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “a detection step of detecting an attachment status of a cartridge holding an odor component with respect to a cartridge holding unit”;
[B1] – “a reading step of reading information of the cartridge”; and
[C1] – “a management step of managing a state of the cartridge on a basis of cartridge information acquired in the reading step”.
These elements [A1]-[C1] of claim 15 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 15 recites the following limitations that are beyond the judicial exception:
[A2] – “a cartridge holding an odor component with respect to a cartridge holding unit”
These elements [A2] of claim 15 do not integrate the exception into a practical application of the exception. In particular, the element [A2] merely generally links the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h).
Step 2B: Claim 15 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “an attachment status of a cartridge holding an odor component with respect to a cartridge holding unit” does not qualify as significantly more because this limitation merely describes the nature of the attachment and information being assessed and does not incorporate the cartridge or cartridge holding unit as part of the claimed invention.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160287161 A1 (Smith et al.).
Regarding claim 1, Smith teaches an olfactory test device (Abstract, [0016]) comprising:
a main body ([0054] “a module, generally described as 40 in FIG. 3, designed, constructed and configured for accepting at least one cartridge”); and
a cartridge that holds an odor component ([0040] “a cartridge, generally described as 10 in FIGS. 1 and 2, for providing odorant for testing human olfactory systems”),
wherein the main body includes
a cartridge holding unit that holds the cartridge ([0055] “the olfactometry module includes an adaptor designed, constructed and configured for accepting and activating a puncture-activated, non-resealable cartridge with an odorant”),
a detection unit that detects an attachment status of the cartridge with respect to the cartridge holding unit ([0049] “Verification of the concentration in the headspace or other concentration verification is used to indicate when the cartridge replacement is required (i.e., when the concentration is too low or the cartridge is spent). Preferably, verification of the concentration is performed via a photo ionization detector”; [0055] “a detector for measuring the gas-borne concentration of the odorant in the headspace of the cartridge”; [0061]; [0065] “the detector 72 determines if the required amount of odor is contained in the stimulus air.”; [0069]), and
an output unit that outputs a detection signal of cartridge attachment in the detection unit ([0047] “The information from the identifier is communicated to the device and/or remote server to calibrate testing and standardize, normalize or otherwise correct test data for the particular odorant cartridge's properties.”).
Regarding claim 2, Smith teaches the olfactory test device according to claim 1, wherein the cartridge includes a first identification unit that identifies cartridge information ([0047] “each cartridge also incorporates an identifier 32, such as a digital chip, bar code, etc., within, or about the cover or body to identify the odorant(s) in the cartridge. The identifier is automatically detected and read by a reader 33 and the information used to regulate the air flow and actuation rate of the cartridge.”).
Regarding claim 3, Smith teaches the olfactory test device according to claim 1, wherein the main body includes a second identification unit that identifies main body information ([0048] “a cartridge is automated to present an odor to and obtain information from a person. Following odor presentation, the module or controller receives the user response data. The response data preferably are provided to a mobile computing device that communicates the response data with other system components.”).
Regarding claim 4, Smith teaches the olfactory test device according to claim 1, wherein the cartridge and/or the cartridge holding unit includes a deformation mechanism that deforms when the cartridge is attached ([0041] “The cartridge is preferably activated by puncturing the impermeable cover by piercing with an air inlet tube 22 and an air outlet tube 24 when the cartridge is inserted into an apparatus and activated.”).
Regarding claim 5, Smith teaches an olfactory test system (Abstract) comprising:
an olfactory test device (Abstract, [0016]) including
a main body ([0054] “a module, generally described as 40 in FIG. 3, designed, constructed and configured for accepting at least one cartridge”), and
a cartridge that holds an odor component ([0040] “a cartridge, generally described as 10 in FIGS. 1 and 2, for providing odorant for testing human olfactory systems”),
the main body including
a cartridge holding unit that holds the cartridge ([0055] “the olfactometry module includes an adaptor designed, constructed and configured for accepting and activating a puncture-activated, non-resealable cartridge with an odorant”),
a detection unit that detects an attachment status of the cartridge with respect to the cartridge holding unit ([0049] “Verification of the concentration in the headspace or other concentration verification is used to indicate when the cartridge replacement is required (i.e., when the concentration is too low or the cartridge is spent). Preferably, verification of the concentration is performed via a photo ionization detector”; [0055] “a detector for measuring the gas-borne concentration of the odorant in the headspace of the cartridge”; [0061]; [0065] “the detector 72 determines if the required amount of odor is contained in the stimulus air.”; [0069]), and
an output unit that outputs a detection signal of attachment in the detection unit ([0047] “The information from the identifier is communicated to the device and/or remote server to calibrate testing and standardize, normalize or otherwise correct test data for the particular odorant cartridge's properties.”); and
an information processing device including a processing unit that manages a state of the cartridge on a basis of the detection signal output from the output unit ([0040] “The cartridge houses, contains, or holds an odorant 12 for testing, and is connectable, by wire or wirelessly, to a computing device, which maintains control and command of the cartridge and receives input of testing results”; [0090] “The server 850 includes a processing unit 851 with an operating system 852.”; [0090-0102]).
Regarding claim 6, Smith teaches the olfactory test system according to claim 5,
wherein the cartridge includes a first identification unit that identifies cartridge
information ([0047] “each cartridge also incorporates an identifier 32, such as a digital chip, bar code, etc., within, or about the cover or body to identify the odorant(s) in the cartridge.”), and
the olfactory test system further comprises a reading unit that reads the cartridge information from the first identification unit ([0047] “The identifier is automatically detected and read by a reader 33”).
Regarding claim 7, Smith teaches the olfactory test system according to claim 6, wherein the processing unit manages the state of the cartridge on a basis of the cartridge information acquired by the reading unit ([0040] “The cartridge houses, contains, or holds an odorant 12 for testing, and is connectable, by wire or wirelessly, to a computing device, which maintains control and command of the cartridge and receives input of testing results”; [0055-0056]).
Regarding claim 8, Smith teaches the olfactory test system according to claim 7, wherein the state of the cartridge is one or more states selected from an attachment status, a number of times of use, and a period of use of the cartridge ([0049] “Verification of the concentration in the headspace or other concentration verification is used to indicate when the cartridge replacement is required (i.e., when the concentration is too low or the cartridge is spent). Preferably, verification of the concentration is performed via a photo ionization detector. The testing device controls and varies the delivered test air volume and test frequency. The delivered test air volume will vary based on the desired concentration to deliver to the subject and from presentation to presentation for the subject. The test frequency or trial rate (number of tests per time period) will vary based on the previous test air volume delivered, wherein the limiting factor for test frequency is the time required to saturate the headspace or otherwise ensure that the cartridge headspace has the proper odor vapor concentration, which is dictated by odorant(s) volatility and airflow.”).
Regarding claim 9, Smith teaches the olfactory test system according to claim 7, further comprising a display unit that displays an alert in a case where the state of the cartridge exceeds a specific threshold value ([0049] “Verification of the concentration in the headspace or other concentration verification is used to indicate when the cartridge replacement is required (i.e., when the concentration is too low or the cartridge is spent)”; [0050] “At the initial activation of a cartridge, the odor concentration is determined and the appropriate amount of airflow is calculated to provide adequate odor concentration for all programmed tests, e.g., for a given test session or patient or until the concentration is too low to continue (and then a new cartridge is used to replace the spent cartridge).”; [0069] “The apparatus includes detectors that can measure vapor concentration through such mechanisms as photoionization, thermal conductivity, charge detection, infrared absorption, etc. The apparatus then correspondingly alters the ratio of carrier air mixed with the cartridge effluent air, postpones a test, or alerts a test administrator so that only proper tests are performed.”; [0093] “display units”).
Regarding claim 10, Smith teaches the olfactory test system according to claim 6,
wherein the main body includes a second identification unit that identifies main body information ([0048] “cartridge is automated to present an odor to and obtain information from a person. Following odor presentation, the module or controller receives the user response data”), and
the reading unit reads the main body information from the second identification unit ([0048] “The response data preferably are provided to a mobile computing device that communicates the response data with other system components.”).
Regarding claim 11, Smith teaches the olfactory test system according to claim 10, wherein the information processing device includes a control unit that controls removal of the cartridge ([0050] “At the initial activation of a cartridge, the odor concentration is determined and the appropriate amount of airflow is calculated to provide adequate odor concentration for all programmed tests, e.g., for a given test session or patient or until the concentration is too low to continue (and then a new cartridge is used to replace the spent cartridge)”).
Regarding claim 14, Smith teaches the olfactory test system according to claim 11, wherein the control unit controls removal of the cartridge on a basis of reading information acquired by the reading unit ([0049] “Verification of the concentration in the headspace or other concentration verification is used to indicate when the cartridge replacement is required (i.e., when the concentration is too low or the cartridge is spent). Preferably, verification of the concentration is performed via a photo ionization detector. The testing device controls and varies the delivered test air volume and test frequency.”; [0050]).
Regarding claim 15, Smith teaches an olfactory test method comprising:
a detection step of detecting an attachment status of a cartridge holding an odor component with respect to a cartridge holding unit ([0041]; [0049] “Verification of the concentration in the headspace or other concentration verification is used to indicate when the cartridge replacement is required (i.e., when the concentration is too low or the cartridge is spent). Preferably, verification of the concentration is performed via a photo ionization detector”; [0055] “a detector for measuring the gas-borne concentration of the odorant in the headspace of the cartridge”; [0061]; [0065] “the detector 72 determines if the required amount of odor is contained in the stimulus air.”; [0069]);
a reading step of reading information of the cartridge ([0047] “each cartridge also incorporates an identifier 32, such as a digital chip, bar code, etc., within, or about the cover or body to identify the odorant(s) in the cartridge. The identifier is automatically detected and read by a reader 33 and the information used to regulate the air flow and actuation rate of the cartridge”); and
a management step of managing a state of the cartridge on a basis of cartridge information acquired in the reading step ([0047] “The information from the identifier is communicated to the device and/or remote server to calibrate testing and standardize, normalize or otherwise correct test data for the particular odorant cartridge's properties.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160287161 A1 (Smith et al.) in view of US 20140170020 A1 (Hiruta, Atsushi).
Regarding claim 12, Smith teaches the olfactory test system according to claim 11.
Smith does not explicitly teach wherein the cartridge and/or the cartridge holding unit includes a cartridge removal locking mechanism, and the cartridge removal locking mechanism sets or releases a cartridge removal lock on a basis of a control command from the control unit.
However,
Hiruta teaches wherein the cartridge and/or the cartridge holding unit includes a cartridge removal locking mechanism ([0053] “The lock operation control unit 202 is a unit that performs locking and unlocking operations of the cartridge attachment door 101.”), and
the cartridge removal locking mechanism sets or releases a cartridge removal lock on a basis of a control command from the control unit ([0053] “The lock operation control unit 202 prevents the cartridge attachment door 101 from being opened by locking the cartridge attachment door 101 and allows the cartridge attachment door 101 to be opened by unlocking the cartridge attachment door 101.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Smith to include a cartridge removal locking mechanism. One would have been motivated to make this modification because the locking mechanism is performed so that the cartridge cannot be taken out so that data can be read successfully, as suggested by Hiruta [0105].
Regarding claim 13, Smith teaches the olfactory test system according to claim 12.
Smith does not explicitly teach wherein in the setting of the cartridge removal lock by the cartridge removal locking mechanism, the lock setting is maintained even when power supply of the olfactory test device is turned off.
However,
Hiruta teaches wherein in the setting of the cartridge removal lock by the cartridge removal locking mechanism, the lock setting is maintained even when power supply of the olfactory test device is turned off ([0359] “in a case where the user turns off the main power, for example, during evaporation and degradation processing of the excessive hydrogen peroxide solution in the cartridge 205 set in the sterilization apparatus 100, operations of the air feeding pressure pump 209 stop. Thus, the hydrogen peroxide steam gasified in the air exhaust evaporation furnace 224 will accumulate in the duct between the air exhaust evaporation furnace 224 and the air exhaust HEPA filter 221, in the air exhaust HEPA filter 221, and in the duct between the air exhaust HEPA filter 221 and the sterilant degradation device 222 since air flow stops”; [0053])
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Smith to include a cartridge removal locking mechanism in lock setting while power is off. One would have been motivated to make this modification because the locking mechanism is performed so that the cartridge cannot be taken out, and the cartridge remains connected to the device even when powered off using components to extend product life by preventing degradation of the contents of the cartridge when powered off, as suggested by Hiruta [0359-0363].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EVELYN GRACE PARK whose telephone number is (571)272-0651. The examiner can normally be reached Monday - Friday, 9AM - 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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