Prosecution Insights
Last updated: April 17, 2026
Application No. 18/244,906

Non Invasive Device for Early Stage Alzheimer's and Neurodegenerative Disease Detection

Non-Final OA §101§103§112
Filed
Sep 11, 2023
Examiner
KIM, SAMUEL CHONG
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
unknown
OA Round
1 (Non-Final)
48%
Grant Probability
Moderate
1-2
OA Rounds
4y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allow Rate
107 granted / 221 resolved
-21.6% vs TC avg
Strong +72% interview lift
Without
With
+71.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
43 currently pending
Career history
264
Total Applications
across all art units

Statute-Specific Performance

§101
11.1%
-28.9% vs TC avg
§103
39.7%
-0.3% vs TC avg
§102
7.7%
-32.3% vs TC avg
§112
36.5%
-3.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 221 resolved cases

Office Action

§101 §103 §112
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. Claim Objections Claims 2- 4, 6-10, 12-20 are objected to because of the following informalities: Claim 2, lines 1-2: “a signature or profile” should be replaced with –the profile or signature–; Claim 3, 4, 6-10, 12-20: a comma should be added after each recitation of “The sniffer device of claim [number]” (f or example, claim 3 should be amended to recite “The sniffer device of claim 2 , further comprising” ); Claim 9, line 1: –further– should be inserted before “comprising” ; and Claim 17, line 17: –wherein–should be inserted before “said”. Appropriate correction is required. Applicant is advised that should claim 12 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. No limitations were interpreted under 35 U.S.C. §112(f). Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 18 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 18 recites “wherein said headgear is in…” in line 1. There is insufficient antecedent basis for “said headgear” in the claim because the claim does not previously recite headgear. Additionally, it is unclear how “ wherein said headgear” further limits the claimed invention because it does not refer to any previously-recited claim elements. The Examiner suggests amending the recitation to be “further comprising headgear in…” Claim 19 recites “wherein said collector module comprises…” in line 1. There is insufficient antecedent basis for “said collector module” in the claim because the claim does not previously recite a collector module. Additionally, it is unclear how “ wherein said collector module” further limits the claimed invention because it does not refer to any previously-recited claim elements. The Examiner suggests amending the recitation to be “further comprising a collector module comprising…” 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. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim 9 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 9 recites “a sensing surface external to the otic meatus” in line 1. The recitation requires the sensing surface to be placed relative to the otic meatus, which requires the human organism. Therefore, the claim 9 encompasses a human organism. The Examiner suggests amending the claim to recite “a sensing surface configured to be external to the otic meatus”. 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. Claims 1 , 2, 5, and 9- 11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ). With regards to claim 1, Fink teaches a sniffer device for disease detection, said device (Fig . 3 and p age 8, lines 5-22 depict a block diagram of an electronic odor sensor of F igs. 1-2 and 9-12; p age 6, lines 15-24 depict the device may be used for detecting a small subset of odors that may be important to one or more disease states, and t he odor signature or changes in the odor signature may be part of a medical diagnosis, or may be used as an indicator of change in the health state ) comprising: a portal, sized to enter the ear canal and configured to collect gas therefrom ( Fig. 3 and page 8, lines 5-53 depict input gas 300 comes into the electronic odor sensor 301 through a port; F ig. 12 and page 5, lines 26-32 depict a tube 82 for collecting gas from within the ear canal, wherein the entrance to the tube 82 corresponds to the claimed portal; also see page 5, lines 4-14) ; a passage connecting said portal to an array of elements sensitive to at least one volatile organic compound (VOC) flowing through said passage to become available to said array (Fig. 3 depicts a passage between the gas input 300 to a gas chromatograph (“GC”) 304 coupled with a differential ion mobility spectrometer (“DMS) 305 ; page 1 2 , line 3 to page 13, line 6 teach alternative odor sensor embodiments comprising arrays of sensitive elements) ; said array configured to produce data output in response to interaction with said at least one VOC (Fig. 12 depict s a data analysis tool 86 for receiving and analyzing data from electronic odor sensor 81) ; a processor receiving said data output (Fig. 12 depicts a data analysis tool 86 for receiving and analyzing data from electronic odor sensor 81) , said processor processing said data output to form a profile or signature characterizing the VOC content within said ear canal (Page 6, lines 15-24 depict the result of the gas analysis may be a survey of the odors present in the ear and their relative or absolute concentrations (odor signatur e) ) ; and an interface capable of outputting said signature or profile for further analysis (Page 6, lines 15-24 depict the result of the gas analysis may be presented to the patient or person whose ear odor is being sampled, or it may be communicated to a central facility that is remote from the patient, or to a clinic or doctor who may wish to monitor the person or patient; Page 6, line 25 to page 7, line 11 depict medical information output may be communicated through wired and/or wireless processes) . Fink is silent regarding whether the sniffer device is for early stage autoimmune and/or neurodegenerative disease detection and an array of nanosensing elements sensitive to at least one volatile organic compound (VOC). In the same field of endeavor of sniffer devices, Finberg teaches detect ing early stage autoimmune and/or neurodegenerative disease using a volatile organic compound signature ( Page 2551: left column: first full paragraph teaches detecting altered breath VOC composition characteristic of Parkinson’s disease in de novo PD patients. Page 2549: left column: first full paragraph indicates that de novo PD corresponds to Parkinsonian patients at first diagnosis, before onset of therapy, which is an early stage) , wherein the volatile organic compound signature is determined using an array of nanosensing elements sensitive to at least one volatile organic compound (VOC) (Page 2551: right column: second full paragraph teaches an array of 40 cross-reactive sensors based on gold nanoparticles (GNPs) or single walled carbon nanotubes (CNTs) functionalized with different organic chemical ligands and determining at least four features of the sensors) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have mo dified the electronic odor sensor of Fink to incorporate that it detects early stage autoimmune and/or neurodegenerative disease as taught by Finberg. The motivation would have been to assist in early neuroprotective therapy resulting in better clinical outcomes (see Finberg: page 2548: left column: first full paragraph) and/or to improve the diagnostic capabilities of the device. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensing array of Fink of th e above combination with an array of nanosensing elements sensitive to at least one volatile organic compound (VOC) as taught by Finberg. Because it both arrays are capable of being used for detecting VOC signatures ( page 12, line 3 to page 13, line 6 of Fink; Sensor Array and GC-MS Determinations of Finberg ) , it would have been the simple substitution of one known equivalent element for another to obtain predictable results. With regards to claim 2, the above combination teaches or suggests a data analyzer capable of receiving a signature or profile developed by the device (Page 6, lines 15-24 of Fink d iscloses results of the gas analysis being sent to a central facility) . With regards to claim 5, the above combination teaches or suggests a heater component (Page 9, lines 6-7 of Fink discloses the trap 303 may be heat ed to release the analytes into the GC column 304, which requires a heater component) . With regards to claim 9, the above combination teaches or suggests a sensing surface external to the otic meatus (Fig. 12 of Fink depicts a surface of the Electronic Odor Sensor 81 being external to the otic meatus) . With regards to claim 10, the above combination teaches or suggests a tube extending from said portal to said array of nanosensing elements (Fig. 12 and page 5, lines 26-32 of Fink depict a tube 82 extending from an entrance at the ear to the electronic odor sensor 81) . With regards to claim 1 1 , Fink teaches a sniffer device for disease detection, said device (Fig. 3 and page 8, lines 5-22 depict a block diagram of an electronic odor sensor of Figs. 1-2 and 9-12; page 6, lines 15-24 depict the device may be used for detecting a small subset of odors that may be important to one or more disease states, and t he odor signature or changes in the odor signature may be part of a medical diagnosis, or may be used as an indicator of change in the health state ) comprising: a shield, sized and shaped to enclose or cover the ear canal and configured to collect gas (Fig. 3 and page 8, lines 5-53 depict input gas 300 comes into the electronic odor sensor 301 through a port; Fig s . 10 -11 and page 5, lines 15- 25 depict a cover of the ear canal and a tube 61 that runs through the cover and into the ear canal ; also see page 5, lines 4-14) ; a passage through said shield to an array of elements sensitive to at least one volatile organic compound (VOC) flowing through said passage to become available to said array ( Fig s . 10 -11 and page 5, lines 15- 25 depict a tube 61 that runs through the cover for gas analysis ; Fig. 3 depicts a passage between the gas input 300 to a gas chromatograph (“GC”) 304 coupled with a differential ion mobility spectrometer (“DMS) 305; page 12, line 3 to page 13, line 6 teach alternative odor sensor embodiments comprising arrays of sensitive elements) ; said array configured to produce data output in response to interaction with said at least one VOC (Fig. 12 depicts a data analysis tool 86 for receiving and analyzing data from electronic odor sensor 81) ; a processor receiving said data output (Fig. 12 depicts a data analysis tool 86 for receiving and analyzing data from electronic odor sensor 81) , said processor processing said data output to form a profile or signature characterizing the VOC content within said ear canal (Page 6, lines 15-24 depict the result of the gas analysis may be a survey of the odors present in the ear and their relative or absolute concentrations (odor signatur e) ) ; and an interface capable of outputting said signature or profile for further analysis (Page 6, lines 15-24 depict the result of the gas analysis may be presented to the patient or person whose ear odor is being sampled, or it may be communicated to a central facility that is remote from the patient, or to a clinic or doctor who may wish to monitor the person or patient; Page 6, line 25 to page 7, line 11 depict medical information output may be communicated through wired and/or wireless processes) . Fink is silent regarding whether the sniffer device is for early stage autoimmune and/or neurodegenerative disease detection and an array of nanosensing elements sensitive to at least one volatile organic compound (VOC). In the same field of endeavor of sniffer devices, Finberg teaches detecting early stage autoimmune and/or neurodegenerative disease using a volatile organic compound signature ( Page 2551: left column: first full paragraph teaches detecting altered breath VOC composition characteristic of Parkinson’s disease in de novo PD patients. Page 2549: left column: first full paragraph indicates that de novo PD corresponds to Parkinsonian patients at first diagnosis, before onset of therapy, which is an early stage), wherein the volatile organic compound signature is determined using an array of nanosensing elements sensitive to at least one volatile organic compound (VOC) (Page 2551: right column: second full paragraph teaches an array of 40 cross-reactive sensors based on gold nanoparticles (GNPs) or single walled carbon nanotubes (CNTs) functionalized with different organic chemical ligands and determining at least four features of the sensors) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have mo dified the electronic odor sensor of Fink to incorporate that it detects early stage autoimmune and/or neurodegenerative disease as taught by Finberg. The motivation would have been to assist in early neuroprotective therapy resulting in better clinical outcomes (see Finberg: page 2548: left column: first full paragraph) and/or to improve the diagnostic capabilities of the device. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensing array of Fink of th e above combination with an array of nanosensing elements sensitive to at least one volatile organic compound (VOC) as taught by Finberg. Because it both arrays are capable of being used for detecting VOC signatures (page 12, line 3 to page 13, line 6 of Fink; Sensor Array and GC-MS Determinations of Finberg ) , it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 2 above, and further in view of US 2018/0303378 A (Bazemore). With regards to claim 3, the above combination is silent regarding an interface with a library of profiles or signatures associated with at least one disease. In a system relevant to the problem of disease diagnosis based on volatile organic compounds, Bazemore teaches an interface with a library of profiles or signatures associated with at least one disease (¶ [0007] depicts a database system comprising a collection of disease states correlated with volatile , semi-volatile, and non-volatile emissions; ¶¶ [0008], [0011], [0011] depicts the compound spectra and disease signatures; ¶ [0014] discloses multiple disease indications) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate an interface with a library of profiles or signatures associated with at least one disease as taught by Bazemore. The motivation would have been to identify disease indications as early as possible and/or to make increasingly accurate predictions, at ever earlier stages, for a growing number of diseases (¶ [0007] of Bazemore). With regards to claim 4, the above combination said library comprises profiles or signatures of a plurality of diseases (¶¶ [0007], [0014] of Bazemore depict a plurality of diseases correlated to the VOC emissions) . Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 5 above, and further in view of US 2012/0322682 A1 (Mcdevitt) With regards to claim 6, the above combination is silent regarding whether said heater component operates using radiant heat. In a system relevant to the problem of heating analyte s , Mcdevitt teaches a heater component which operates using radiant heat ( ¶ [0039] teaches a housing which contains heating and cooling means, such as a piezoelectric heater/cooler, radiant heater and fan, peltier, and the like) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the heater component of the above combination with a radiant heater as taught by Mcdevitt because it would have been the simple substitution of one known equivalent heater for another to obtain predictable results. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 5 above, and further in view of US 11,721,533 B1 (Verbeck). With regards to claim 7, the above combination is silent regarding whether said heater component operates using a laser heating element. In a system relevant to the problem of heating analytes, Verbeck teaches a heating mechanism being a laser (Col. 7, lines 22-35 depict a laser heating element). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the heater component of the above combination with a laser heating element as taught by Verbeck because it would have been the simple substitution of one known equivalent heater for another to obtain predictable results. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 5 above, and further in view of US 2020/0187828 A1 (Wheeler). With regards to claim 8 , the above combination is silent regarding whether said heater component operates using a resistive heating element. In a system relevant to the problem of heating analytes, Wheeler teaches a heating mechanism being a laser (¶ [0208] depicts a breath cartridge valve is headed by applying current to power resistor). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the heater component of the above combination with a resistive heating element as taught by Wheeler because it would have been the simple substitution of one known equivalent heater for another to obtain predictable results. Claim s 12-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 11 above, and further in view of US 10,463,275 B2 (King-Smith). With regards to claim 12, t he above combination is silent regarding a cartridge comprising a VOC adsorbent. In the same field of endeavor of VOC analysis, King-Smith teaches a cartridge comprising a VOC adsorbent (Fig. 1 and Col. 6, lines 18- 28, 40-51 depict a liquid collector 710 comprising VOC trapping elements including activated carbon, ceramic, metal organic frameworks (MOFs), plastic polymers, silica, solvents, zeolites, and combinations thereof , which are materials for adsorbing VOCs) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate a cartridge comprising a VOC adsorbent as taught by King-Smith. The motivation would have been to allow for the sample to be sent to a laboratory for additional analysis (Col. 6, lines 21-23 of King-Smith). With regards to claim 13, the above combination teaches or suggests said cartridge is removable (Col. 6, lines 21-23 of King-Smith discloses the collector is replaceable ) . With regards to claims 14 and 20, the above combination teaches or suggests said VOC adsorbent comprises a compound or composition selected from the group consisting of: cotton, aliphatic methacrylates, carbon, PVDF, zeolites, microporous silica, aromatic polydivinylbenzenes polystyrenic-polydivinyl- benzene matrices, and highly cross-linked styrenic polymers (Fig. 1 and Col. 6, lines 18-28, 40-51 of King- Smith depict a liquid collector 710 comprising VOC trapping elements includin g activated carbon) . Claim s 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 11 above, and further in view of US 2023/0157573 A1 (Chen) . With regards to claim 15, the above combination is silent with regards to a deformable membrane. However, Fink teaches a pump to help move the odors from the ear to the electronic odor sensor (Page 6, lines 26- 29 of Fink). In a system relevant to the problem of analyzing volatile organic compounds, Chen teaches a deformable membrane (¶ [0016] discloses a diaphragm pump for driving a sample , which necessarily includes a deformable membrane ) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pump of Fink of the above combination with the diaphragm pump as taught by Chen. Because both pumps are capable of driving samples, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. With regards to claim 16, the above combination teaches or suggests said deformable membrane functions as a pulsatile gas driver (¶ [0016] of Chen discloses a diaphragm pump , which is a pulsatile gas driver) . Claim s 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) , as applied to claim 11 above, and further in view of US 2015/0320591 A1 (Smith). With regards to claim 17, t he above combination is silent regarding whether said shield comprises a heated enclosing portion. In a system relevant to the problem of heating elements , Smith teaches a shield comprising a heated enclosing portion (¶ [0067] an earpiece including a heat exchange block 215 having a passageway 218C ) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shield of the above combination to incorporate a heated enclosing portion as taught by Smith. The motivation would have been to improve the collection of the gases from the air. With regards to claim 18 , the above combination is silent regarding whether headgear is in a form selected from the group consisting of: a headset, form fitting cap, and earmuffs. In a system relevant to the problem of applying elements to an ear, Smith teaches a cover or shield attached to headgear in a form selected from the group consisting of: a headset, form fitting cap, and earmuffs (Fig. 1 and ¶ [0055] depict a headset 230 attached to an earpiece 212) . It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover of the ear canal and tube of Fink of the above combination to incorporate that it is attached to headgear in a form selected from the group consisting of: a headset, form fitting cap, and earmuffs as taught by Smith. The motivation would have been to improve the wearability of the device. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/166127 A1 (Fink) in view of “ Sensor Array for Detection of Early Stage Parkinson’s Disease before Medication ” ( Finberg ) and US 2015/0320591 A1 (Smith), as applied to claim 18 above, and further in view of US 10,463,275 B2 (King-Smith). With regards to claim 19, the above combination is silent regarding a collector module comprising a port for a removable cartridge. In the same field of endeavor of VOC analysis, King-Smith teaches collector module comprising a port for a removable cartridge (Fig. 1 and Col. 6, lines 18-28, 40-51 depict a liquid collector 710 being removable; Fig. 2 and Col. 8, lines 16-17 disclose an Airtight Gasket 622 which allows the Ionic Liquid Collector to be inserted and removed from the Concentrator. ) It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate collector module comprising a port for a removable cartridge as taught by King-Smith. The motivation would have been to allow for the sample to be sent to a laboratory for additional analysis (Col. 6, lines 21-23 of King-Smith). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SAMUEL C KIM whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8637 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00 AM - 5:00 PM EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Jacqueline Cheng can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-5596 . 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. /S.C.K./ Examiner, Art Unit 3791 /JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Sep 11, 2023
Application Filed
Mar 18, 2026
Non-Final Rejection — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
48%
Grant Probability
99%
With Interview (+71.5%)
4y 0m
Median Time to Grant
Low
PTA Risk
Based on 221 resolved cases by this examiner. Grant probability derived from career allow rate.

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