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
Claim 16 objected to because of the following informalities:
In claim 16, “a activated carbon” should read “an activated carbon.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 23, it states “the molecular sieve has an average pore size of >10 angstroms & selectively absorbs siloxanes outgassed from elastomeric components within the chamber.” Paragraphs 0265-0267 within the specification discusses the scavenger material being used to absorb substances like siloxanes outgassed from elastomeric components within the chamber, but it does not specify that the molecular sieve is absorbing the outgassed substances within the chamber. Therefore, Claim 23 introduces new matter.
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.
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 1-3, 5, 7-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (EP 3771451 A1) in view of Brister et al. (US 8452368 B2) and Falasco (US 20060200037 A1).
Regarding Claim 1, Chang discloses an analyte measurement device (sensor assembly – element 70) comprising:
an analyte sensor (sensor – element 72) configured to measure an analyte level, the analyte sensor including a tail portion for subcutaneous placement, the tail portion having an analyte-responsive enzyme (Figure 28A; Paragraph 0025; [Examiner’s note, one skilled in the art can identify the sensor (72) is a tail portion for subcutaneous placement. The sensor, within the tail portion, contains a working electrode that has an analyte-responsive enzyme. The purpose of the analyte-responsive enzyme ensures an accurate analyte level reading from the patient.]) disposed thereon;
an applicator for delivery of the analyte sensor (desiccating container – element 100), the applicator having a housing defining a hermetically-sealed chamber at least in part (Paragraph 0026), and a sharp (needle – element 362) comprising a hollow or recessed portion configured to receive at least a part of the tail portion, the tail portion disposed within the chamber prior to subcutaneous placement (Figure 4; Paragraph 0025; [Examiner’s note, a zoomed in image of figure 4 displays the sharp (362) is within the tail portion (72).]).
Chang is silent in disclosing a scavenger material disposed immediately adjacent to the tail portion and the sharp within the chamber, the scavenger material comprising a blend of scavenger materials comprising activated carbon, and at least one of molecular sieve, or silica gel, and wherein the scavenger material is structured to adsorb at least one substance within the chamber;
Brister teaches a scavenger material disposed immediately adjacent to the tail portion and the sharp within the chamber (Brister | interference domain – element 48; Figure 5C; Column 22 lines 42-46; [Examiner’s note, the interference domain containing a molecular sieve, is an internal component of the reference electrode (46), as shown in Figure 5C. The reference electrode (46) surrounds the proximal portion of the sensor (32), as shown in Figures 4A and 5B. According to Column 31 lines 62-64, The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host. Therefore, the interference domain, which contains the scavenger material (molecular sieve), is immediately adjacent to the tail portion and the sharp.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the scavenger material disposed immediately adjacent to the tail portion because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Lastly, Falasco teaches the scavenger material comprising a blend of scavenger materials comprising activated carbon, and at least one of molecular sieve, or silica gel (Falasco | Absorbent – element 136; Paragraph 0028), and wherein the scavenger material is structured to adsorb at least one substance within the chamber (Leichner | Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 2, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 1, Chang is silent on teaching the scavenger material is configured to surround the tail portion within the chamber;
Brister teaches the scavenger material is configured to surround the tail portion within the chamber (Brister | interference domain – element 48; Figure 5C; Column 22 lines 42-46; [Examiner’s note, the interference domain containing a molecular sieve, is an internal component of the reference electrode (46), as shown in Figure 5C. The reference electrode (46) surrounds the proximal portion of the sensor (32), as shown in Figures 4A and 5B. According to Column 31 lines 62-64, The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host. Therefore, the interference domain, which contains the scavenger material (molecular sieve), surrounds to the tail portion.]).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the scavenger material configured to surround the tail portion from Brister because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 3, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 1. Chang is silent in wherein the tail portion has a length, and wherein the scavenger material is configured to surround the tail portion along the length within the chamber;
Brister teaches wherein the tail portion (Brister | sensor – element 32) has a length (Brister | Figure 3, 4A and 5B; [Examiner’s note, the length of the tail portion is composes of elements 40 and 42 of the sensor (32), which make proximal portion 40 of the sensor 32.]), and wherein the scavenger material is configured to surround the tail portion along the length within the chamber (Brister | interference domain – element 48; Figure 5C; Column 22 lines 42-46; [Examiner’s note, the interference domain containing a molecular sieve, is an internal component of the reference electrode (46), as shown in Figure 5C. The reference electrode (46) surrounds the proximal portion of the sensor (32), as shown in Figures 4A and 5B. According to Column 31 lines 62-64, The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host. Therefore, the interference domain, which contains the scavenger material (molecular sieve), surrounds to the tail portion.]).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the scavenger material configured to surround the tail portion from Brister because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 5, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 1. Chang is silent in teaching a sensor sleeve configured to at least partially surround the tail portion within the chamber, the sensor sleeve including the scavenger material;
Brister teaches a sensor sleeve (Brister | reference electrode – element 46) configured to at least partially surround the tail portion within the chamber (Brister | Figure 4A and 5B), the sensor sleeve including the scavenger material (Brister | interference domain – element 48; Figure 5B-C). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the sensor sleeve and containing the scavenger material from Brister because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 7, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 5. Chang is silent in teaching the sensor sleeve comprises the scavenger material compounded with at least one polymeric material;
Brister teaches wherein the sensor sleeve (Brister | reference electrode – element 46) comprises the scavenger material (Brister | interference domain – element 48; Figure 5B-C) compounded with at least one polymeric material (Brister | resistance domain – element 50; Figure 5C; Column 25 lines 6-34).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of a resistance domain from Brister because the hydrophobic and hydrophilic polyurethane membrane controls glucose and oxygen diffusion, extending the glucose sensor life, and improving biocompatibility (Column 24 lines 6-10, hi the resistance domain 50 includes a polyurethane membrane with both hydrophilic and hydrophobic regions to control the diffusion of glucose and oxygen to an analyte sensor, the membrane being fabricated easily and reproducibly from commercially available materials).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 8, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 5. Chang in view of Brister teaches the scavenger material forms a coating over the sensor sleeve (Chang | Paragraph 0027, The desiccant 60 can be a desiccant-incorporated polymer, a water-absorbing material, a hygroscopic material, a molecular sieve drying sheet, a desiccant-incorporating plastic sheet, or a dry sheet formed by injection molding with internal components of the container 100; [Examiner’s note, a desiccant-incorporated polymer, hygroscopic material, or molecular sieve can be applied as a coating to protect surfaces from moisture and other impurities]).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 9, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 5, further comprising a sensor cap defining a sensor cap chamber (Chang | bottom cover – element 20).
Regarding Claim 10, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 9, wherein the sensor sleeve is disposed within the sensor cap chamber, and wherein the tail portion is received within the sensor sleeve and sensor cap chamber prior to subcutaneous placement (Chang | Figure 22; Paragraph 0027, The desiccant 60 may be disposed at any appropriate position inside the desiccating container 100… The desiccant 60 may also be disposed at an appropriate position of the implanting module 30 or the bottom cover 20, or the desiccant 60 may be disposed near the sensor assembly 70, or the desiccant 60 may be integrally formed with the sensor base 71).
Regarding Claim 11, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 1, further comprising an electronics housing disposed within the applicator, and a sensor cap (Chang | transmitter – element 90; Figure 28B; Paragraph 0065, after the sensor 72 is implanted under the skin surface P of the living body, the sensor assembly 70 and the base 50 that are simultaneously disposed on the skin surface P of the living body need to be equipped with the transmitter 90 to work. The transmitter 90 is used to process the physiological signals measured by the sensor 72 and allow the signals to be transmitted to the outside; [Examiner’s note, the transmitter contains the electronics housing, which is placed on the sensor assembly. The sensor assembly resides within the applicator and sensor cap.]),
the electronics housing configured to be mounted to the skin of a patient, the analyte sensor including a first portion within the electronics housing and the tail portion, wherein the tail portion extends through an aperture in the electronics housing (Chang | Figure 28B);
the sensor cap having a first end, wherein the first end is removably coupled to the electronics housing and the tail portion is received within the sensor cap chamber prior to subcutaneous placement (Chang | Figures 22 and 28B).
Regarding Claim 12, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 11. Chang in view of Brister teaches the scavenger material is disposed within the sensor cap chamber and wherein the sensor cap comprises the scavenger material (Chang | Figure 22; Paragraph 0027, The desiccant 60 may be disposed at any appropriate position inside the desiccating container 100… The desiccant 60 may also be disposed at an appropriate position of the implanting module 30 or the bottom cover 20, or the desiccant 60 may be disposed near the sensor assembly 70, or the desiccant 60 may be integrally formed with the sensor base 71… The desiccant 60 can be a desiccant-incorporated polymer, a water-absorbing material, a hygroscopic material, a molecular sieve drying sheet, a desiccant-incorporating plastic sheet, or a dry sheet formed by injection molding with internal components of the container 100) or the sensor cap comprises a compound of the scavenger material and at least one polymeric material or the scavenger material forms a coating over the sensor cap [Examiner’s note, the claim only requires one out of the group; the prior art discusses the scavenger material on the sensor cap].
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 13, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 11. Chang in view of Brister teaches the scavenger material is disposed within the electronics housing, and wherein a collar positioned within the electronics housing includes the scavenger material (Chang | Figure 22 and 28B; Paragraph 0027, The desiccant 60 may be disposed at any appropriate position inside the desiccating container 100… The desiccant 60 may also be disposed at an appropriate position of the implanting module 30 or the bottom cover 20, or the desiccant 60 may be disposed near the sensor assembly 70, or the desiccant 60 may be integrally formed with the sensor base 71… The desiccant 60 can be a desiccant-incorporated polymer, a water-absorbing material, a hygroscopic material, a molecular sieve drying sheet, a desiccant-incorporating plastic sheet, or a dry sheet formed by injection molding with internal components of the container 100) or wherein the electronics housing comprises the scavenger material or wherein the electronics housing comprises a compound of the scavenger material and at least one polymeric material or wherein the scavenger material forms a coating over the electronics housing [Examiner’s note, the claim only requires one out of the group; the prior art discusses the electronics housing includes the scavenger material].
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 14, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 1. Chang in view of Brister teaches the scavenger material is a selective scavenger material (Chang | Paragraph 0027, The desiccant 60 can be a desiccant-incorporated polymer, a water-absorbing material, a hygroscopic material, a molecular sieve drying sheet, a desiccant-incorporating plastic sheet, or a dry sheet formed by injection molding with internal components of the container 100).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 15, Chang in view of Brister and Falasco teaches the analyte measurement device of claim 1, wherein the at least one substance comprises at least one volatile organic compound (Chang | Paragraph 0027, The desiccant 60 can be a desiccant-incorporated polymer, a water-absorbing material, a hygroscopic material, a molecular sieve drying sheet, a desiccant-incorporating plastic sheet, or a dry sheet formed by injection molding with internal components of the container 100; [Examiner’s note, molecular sieves, desiccant-incorporated polymers, and hygroscopic materials can absorb both hydrophilic and hydrophobic volatile organic compounds]).
Regarding Claim 16, Chang discloses a method of packaging an analyte sensor (Paragraph 0064), the method comprising:
providing an analyte sensor (sensor – element 72) configured to measure an analyte level, the analyte sensor including a tail portion for subcutaneous placement, the tail portion having an analyte-responsive enzyme (Figure 28A; Paragraph 0025; [Examiner’s note, one skilled in the art can identify the sensor (72) is a tail portion for subcutaneous placement. The sensor, within the tail portion, contains a working electrode that has an analyte-responsive enzyme. The purpose of the analyte-responsive enzyme ensures an accurate analyte level reading from the patient.]) disposed thereon;
providing an applicator for delivery of the analyte sensor (desiccating container – element 100), the applicator having a housing defining hermetically-sealed chamber (Paragraph 0026), and a sharp (needle – element 362) comprising a hollow or recessed portion, the tail portion disposed within the chamber prior to subcutaneous placement, at least a part of the tail portion disposed within the hollow or recessed portion of the sharp (Figure 4; Paragraph 0025; [Examiner’s note, a zoomed in image of figure 4 displays the sharp (362) is within the tail portion (72).]).
Chang is silent in disclosing disposing a scavenger material disposed immediately adjacent to the tail portion and the sharp within the chamber, the scavenger material comprising a blend of scavenger materials comprising activated carbon, and at least one of molecular sieve, or silica gels, and wherein the scavenger material is configured to adsorb at least one substance within the chamber;
Brister teaches disposing a scavenger material disposed immediately adjacent to the tail portion and the sharp within the chamber (Brister | interference domain – element 48; Figure 5C; Column 22 lines 42-46; [Examiner’s note, the interference domain containing a molecular sieve, is an internal component of the reference electrode (46), as shown in Figure 5C. The reference electrode (46) surrounds the proximal portion of the sensor (32), as shown in Figures 4A and 5B. According to Column 31 lines 62-64, The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host. Therefore, the interference domain, which contains the scavenger material (molecular sieve), is immediately adjacent to the tail portion and the sharp.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the scavenger material disposed immediately adjacent to the tail portion because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Lastly, Falasco teaches the scavenger material comprising a blend of scavenger materials comprising activated carbon, and at least one of molecular sieve, or silica gel (Falasco | Absorbent – element 136; Paragraph 0028), and wherein the scavenger material is structured to adsorb at least one substance within the chamber (Leichner | Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 17, Chang in view of Brister and Falasco teaches the method of claim 16. Chang is silent in teaching the scavenger material surrounds the tail portion within the chamber;
Brister teaches the scavenger material surrounds the tail portion within the chamber (Brister | interference domain – element 48; Figure 5C; Column 22 lines 42-46; [Examiner’s note, the interference domain containing a molecular sieve, is an internal component of the reference electrode (46), as shown in Figure 5C. The reference electrode (46) surrounds the proximal portion of the sensor (32), as shown in Figures 4A and 5B. According to Column 31 lines 62-64, The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host. Therefore, the interference domain, which contains the scavenger material (molecular sieve), surrounds to the tail portion.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the scavenger material surrounding the tail portion from Brister because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 18, Chang in view of Brister and Falasco teaches the method of claim 16. Chang is silent in teaching the tail portion has a length, and wherein the scavenger material surrounds the tail portion along the length within the chamber;
Brister teaches the tail portion (Brister | sensor – element 32) has a length Brister | Figure 3, 4A and 5B; [Examiner’s note, the length of the tail portion is composes of elements 40 and 42 of the sensor (32), which make proximal portion 40 of the sensor 32.]), and wherein the scavenger material surrounds the tail portion along the length within the chamber (Brister | interference domain – element 48; Figure 5C; Column 22 lines 42-46; [Examiner’s note, the interference domain containing a molecular sieve, is an internal component of the reference electrode (46), as shown in Figure 5C. The reference electrode (46) surrounds the proximal portion of the sensor (32), as shown in Figures 4A and 5B. According to Column 31 lines 62-64, The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host. Therefore, the interference domain, which contains the scavenger material (molecular sieve), surrounds to the tail portion.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the scavenger material configured to surround the tail portion from Brister because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 20, Chang in view of Brister and Falasco teaches the method of claim 16. Chang is silent in teaching a sensor sleeve within the chamber, the sensor sleeve at least partially surrounding the tail portion within the chamber, wherein the sensor sleeve includes the scavenger material;
Brister teaches a sensor sleeve (Brister | reference electrode – element 46) within the chamber, the sensor sleeve at least partially surrounding the tail portion within the chamber (Brister | Figure 4A and 5B), wherein the sensor sleeve includes the scavenger material (Brister | interference domain – element 48; Figure 5B-C). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang to incorporate the teachings of the sensor sleeve and containing the scavenger material because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 21, Chang in view of Brister and Falasco teaches the method of claim 20, wherein the applicator includes a sensor cap defining a sensor cap chamber, and wherein disposing the scavenger material withing the chamber includes disposing the scavenger material within the sensor cap chamber (Chang | Figure 22; Paragraph 0027, The desiccant 60 may be disposed at any appropriate position inside the desiccating container 100… The desiccant 60 may also be disposed at an appropriate position of the implanting module 30 or the bottom cover 20, or the desiccant 60 may be disposed near the sensor assembly 70, or the desiccant 60 may be integrally formed with the sensor base 71).
However, Chang in view of Brister teaches the scavenger material consists of the molecular sieve, and does not incorporate the blend of activated carbon, molecular sieve, and silica gel;
Falasco teaches the scavenger material incorporates activated carbon, molecular sieve, and silica gel (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Regarding Claim 22, Chang in view of Brister and Falasco teaches the method of claim 21, wherein the sensor sleeve is disposed within the sensor cap chamber and the tail portion received within the sensor sleeve and sensor cap chamber prior to subcutaneous placement (Chang | Figure 22; Paragraph 0027, The desiccant 60 may be disposed at any appropriate position inside the desiccating container 100… The desiccant 60 may also be disposed at an appropriate position of the implanting module 30 or the bottom cover 20, or the desiccant 60 may be disposed near the sensor assembly 70, or the desiccant 60 may be integrally formed with the sensor base 71).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Chang in view of Brister, Falasco, and Kosal et al. (EP0577276A2).
Regarding Claim 23, Chang in view of Brister and Falasco teaches the method of claim 21. Chang in view of Brister is silent in teachings the scavenger material comprises the molecular sieve, which is structured to have an average pore size of less than 10 angstroms and is configured to selectively absorb siloxanes outgassed from elastomeric components within the chamber;
Falasco teaches the scavenger material comprises the molecular sieve (Falasco | Absorbent – element 136; Paragraph 0028). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister to incorporate the teachings of an absorbent material from Falasco because using absorbent materials allows physicians to accurately capture and measure targeted chemicals or particulate matter from a patient's breath. For example, by collecting exhaled nitric oxide (NO), doctors can better assess airway inflammation, enabling them to provide precise and effective treatments. (Falasco | Paragraphs 0005, 0028, 0031).
Chang in view of Brister and Falasco is silent in teaching that the molecular sieve is configured to have an average pore size of less than 10 angstroms, and to selectively absorb siloxanes outgassed from elastomeric components within the chamber;
Kosal teaches molecular sieve is configured to have an average pore size of less than 10 angstroms and is configured to selectively absorb siloxanes outgassed from elastomeric components within the chamber (Kosal | Page 3 lines 31-48; [Examiner’s note, the desiccant includes a large pore molecular sieve (10 angstroms) to absorb vapor and gases, like polydiorganosiloxane, that are present in an insulated chamber, like the insulated glass unit. Polydiorganosiloxane is a type of siloxane.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor assembly of Chang in view of Brister and Falasco to incorporate the teachings of the molecular sieve desiccant from Kosal because it can remove volatile vapers trapped within a chamber (Kosal | Page 3 lines 31-48).
Response to Arguments
Applicant’s arguments and amendments filed 12/19/2025 have been fully considered.
Regarding the Claim Objections, the amendment to Claim 10 has overcome the objection.
Regarding the 112d Rejection, canceled Claim 6 has overcome the rejection.
Regarding the 103 Rejection, the examiner agrees that Chang in view of Brister does not teach the scavenger material including a blend of activated carbon, and at least one of molecular sieve or silica gel. Due to the scope change of scavenger material, further search and consideration was required. A new reference, Falasco (US 20060200037 A1), is used to modify the sensor assembly of Chang in view of Brister because it teaches of an absorbent material, which is made up of activated carbon, molecular sieve, and silica gel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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