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 10 is objected to because of the following informalities:
In claim 10, “a sensor sleeve” should read “the sensor sleeve.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 does not further limit claim 5 because claim 5 already discusses sensor sleeve includes the scavenger material. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 5-18, 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).
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).]); and
the scavenger material comprising at least one of activated carbon, molecular sieve (Paragraph 0027, The desiccant 60 may also be disposed at an appropriate position of the implanting module 30…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), and silica gel [Examiner’s note, the claim only requires one out of the group. The prior art utilizes molecular sieve out of the listed materials.] and configured to adsorb at least one substance within the chamber (Paragraph 0026, The sensor 72 be kept airtight and dry while storage and before implantation, so the accommodating space 14 of the airtight desiccating container 100 for carrying the sensor assembly 70 is provided with the desiccant 60 to maintain the long-term stability period of the reagent, such as one or more years… the desiccant 60 maintains a good function for moisture absorption).
Chang fails to explicitly disclose a scavenger material disposed immediately adjacent to the tail portion and the sharp 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).
Regarding Claim 2, Chang in view of Brister teaches the analyte measurement device of claim 1, Chang is silent on 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 because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Regarding Claim 3, Chang in view of Brister 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 because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Regarding Claim 5, Chang in view of Brister 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 because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Regarding Claim 6, Chang in view of Brister teaches the analyte measurement device of claim 5. Chang is silent in teaching the sensor sleeve comprises the scavenger material; Brister teaches the sensor sleeve (Brister | reference electrode – element 46) comprises 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).
Regarding Claim 7, Chang in view of Brister 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).
Regarding Claim 8, Chang in view of Brister teaches the analyte measurement device of claim 5, wherein 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]).
Regarding Claim 9, Chang in view of Brister 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 teaches the analyte measurement device of claim 9, further comprising a sensor sleeve disposed within the sensor cap chamber, 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).
Regarding Claim 11, Chang in view of Brister 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 teaches the analyte measurement device of claim 11, wherein 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].
Regarding Claim 13, Chang in view of Brister teaches the analyte measurement device of claim 11, wherein 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].
Regarding Claim 14, Chang in view of Brister teaches the analyte measurement device of claim 1, wherein 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).
Regarding Claim 15, Chang in view of Brister 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).]); and
the scavenger material comprising at least one of activated carbon, molecular sieve, (Paragraph 0027, The desiccant 60 may also be disposed at an appropriate position of the implanting module 30…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) and silica gel [Examiner’s note, the claim only requires one out of the group. The term of “at least one of” warrants the scavenger material to comprise of activated carbon, molecular sieve, or silica gel] and configured to adsorb at least one substance within the chamber(Paragraph 0026, The sensor 72 be kept airtight and dry while storage and before implantation, so the accommodating space 14 of the airtight desiccating container 100 for carrying the sensor assembly 70 is provided with the desiccant 60 to maintain the long-term stability period of the reagent, such as one or more years… the desiccant 60 maintains a good function for moisture absorption).
Chang fails to explicitly disclose a scavenger material disposed immediately adjacent to the tail portion and the sharp 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).
Regarding Claim 17, Chang in view of Brister 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 because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Regarding Claim 18, Chang in view of Brister 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 because the scavenger material prevents damage to the electrodes from external environments (Brister | Column 13 lines 13 – 49).
Regarding Claim 20, Chang in view of Brister 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).
Regarding Claim 21, Chang in view of Brister 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).
Regarding Claim 22, Chang in view of Brister 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).
Conc--lusion
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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