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 .
Election/Restrictions
Applicant’s election without traverse of Species A3, B3, and C3, Claims 1-3, 7, 10, and 21-35, in the reply filed on 01/05/2026 is acknowledged.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-3, 7, 10, and 21-35 are currently under examination.
Drawings
The drawings are objected to because Figs. 1, 3, 7, 12, 14 are blurry. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1, 24, and 31: The claim limitation “a housing configured to adhere to the skin of a subject” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “housing” coupled with functional language “configured to adhere to the skin of a subject” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “housing”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Including an adhesive or equivalents thereof, as described in Par. 67 and 70 of the disclosure filed on 05/12/2025.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 claims are generally directed towards a monitor for determining analyte concentrations. The monitor comprises a housing, a sensor body that extends from the housing into the skin of the user, and an analyte sensing region on the sensor body.
Claim(s) 1-3, 7, 10, and 21-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over MCCANLESS (US Pub. No. US 20210236028) hereinafter MCCANLESS, and further in view of Simpson (US Pat. No. 9357951) hereinafter Simpson.
Regarding claim 1, MCCANLESS discloses A monitor for determining analyte concentrations in vivo, comprising (Par. 33, Fig. 1 (analyte sensor))(Par. 161 (in vivo)):
a housing configured to adhere to the skin of a subject (Par. 35, “Sensor tail 104 protrudes from the underside of sensor housing 103 and extends through adhesive layer 105, which is adapted for adhering sensor housing 103 to a tissue surface, such as skin, according to some embodiments.”);
an elongate sensor body having a sufficient length to extend from the housing into a subcutaneous layer of the skin of the subject (Fig. 2B, sensor tail – 200)(Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 57-59 (sensor tail – 200))(Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.”).
MCCANLESS highly suggests but fails to explicitly disclose an analyte sensing region positioned on the sensor body such that when at least part of the sensor body extends into the subcutaneous layer, the analyte sensing region is configured to be held in a dermal layer of the skin of the subject while remaining completely spaced apart from the subcutaneous layer (Examiner's Note: MCCANLESS fails to explicitly indicate that the sensing region is held in the dermal layer when at least part of the sensor body extends into the subcutaneous layer) (Examiner's Note: Subcutaneous layer interpreted hereafter as over 6mm as indicated in Par. 5 of the applicant’s spec.).
However, MCCANLESS does disclose an analyte sensing region positioned on the sensor body such that when at least part of the sensor body extends into the subcutaneous layer (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose)) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor tail is capable of extending into the subcutaneous layer)) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”), the analyte sensing region is configured to be in a dermal layer of the skin of the subject while remaining spaced apart from the subcutaneous layer (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose and is capable of being in the dermal layer)) (Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor region is highly capable of being in the dermal layer)) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”).
Simpson teaches an analyte sensing region positioned on the sensor body such that when at least part of the sensor body extends into the subcutaneous layer (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”(the sensor is of a length that is capable of extending into the subcutaneous layer)) (Col. 17, lines 27-59 (anchoring)), the analyte sensing region is configured to be held in a dermal layer of the skin of the subject while remaining completely spaced apart from the subcutaneous layer (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…” (the sensing region is capable of being held in a dermal layer while being held apart from the subcutaneous layer)) (Col. 17, lines 27-59 (anchoring)).
MCCANLESS and Simpson are considered to be analogous art to the claimed invention as they are involved with analyte sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS with that of Simpson to explicitly include an analyte sensing region positioned on the sensor body such that when at least part of the sensor body extends into the subcutaneous layer, the analyte sensing region is configured to be held in a dermal layer of the skin of the subject while remaining completely spaced apart from the subcutaneous layer through the combination of references as differing sensor lengths are known in the art (Simpson (Col. 15, lines 11-19)) (MCCANLESS (Par. 36)) and it would have yielded the same or similar result of measuring analyte concentrations in the dermis (Simpson (Col. 15, lines 11-19)), predictable result of securing the device in the user (Simpson (Col. 17, lines 27-59 (anchoring))), and because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a primary facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 24, MCCANLESS discloses A monitor for determining analyte concentrations in vivo, comprising (Par. 33, Fig. 1 (analyte sensor))(Par. 161 (in vivo)):
a housing configured to adhere to the skin of a subject (Par. 35, “Sensor tail 104 protrudes from the underside of sensor housing 103 and extends through adhesive layer 105, which is adapted for adhering sensor housing 103 to a tissue surface, such as skin, according to some embodiments.”);
an elongate sensor body being of sufficient length to extend from the housing to a depth of more than 2.5 mm into the skin of the subject (Fig. 2B, sensor tail – 200)(Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 57-59 (sensor tail – 200))(Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.”).
MCCANLESS highly suggests but fails to explicitly disclose an analyte sensing region positioned on the sensor body such that when the sensor body extends to a depth of more than 2.5 mm into the skin of the subject, the analyte sensing region extends to a depth of less than 2 mm into the skin of the subject (Examiner's Note: MCCANLESS fails to explicitly indicate that the sensing region is at a depth less than 2mm when at least part of the sensor body extends more than 2.5 mm).
However, MCCANLESS does disclose an analyte sensing region positioned on the sensor body such that when the sensor body extends to a depth into the skin of the subject (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose)) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor tail is capable of extending 2.5 mm)) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”), the analyte sensing region extends to a depth of less than 2 mm into the skin of the subject (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose and is capable of extending less than 2 mm)) (Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor region is highly capable of extending less than 2mm)) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”).
Simpson teaches an analyte sensing region positioned on the sensor body such that when the sensor body extends to a depth of more than 2.5 mm into the skin of the subject (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”(the sensor is of a length that is capable of extending more than 2.5 mm)) (Col. 17, lines 27-59 (anchoring)), the analyte sensing region extends to a depth of less than 2 mm into the skin of the subject (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…” (the sensing region is capable of extending less than 2 mm)) (Col. 17, lines 27-59 (anchoring))..
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS with that of Simpson to explicitly include an analyte sensing region positioned on the sensor body such that when the sensor body extends to a depth of more than 2.5 mm into the skin of the subject, the analyte sensing region extends to a depth of less than 2 mm into the skin of the subject through the combination of references as differing sensor lengths are known in the art (Simpson (Col. 15, lines 11-19)) (MCCANLESS (Par. 36)) and it would have yielded the same or similar result of measuring analyte concentrations in the dermis (Simpson (Col. 15, lines 11-19)) and because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a primary facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 31, MCCANLESS discloses A monitor for determining analyte concentrations in vivo, comprising (Par. 33, Fig. 1 (analyte sensor))(Par. 161 (in vivo)):
a housing configured to adhere to the skin of a subject (Par. 35, “Sensor tail 104 protrudes from the underside of sensor housing 103 and extends through adhesive layer 105, which is adapted for adhering sensor housing 103 to a tissue surface, such as skin, according to some embodiments.”);
an elongate sensor body configured to extend from the housing to a distal end that is positionable in a subcutaneous layer of the skin of the subject (Fig. 2B, sensor tail – 200)(Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 57-59 (sensor tail – 200))(Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor tail is able to be positioned in the subcutaneous layer)).
MCCANLESS highly suggests but fails to explicitly disclose an analyte sensing region on the sensor body, wherein the entire analyte sensing region is positioned closer to the housing than to the distal end of the sensor body (Examiner's Note: MCCANLESS fails to explicitly indicate that the entire sensing region is positioned closer to the housing than to the distal end).
However, MCCANLESS does teach an analyte sensing region on the sensor body and varying sensor regions (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose and is capable of being in the dermal layer)) (Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.”) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”).
Simpson teaches an analyte sensing region on the sensor body, wherein the entire analyte sensing region is positioned closer to the housing than to the distal end of the sensor body (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”(differing sensor lengths and locations)) (Col. 17, lines 27-59 (anchoring)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS with that of Simpson to include an analyte sensing region on the sensor body, wherein the entire analyte sensing region is positioned closer to the housing than to the distal end of the sensor body through the combination of references as this is a known variation as differing sensor lengths are known in the art (Simpson (Col. 15, lines 11-19)) (MCCANLESS (Par. 36)) and it would have yielded the same or similar result of measuring analyte concentrations in the dermis (Simpson (Col. 15, lines 11-19)).
Regarding claim 2, modified MCCANLESS further discloses wherein the monitor is a glucose monitor configured to determine glucose concentrations in vivo (MCCANLESS (Par. 36 (glucose monitoring))).
Regarding claims 25 and 32, modified MCCANLESS discloses the device of claim 2 above, which comprises the device of claims 25 and 32. As the claims are similar, claims 25 and 32 are rejected in the same manner as claim 2.
Regarding claim 3, modified MCCANLESS fails to explicitly disclose the limitations of the claim.
However, Simpson further teaches further comprising an engagement surface that extends at least partially radially away from other portions of the sensor body to facilitate increased anchoring of the sensor body in the skin of the subject (Simpson (Col. 17, lines 27-59 (anchoring structures))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS and Simpson with that of Simpson to include further comprising an engagement surface that extends at least partially radially away from other portions of the sensor body to facilitate increased anchoring of the sensor body in the skin of the subject through the combination of references as it would have yielded the predictable result of securing the device in the user (Simpson (Col. 17, lines 27-59 (anchoring))).
Regarding claims 26 and 33, modified MCCANLESS discloses the device of claim 3 above, which comprises the device of claims 26 and 33. As the claims are similar, claims 26 and 33 are rejected in the same manner as claim 3.
Regarding claim 7, modified MCCANLESS fails to explicitly disclose the limitations of the claim.
However, Simpson further teaches wherein the engagement surface forms a wedge that increases in width as the engagement surface extends towards a distal end of the sensor body (Simpson (Col. 17, lines 27-59 (anchoring structures that are bulbous, changing diameter))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS and Simpson with that of Simpson to include wherein the engagement surface forms a wedge that increases in width as the engagement surface extends towards a distal end of the sensor body for the reasoning as indicated in claim 3 above.
Regarding claims 27, modified MCCANLESS discloses the device of claim 7 above, which comprises the device of claim 27. As the claims are similar, claim 27 is rejected in the same manner as claim 7.
Regarding claim 10, modified MCCANLESS fails to explicitly disclose the limitations of the claim.
However, Simpson further teaches wherein the sensor body is configured to extend into the skin of the subject at an angle of less than 90° relative to a bottom surface of the housing (Simpson (Col. 18, lines 5-14, “The tissue piercing element of the sensor device may be introduced subcutaneously at any of a variety of angles with respect to the mounting surface, i.e., the bottom surface of the mounting unit…” “… distal tip may extend at an angle with respect to the mounting surface of about 15°, 20°, 30°, 40°, 45°, 60°, 75°, 80°, 90°, 105°, 100°, 120°, 135°, 140°, 150°, 160°, or 165° degrees, for example.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS and Simpson with that of Simpson to include wherein the sensor body is configured to extend into the skin of the subject at an angle of less than 90° relative to a bottom surface of the housing as differing entry angles are known in the art (Simpson (Col. 18, lines 5-14)) and it would have yielded the same or similar result of penetrating the tissue at an angle.
Regarding claims 28 and 34, modified MCCANLESS discloses the device of claim 10 above, which comprises the device of claims 28 and 34. As the claims are similar, claims 28 and 34 are rejected in the same manner as claim 10.
Regarding claim 21, modified MCCANLESS fails to explicitly disclose the limitations of the claim.
However, Simpson further teaches wherein when at least part of the sensor body extends into the subcutaneous layer (Simpson (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”(the sensor body is of a length that is capable of extending into the subcutaneous layer)) (Col. 17, lines 27-59 (anchoring))), the analyte sensing region extends to a depth of less than 2 mm into the skin of the subject (Simpson (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS and Simpson with that of Simpson to include wherein when at least part of the sensor body extends into the subcutaneous layer, the analyte sensing region extends to a depth of less than 2 mm into the skin of the subject for the reasoning as indicated in claim 1 above.
Regarding claim 35, modified MCCANLESS discloses the device of claim 21 above, which comprises the device of claim 35. As the claims are similar, claim 35 is rejected in the same manner as claim 21.
Regarding claim 22, modified MCCANLESS fails to explicitly disclose the limitations of the claim.
However, MCCANLESS does teach varying sensing regions (MCCANLESS (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose and is capable of being in the dermal layer)) (Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.”) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”)).
Simpson further teaches wherein the entire analyte sensing region is positioned closer to the housing than to a distal end of the sensor body (Simpson (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”(differing sensor lengths and locations))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS and Simpson with that of Simpson to include wherein the entire analyte sensing region is positioned closer to the housing than to a distal end of the sensor body as this is a known variation as differing sensor lengths are known in the art (Simpson (Col. 15, lines 11-19)) (MCCANLESS (Par. 36)) and it would have yielded the same or similar result of measuring analyte concentrations in the dermis (Simpson (Col. 15, lines 11-19)).
Regarding claim 23, modified MCCANLESS further discloses wherein the sensor body is of sufficient length to extend from the housing to a depth of more than 6 mm into the skin of the subject (MCCANLESS (Fig. 2B, sensor tail – 200)(Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 57-59 (sensor tail – 200))(Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.”)).
Regarding claim 29, modified MCCANLESS discloses the device of claim 23 above, which comprises the device of claim 29. As the claims are similar, claim 29 is rejected in the same manner as claim 23.
Regarding claim 30, modified MCCANLESS fails to explicitly disclose the limitations of the claim (Examiner's Note: MCCANLESS fails to explicitly indicate that the sensing region is at a depth between 1-2 mm when at least part of the sensor body extends more than 2.5 mm).
However, MCCANLESS does disclose wherein when the sensor body extends to a depth into the skin of the subject (MCCANLESS (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose)) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor tail is capable of extending 2.5 mm)) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”)), the analyte sensing region extends to a depth of between 1 mm and 2 mm into the skin of the subject (MCCANLESS (Fig. 2B, sensor tail – 200) (Par. 55-58 (sensing element – 218 detects glucose and is capable of extending between 1-2mm)) (Par. 36, “Sensor tail 104 is adapted to be at least partially inserted into a tissue of interest, such as within the dermal or subcutaneous layer of the skin...”) (Par. 60, “In some embodiments, the sensor tail of the analyte sensors described herein may have a length extending from the base of the external component of the analyte sensor within a range of less than about 20 millimeters (mm), such as in the range of about 1 mm to about 15 mm, or about 1 mm to about 7 mm, encompassing any value and subset therebetween. Longer sensor tails are also possible and may be inserted into a tissue at an angle in some embodiments.” (the sensor region is highly capable of extending between 1 and 2 mm)) (Par. 192, “As described above, when positioning an analyte sensor onto the skin of a wearer, a needle or other introducer is used to puncture the skin and allow transcutaneous implantation through the dermal region. Implantation may extend only to the dermis, or through to the subcutis.”)).
Simpson teaches wherein when the sensor body extends to a depth of more than 2.5 mm into the skin of the subject (Simpson (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…”(the sensor body is of a length that is capable of extending more than 2.5 mm)) (Col. 17, lines 27-59 (anchoring))), the analyte sensing region extends to a depth of between 1 mm and 2 mm into the skin of the subject (Simpson (Col. 15, lines 11-19, “In other embodiments, the in vivo portion 160 of the sensor device 100 may have a length that allows for at least a portion of the sensor body 120 to reside in the dermis layer. This may be desirable in some instances because the dermis is well vascularized, as compared to the subcutaneous layer, and thus can provide sufficient analytes (e.g., glucose) for measurement and reduce measurement lags associated with changes of analyte concentrations of a host, such as those that occur after meals…” (the sensing region is capable of extending between 1-2 mm)) (Col. 17, lines 27-59 (anchoring))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of MCCANLESS and Simpson with that of Simpson to explicitly include wherein when the sensor body extends to a depth of more than 2.5 mm into the skin of the subject, the analyte sensing region extends to a depth of between 1 mm and 2 mm into the skin of the subject for the reasoning as indicated in claim 24 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791