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 .
Specification
The use of the term BLUETOOTH® in [00966] and [001020], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 12 – 16, 23, and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 (line 3) recites the term “prevent the electronic modules”. It is unclear if these are intended to be the same or different than the previously-recited “plurality of electronic modules”. For the purposes of examination, the term “prevent the electronic modules” is deemed to claim “prevent the plurality of electronic modules”.
Claim 14 recites the term “the cross-sectional shape of the collimator”. There is insufficient antecedent basis for this term in the claim. There is no previously-recited cross-sectional shape of the collimator. For the purposes of examination, the term “the cross-sectional shape of the collimator” is deemed to claim “a cross-sectional shape of the collimator”.
The term “a cross-sectional shape which is substantially similar to the cross-sectional shape of the collimator” in each of claim 12 (lines 3 - 4) and Claim 14 (lines 3 - 4) is a relative term which renders the claim indefinite. The term “substantially similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Looking to [001023] in Applicant’s specification, the use of “substantially similar” is described as “Like the collimator 12030, the desiccant 12034 can have a cross-sectional shape selected from the group consisting of conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof. In this way, the cross-sectional shape of the desiccant 12034 can be substantially similar to the cross-sectional shape of the collimator 12030.” It remains unclear if “substantially similar” is choosing the same shape from each group, or if choosing any of these options is sufficient, as these shapes in the group are considered to be “substantially similar” to each other. For the purposes of examination (and given the interpretation above), the term “a cross-sectional shape which is substantially similar to the cross-sectional shape of the collimator” is deemed to claim “a desiccant cross-sectional shape which is complementary to a cross-sectional shape of the collimator.”
Regarding Claim 13 (line 2), the term “approximately half-conical and half-cylindrical shape” is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how qualitatively or quantitatively close to half-conical and half-cylindrical a shape must be in order to be “approximately” as such. For the purposes of examination, the term “approximately half-conical and half-cylindrical shape” is deemed to claim “half-conical and half-cylindrical shape.” Claim 14 is similarly rejected due to its dependence on Claim 13.
Regarding Claim 15 (line 2), the term “a central axis of the circuit board is approximately offset from the distal portion” is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far offset the central axis must be from the distal portion in order to be “approximately” offset. For the purposes of examination, the term “a central axis of the circuit board is approximately offset from the distal portion” is deemed to claim ““a central axis of the circuit board is offset from the distal portion.”
Regarding Claim 16 (lines 1 - 2), the term “the circuit board has an approximate center point which is not axially aligned with the collimator” is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far offset the center point for it to be approximately a center point, and it is then further unclear what specific point is not axially aligned with the collimator. For the purposes of examination, the term “the circuit board has an approximate center point which is not axially aligned with the collimator” is deemed to claim “the circuit board has a center point which is not axially aligned with the collimator.”
Claim 23 (line 2)recites the term “the sterile zone”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “sterile zone”. For the purposes of examination, the term “the sterile zone” is deemed to claim “the sterilization zone.”
Claim 25 (line 2) recites the term “the natural bioburden of the applicator”. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “natural bioburden”. For the purposes of examination, the term “the natural bioburden of the applicator” ” is deemed to claim “a natural bioburden of the applicator”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 - 2, 4, 6 – 9, 11 – 12, 15 – 20, and 26 – 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et. al. (US 2021/0204841 A1), hereinafter Thomas.
Regarding Claim 1, Thomas discloses An assembly for delivery of an analyte sensor ([Abstract]) comprising:
a sensor control device ([0141] “sensor control device 302”) comprising:
an electronics housing ([0167] “electronics housing 304”) comprising:
a shell ([0168] “ shell 306”) having a first aperture ([0178] “the shell 306…define corresponding central apertures 504…”) and a first interface circumscribing the first aperture ([0178] “central aperture 504…”; Fig 6B; Fig. 5A—interior (bottom for this figure) face of “shell 306”; Fig 5B), and
a mount ([0178] “mount 308”) secured to the shell to define an interior space (Fig. 5A, interior space inside “mount 308” and “shell 306” enclosure), the mount ([0178] “mount 308”) having a second aperture ([0178] “define corresponding central apertures…506”; Fig. 5A “central aperture 506” on the “mount 308” piece) aligned with the first aperture ([0178] “…central apertures 504, 506…”; Fig. 5A and 5B) and
a second interface circumscribing the second aperture ([0178] “…central aperture…506”; Fig 5A—top face of “mount 308” surrounding “central aperture 506”),
wherein the first interface mates with the second interface (Fig. 5B structure shown assembled, interior (bottom) face of “shell 306” mated with top face of “mount 308” in assembly; Fig. 7B, central components of “shell 306” and “mount 308” flush) to define a first sterile barrier (Fig. 5B, fully assembled “shell 306” and “mount 308” layers central portion with no space; Fig 7B);
a first mating member ([0204] “first seal 702a’; Fig 7a) extending within at least one of the first aperture and the second aperture (Fig 7a, “first seal 702a” extending across the open extent of “central aperture 504” and “central aperture 506”),
a circuit board disposed within the electronics housing ([0177] “A printed circuit board (PCB) 502…positioned within the electronics housing 304.“)
an analyte sensor ([0169] “…a sensor 316…”; [0177] “…data signals, each of which corresponds to a sampled analyte level of the user.”) having a proximal portion ([0169] “sensor 316 is positioned within the interior of the electronics housing 304…”; Fig. 6B with the proximal portion toward “sharp hub 422”) and a distal portion ([0169] “ a sharp 318…sensor 316”; Fig. 6B with the distal portion down toward the tip of “sharp 318”), the proximal portion coupled with the circuit board ([0169] “sensor 316 is positioned within the interior of the electronics housing 304…”; Fig 6B--“sharp hub 422” holding “sensor 316” to the “electronics housing 304” with the circuit board) and the distal portion configured to extend beneath a user's skin surface to measure an analyte level in a bodily fluid ([0169] “ a sharp 318 (partially visible) used to help deliver the sensor 316 transcutaneously under a user's skin during application of the sensor control device 302.”; [0004] “Analyte monitoring systems…monitoring of bodily fluid analytes…biological sensors in contact with a bodily fluid”);
an applicator for delivery of the analyte sensor ([0184] “sensor control device 302 may be loaded into the sensor applicator 102…”; [0004] “…a sensor applicator configured to place a biological sensor into contact with a bodily fluid…”) comprising:
an applicator housing ([0181] “the housing 208”; Fig. 6B) comprising a sensor carrier ([0210] “…sensor carrier 604…”; Fig. 7B; [0181] “…applicator cap 210 may be threaded to the housing 208…”; Fig 6B) configured to secure the sensor control device ([0141] “sensor control device 302”) within an interior of the applicator housing (Fig. 7B; [0181] “…applicator cap 210 may be threaded to the housing 208…”); and
an applicator cap removably coupled to the applicator housing to seal the interior of the applicator ([0180] “ sensor applicator 102 with the applicator cap 210 coupled thereto”; Figs 6A and 6B; [0181] “The applicator cap 210 may be threaded to the housing 208…unscrewing…”);
a sharp hub ([0184] “…sharp hub 422”; Fig. 6B) removably coupled to the shell ([0168] “ shell 306”; [0184] “ the sensor control device 302 may be loaded into the sensor applicator 102 by mating the sharp hub 422 with a sensor carrier 604”)(Examiner notes Fig 5A shows components of the “shell 306” with the “sharp hub 422” not yet loaded in the assembly , also showing that they are separate parts that are broadly removably coupled.) and comprising a sharp ([0209] “the sharp 318” on “sharp hub 422”; Fig 6B) and a second mating member (Fig 7A and Fig 7B, undercut ridge on “sharp hub 422”) extending within at least one of the first aperture ([0178] “central aperture 504…”; Fig 7A and Fig 7B, undercut ridge on “sharp hub 422” extends across parallel to the opening of the first aperture such that it overlaps or extends within.) and the second aperture ([0178] “central aperture 506…”; Fig 7A and Fig 7B, undercut ridge on “sharp hub 422” extends across parallel to the opening of the second aperture such that it overlaps or extends within.) the second mating member configured to mate with the first mating member of the electronics housing ([0204] “first seal 702a’; Fig 7A and 7B, “undercut ridge on “sharp hub 422” sitting flush with “first seal 702a” in Fig 7A and flush with “member 704” that is flush with “first seal 702a” in Fig 7B)(Examiner notes to see 112(b) interpretation above) to define a second sterile barrier ([0209] “first seal 702a”; [0205] “first seal 702 a may be arranged to seal the interface between the sharp hub 422 and the top of the electronics housing 304…”; [0209] “the first and second seals 702 a,b…each create corresponding barriers at their respective sealing locations…”) )
a collimator positioned within the applicator cap ([0185] “collimator 606 is positioned within the applicator cap 210”),
a sterilization zone ([0186] “the collimator 606 may define or otherwise provide a sterilization zone 608”) configured to receive the distal portion of the analyte sensor ([0169] “…a sensor 316…”; [0177] “…data signals, each of which corresponds to a sampled analyte level of the user.”; Fig. 6B showing the “sharp 318” end of the “sensor 316” within the “sterilization zone 608”),
a third sterile barrier ([0209] “second seal 702b”), the third sterile barrier sealing an interface between the collimator and a bottom of the mount ([0206] “second seal 702 b…arranged to seal the interface between the mount 308 and the collimator 606”; [0209] “the first and second seals 702 a,b and the collimator seal 620 each create corresponding barriers at their respective sealing locations…”), and
a fourth sterile barrier ([0209] “…collimator seal 620…”; [0209] “…the collimator seal 620 each create corresponding barriers at their respective sealing locations…”), the fourth sterile barrier sealing an end of the sterilization zone ([0186] “sterilization zone 608”; ([0198] – [0199]“…collimator seal applied to the end of the collimator 606…prevent the ingress of contaminants and moisture to the sterilization zone”);
wherein the sterilization zone ([0186] “sterilization zone 608”; [0209] “the first and second seals 702 a,b and the collimator seal 620 each create corresponding barriers at their respective sealing locations…”) is defined by the collimator ([0186] “the collimator 606 may define or otherwise provide a sterilization zone 608”), the second sterile barrier ([0209] “first seal 702a”, “…seal the interface between the sharp hub 422 and the top of the electronics housing 304…”), the third sterile barrier ([0209] “second seal 702b”, “…seal the interface between the mount 308 and the collimator 606”), and the fourth sterile barrier ([0209] “…collimator seal 620…”).
Regarding Claim 2, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 2, Thomas discloses wherein the first mating member ([0204] “first seal 702a’; Fig 7a) extends from the shell ([0168] “ shell 306”; Fig 7A, “first seal 702a” extending from the top of “shell 306” ) into at least one of the first aperture ([0178] “…central aperture 504”; Fig 7A, “first seal 702a” extending across the opening of “central aperture 504”), and the second aperture ([0178] “…central aperture…506”; Fig 5B; Fig 7A, “first seal 702a” extending across the opening of “central aperture 504, which is concentric with “central aperture…506” in Figure 5B, so the “first seal 702a” is also extending across “…central aperture…506”).
Regarding Claim 4, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 4, Thomas discloses wherein the first mating member ([0204] “first seal 702a’; Fig 7a) extends from the mount (Fig. 5A and Fig. 7A “mount 308” within “electronics housing 304” with “first seal 702a” on top; Fig. 5A and Fig. 7A)(Examiner notes that when all of the components are connected, “mount 308” to “shell 306” to enclose the “electronics housing 304”, “first seal 702a” extends upward from the collective “mount 306” + “shell 306”, thereby broadly extending from the mount.) into at least one of the first aperture ([0178] “…central aperture 504”; Fig 7A, “first seal 702a” extending across the opening of “central aperture 504”), and the second aperture ([0178] “…central aperture…506”; Fig 5B; Fig 7A, “first seal 702a” extending across the opening of “central aperture 504, which is concentric with “central aperture…506” in Figure 5B, so the “first seal 702a” is also extending across “…central aperture…506”).
Regarding Claim 6, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 6, Thomas discloses wherein the fourth sterile barrier prevents moisture from passing into the collimator ([0198] “…collimator seal applied to the end of the collimator 606…”; ([0199] “the collimator seal 620…two or more layers of different materials…Tyvek...prevent the ingress of contaminants and moisture to the sterilization zone”) without preventing e-beam radiation from passing into the collimator ([0185] “collimator 606…”; [0199] “the single layer is gas permeable for the sterilization process, but is also capable of protection against moisture”).
Regarding Claim 7, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 7, Thomas discloses wherein the sterilization zone ([0186] “sterilization zone 608”) is configured to isolate the analyte sensor for low energy e-beam sterilization ([0189] “The collimator 606…configured to focus the radiation (e.g., beams, waves, energy, etc.) from the radiation sterilization 612 toward the components that are required to be sterile… allows transmission of the radiation to impinge upon and sterilize the sensor 316…prevent from…damaging the electronic components…”)
Regarding Claim 8, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 8, Thomas discloses wherein the sterilization zone ([0186] “sterilization zone 608”; Fig 7B) comprises a first sterilization zone ([0211] “cylindrical well 708”; Fig 7B) and a second sterilization zone ([0211] “the second seal 702b may extend into the sterilization zone 608 and define or otherwise provide a cylindrical well 708 sized to receive the sensor 316 and the sharp 1408 as extending from the bottom of the mount 308.”; Fig 7B)(Examiner notes that the portion inside the “second seal 702b” in Fig 7B could be the first sterilization zone that is separated as a cylindrical well 708 well from the portion outside the “second seal 702b” within “sterilization zone 608” as the second sterilization zone in Fig 7B.).
Regarding Claim 9, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 9, Thomas discloses wherein the circuit board ([0177] “A printed circuit board (PCB) 502…”) further comprises a plurality of electronic modules ([0177] “A plurality of electronic modules (not shown)… mounted to the PCB 502”) and wherein the circuit board ([0177] “A printed circuit board (PCB) 502…”) is offset from a central axis of the collimator to prevent the electronic modules from exposure to electronic beam radiation (Fig 6B, [0195] “the shield 616 may be positioned…aligned with the data processing unit 618 and the radiation source to block or mitigate radiation exposure (e.g., e-beam radiation or energy)…sensitive electronic circuitry of the data processing unit 618.”)(Examiner notes that based on its location on the left with the shield 616 and not centered on the central axis of the collimator 606, its exposure to the e-beam radiation.)
Regarding Claim 11, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 11, Thomas discloses wherein the collimator ([0185] “collimator 606…”) comprises a cross- sectional shape selected from the group consisting of circular ([0190] “sterilization zone is conical”; [0186] “the collimator 606 may define or otherwise provide a sterilization zone 608“)(Examiner notes that the cross-section of a cone is a circle), cubic, rectangular ([0190] “The sterilization zone 608 can exhibit any suitable cross-sectional sh.ape necessary to properly focus the radiation on the sensor 316…sterilization zone is conical…sterilization zone 608 may exhibit a polygonal cross-sectional shape, such as cubic, rectangular…“)(Examiner notes that since the collimator 606 is configured to “define the sterilization zone”, then it will at least a portion of it have the cross-sectional shape of the sterilization zone.) and any combination thereof.
Regarding Claim 12, Thomas discloses as described above, The assembly of claim 11. For the remainder of Claim 12, Thomas discloses further comprising a desiccant disposed in the applicator cap ([0211] “…cylindrical well 708 sized to receive the sensor 316 and the sharp 1408…extending from the bottom of the mount 308…a desiccant 710 may be positioned within the cylindrical well”; [0185] “the collimator 606 may form an integral part or extension of the applicator cap 210…“), a cross-section of the desiccant being axially aligned with a cross-section of the collimator ([0185] “collimator 606…”; [0211] “…cylindrical well 708…desiccant 710 may be positioned within the cylindrical well”; Fig 7A)(Examiner notes that the cross section would be a circle, since it is the cross section of a cylinder, and concentric within the “collimator 606”), wherein the cross-section of the desiccant comprises a cross-sectional shape which is substantially similar to the cross-sectional shape of the collimator ([0185] “collimator 606…”; [0211] “…cylindrical well 708…desiccant 710 may be positioned within the cylindrical well”, wherein the cross-section of a cylinder is a circle; [0190] “The sterilization zone 608 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation on the sensor 316…sterilization zone is conical, wherein a cross-section of a cone is a circle.)(Examiner notes that since the collimator 606 is configured to “define the sterilization zone”, then it will at least a portion of it have the cross-sectional shape of the sterilization zone.)
Regarding Claim 15, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 15, Thomas discloses wherein a central axis of the circuit board is approximately offset from the distal portion of the analyte sensor ([0200] “the sensor 316 and the sharp 318 may extend from the bottom of the electronics housing 304 eccentric to the centerline of the sensor applicator 102 and the applicator cap 210.”; [0217] “a printed circuit board arranged within the electronics housing”).
Regarding Claim 16, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 16, Thomas discloses wherein the circuit board has an approximate center point which is not axially aligned with the collimator ([0200] “the sensor 316 and the sharp 318 may extend from the bottom of the electronics housing 304 eccentric to the centerline of the sensor applicator 102 and the applicator cap 210...the collimator 606 may be…configured such that the sterilization zone 608 is also eccentrically positioned to receive the sensor 316 and the sharp 318...”; [0217] “a printed circuit board arranged within the electronics housing”)
Regarding Claim 17, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 17, Thomas discloses further comprising a microbial barrier positioned at an interface between the applicator housing and the applicator cap ([0156] “an O-ring or another type of sealing gasket may seal an interface between the housing 208 and the applicator cap 210.“)(Examiner notes that sealing the interface would be a barrier to microbes.; Fig. 2B)
Regarding Claim 18, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 18, Thomas discloses wherein the sterilization zone ([0186] “sterilization zone 608”) is bounded on a first end by a seal ([0187] “…sealed region 610 at least partially defined by the sterilization zone 608”; Fig 7A showing “sterilization zone 608” with “collimator seal 620” across the bottom of it.) and bounded on a second end by the sharp hub [0184] “…sharp hub 422”; [0187]; Fig. 6B, the “sharp hub” 422 with “sharp 318” at the top portion of “sealed region 610” of “sterilization zone 608” on the opposite end from the “collimator seal 620”)
Regarding Claim 19, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 19, Thomas discloses further comprising a further sterilization zone ([0211] ““cylindrical well 708…“; Fig 7B) which is bounded on a first end by the mount ([0178] “mount 308”; Fig 7B, “mount 308” with “second seal 702b” attached, forming the bottom of “cylindrical well 708”; [0211] “…second seal 702b may extend into the sterilization zone 608…”) and bounded on a second end by the sharp hub ([0184] “…sharp hub 422”; [0187]; Fig. 6B, the “sharp hub” 422 with “sharp 518” at the top portion of “sealed region 610” of “sterilization zone 608” on the opposite end from the “second seal 702b” of “mount 308”)
Regarding Claim 20, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 20, Thomas discloses wherein the shell further comprises a third interface ([0168] “shell 306 may be secured…such that a sealed interface therebetween is generated…”) proximate a first outer periphery and the mount ([0168] “…positioned at or near the outer diameter (periphery) of the shell 306 and the mount 308, and securing the two components together”), and the mount further comprises a fourth interface proximate a second outer periphery such that the third interface and the fourth interface are mateable to form a seal ([0168] “The shell 306 may be secured to the mount 308 via a variety of ways, such as a snap fit engagement”; Fig 5A, showing and smaller outer diameter of “mount 308” on which the inner diameter of “shell 306” would mate for a first interface, and then a perpendicular face for a bottom, upward-facing hard stop larger diameter of “mount 308”, onto which the bottom face of “shell 306” would interface when snapped together, for a second interface.)
Regarding Claim 26, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 26, Thomas discloses wherein the first sterile barrier (Fig. 5B, fully assembled “shell 306” and “mount 308” layers central portion with no space; Fig 7B); is sealed with an adhesive [0168] with “an adhesive…outer diameter (periphery) of one or both of the shell 306 and the mount 308…adhesive coupling may provide a sufficient sterile barrier for the assembled electronics housing 304.”)(Examiner notes that the adhesive around the periphery would allow for the fully-assembled configuration for Fig. 5B, sealing the interface together with proximity.
Regarding Claim 27, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 27, Thomas discloses wherein the third sterile barrier ([0209] “second seal 702b…”) is proximate a proximal portion of the collimator ([0206] “second seal 702 b…arranged to seal the interface between the mount 308 and the collimator 606”; Fig 7A)
Regarding Claim 28, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 28, Thomas discloses wherein the fourth sterile barrier([0209] “…collimator seal 620…”) is proximate a distal portion of the collimator ([0198] “…collimator seal applied to the end of the collimator 606…”)
Claims 23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et. al. (US 2021/0204841 A1) as evidenced by Wickham Micro (“Bioburden Testing Method Facts”, Ref U on PTO-892)
Regarding Claim 23, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 23, Thomas discloses wherein the first sterile barrier (Fig. 5B, fully assembled “shell 306” and “mount 308” layers central portion with no space; Fig 7B); is defined between the sterile zone and a natural bioburden of the interior space of the electronics housing (Fig. 5B, fully assembled “shell 306” and “mount 308” layers central portion with no space for “electronics housing 304”; Fig 7A and 7B)(Examiner notes that the assembly leaves a space between the “shell 306” and “mount 308” (as provided for by the in the open area with spacers in “mount 308” in Fig 5A) for the electronic components (the open area shown to the left and right in Figures 7A and 7B), with a mated barrier between the “sterilization zone 608” and the spaces for electronic components of “electronics housing 304”. Examiner further notes, that as evidenced by Wickham Micro, the “natural bioburden” is the number of microorganisms living on a non-sterilised surface or device”, such that the “natural bioburden” includes the microorganisms that are generally on the medical device surfaces. The applicator before being sterilized would have this “natural bioburden”);
Regarding Claim 25, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 25, Thomas discloses where the second sterile barrier ([0205] “first seal 702a may be arranged to seal the interface between the sharp hub 422 and the top of the electronics housing 304…”; [0209]) is defined between the natural bioburden of the applicator ([0184] “…the sensor applicator 102…”; Fig 6B”)(Examiner notes that as evidenced by Wickham Micro, the “natural bioburden” is the number of microorganisms living on a non-sterilised surface or device”, such that the “natural bioburden” includes the microorganisms that are generally on the medical device surfaces. The applicator before being sterilized would have this “natural bioburden”) and the sterilization zone ([0205] “first seal 702 a may be arranged to seal the interface between the sharp hub 422 and the top of the electronics housing 304…”; Fig. 7A and 7B—Seal between “sharp hub 422” and the top of the electronics housing 304”, which is broadly between the “sensor applicator 102” and the “sterilization zone 608”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 22, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et. al. (US 2021/0204841 A1), hereinafter Thomas, in view of Thomas Embodiment 4402 (US 2021/0204841 A1, including Figure 45 and 46B), hereinafter Thomas Embodiment 4402.
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Figure A: Examiner-Annotated Side-By-Side comparison of Feature 702a in Thomas Embodiment of Figure 7A and the “recessed portion of the shell 4406” in Embodiment 4402 of Thomas Figure 46B.
Regarding Claim 3, Thomas discloses as described above, The assembly of claim 2. For the remainder of Claim 3, Thomas discloses the first mating member ([0204] “first seal 702a’; Fig 7a) and is on a surface of the shell (Fig 7a – “first seal 702a on the top surface of “ shell 306”)
Thomas does not particularly disclose wherein the first mating member is a recessed surface of the shell. In regard to looking to other embodiments, Thomas does disclose at [0560] “The sensor control device 4402 may be similar in some respects to the sensor control device 104 of FIG. 1… the sensor control device 4402 may replace the sensor control device 104 and, therefore, may be used in conjunction with the sensor applicator 102 of FIG. 1, which may deliver the sensor control device 4402 to a target monitoring location on a user's skin.”
Thomas Embodiment 4402 teaches wherein the first mating member ([0582] “…recessed portion of the shell 4406”) is a recessed surface of the shell ([0582] “the top surface where the sharp hub 4414 engages the shell 4406 comprises a recessed portion of the shell 4406…”; Fig 46B).
Thomas Embodiment 4402 provides a motivation to combine at [0582] with “…the top surface where the sharp hub 4414 engages the shell 4406 comprises a recessed portion of the shell 4406, but could alternatively comprise an upper surface that is level with adjacent portions of the shell 4406.” The similar surface interface of “first seal 702a” is relative to a flat surface on “shell 306”, which Thomas Embodiment 4402 teaches is an alternative surface interface to the recessed one. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that recessed mate of two surfaces to make a seal is a well-known method of connecting components, and that a recessed mate is useful for aligning components during assembly. It would have been predictable to use the recessed mate interface for the shell as taught by Thomas 4400 in any similar sharp hub/shell interface, as it would continue to operate with the function of creating a seal between the sharp hub and the shell. Thomas teaches that the embodiments can be combined at [1008] with “It is therefore evident that the particular illustrative embodiments disclosed above may be altered, combined, or modified and all such variations are considered within the scope of the present disclosure.”
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute Thomas’ disclosed flat interface of the “first seal 702a” mate with the top surface of “shell 306” to form a seal between the sharp hub and the shell with Thomas 440 embodiment’s recessed top surface of the shell mate, creating a single mating interface within the analyte sensing assembly that forms a seal between the sharp hub and the shell and can be reliably assembled due to indexing the parts using the recess. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 22, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 22, Thomas discloses the first (Fig. 5A—interior (bottom for this figure) face of “shell 306”; Fig 5B) and second interface (Fig 5A—top face of “mount 308” surrounding “central aperture 506”),
Thomas does not particularly disclose wherein one of the first and second interface comprises an annular ridge, and the other of the first and second interface comprises a channel configured to receive the annular ridge.
Thomas Embodiment 4402 teaches wherein one of the first and second interface comprises an annular ridge (Fig 45 with “annular ridge” on top face of “shell 4406”; [0569] “…annular ridge 4510 that circumscribes the sharp and sensor locator 4502”); and the other of the first and second interface comprises a channel configured to receive the annular ridge ([0569] “…shell 4406 and the mount 4408 are mated, the annular ridge 4510 may juxtapose an opposing surface defined on the bottom of the mount 4408.”)
Thomas Embodiment 4402 provides a motivation to combine at [0569] with “The seal members 4508a,b may comprise, for example, an adhesive or a gasket, and each may help secure the shell 4406 to the mount 4408 and seal the interface between the two components, and thereby isolate the interior of the electronics housing 4404 (FIG. 44) from outside contamination.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using an annular surface to make a seal, such as allowing a gasket to be used, is a well-known method of connecting components, and an annular ridge is useful for aligning parts during assembly. It would have been predictable to use the annular ridge mate interface for the seal between the shell and the mount as taught by Thomas Embodiment 4402 in any similar shell and mount connective interface, as it would continue to operate with the function of creating an interface seal between the shell and mount. Thomas teaches that the embodiments can be combined at [1008] with “It is therefore evident that the particular illustrative embodiments disclosed above may be altered, combined, or modified and all such variations are considered within the scope of the present disclosure.”
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute Thomas’ disclosed flat interface of the interior (bottom) face of “shell 306” mated with top face of “mount 308” in assembly to secure the components with Thomas Embodiment 4402’s taught annular ridge interface to connect seal interface members, creating a single mating interface to secure the shell to the mount and seal the interface between the two components. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
In the interest of compact prosecution, such that the adhesive is intended to be applied directly to the first sterile barrier interface, an alternative rejection is provided.
Regarding Claim 26, Thomas discloses, as described above, The assembly of claim 1. For the remainder of Claim 26, Thomas discloses the first sterile barrier (Fig. 5B, fully assembled “shell 306” and “mount 308” layers central portion with no space; Fig 7B);
Thomas does not specifically disclose that the adhesive is applied directly to the barrier itself to seal it.
Thomas Embodiment 4402 teaches wherein the first sterile barrier ([0569] “…shell 4406 and the mount 4408 are mated, the annular ridge 4510 may juxtapose an opposing surface defined on the bottom of the mount 4408.”) is sealed with an adhesive ([0569] “…seal members 4508a,b…an adhesive or a gasket, and each may help secure the shell 4406 to the mount 4408 and seal the interface between the two components…”)
Thomas is open to the inclusion of an adhesive when securing the interface between “shell 306” and “mount 308” at [0168] with “an adhesive…outer diameter (periphery) of one or both of the shell 306 and the mount 308…adhesive coupling may provide a sufficient sterile barrier for the assembled electronics housing 304.”). Thomas Embodiment 4402 provides a motivation to combine at [0569] with “The seal members 4508a,b may comprise, for example, an adhesive or a gasket, and each may help secure the shell 4406 to the mount 4408 and seal the interface between the two components, and thereby isolate the interior of the electronics housing 4404 (FIG. 44) from outside contamination.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that adhering two surfaces to make a seal is a well-known method of connecting components, and that adhesive is useful for ensuring that components stay directly mated without gapping. It would have been predictable to use the adhesive mate interface for the seal as taught by Thomas Embodiment 4402 in any similar shell and mount connective interface, as it would continue to operate with the function of creating an interface seal between the shell and mount. Thomas teaches that the embodiments can be combined at [1008] with “It is therefore evident that the particular illustrative embodiments disclosed above may be altered, combined, or modified and all such variations are considered within the scope of the present disclosure.”
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute Thomas’ disclosed flat interface of the interior (bottom) face of “shell 306” mated with top face of “mount 308” and adhesive to “shell 306” and “mount 308” to secure the components with Thomas Embodiment 4402’s taught adhesive applied directly to seal interface members, creating a single mating interface to secure the shell to the mount and seal the interface between the two components. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et. al. (US 2021/0204841 A1), hereinafter Thomas, in view of Thomas et. al. (US 2021/0161437 A1), hereinafter Thomas ‘437.
Regarding Claim 13, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 13, Thomas discloses the collimator ([0185] “collimator 606…”)
Thomas does not particularly disclose comprises a shape which is an approximately half-conical and half-cylindrical shape. Thomas is open to combine with different collimator geometry, however, given [0190] with “The sterilization zone 608 can exhibit any suitable cross-sectional shape necessary to properly focus the radiation on the sensor 316…may exhibit a polygonal cross-sectional shape…without departing from the scope of the disclosure.”
Thomas ‘437 teaches a sensor applicator system that is similar to that of Thomas ‘841 in form, with a particular embodiment that includes a bi-level collimate that is conical at the bottom and cylindrical at the top (Figure 14B; [Abstract]). Specifically for Claim 13, Thomas ‘437 teaches comprises a shape which is an approximately half-conical and half-cylindrical shape (Fig 14B, including a collimator which is conical on the bottom half with “external collimator 1418” and cylindrical on the top half “internal collimators 1420” of the overall collimator structure.) .
Thomas ‘437 provides a motivation to combine at [0266] with “The external and internal collimators 1418, 1420 may cooperatively define a sterilization zone 1424 that focuses the radiation 1412 and into which the distal ends of the sensor 1316 and the sharp 1318 may be positioned.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that angling collimators can be useful for focusing radiation toward particular components during sterilization, such as the sharp.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Thomas’ disclosed cylindrical collimator (that is disclosed to “exhibit any suitable cross-sectional shape necessary to properly focus the radiation on the sensor 316” with the more focused shape of the part-conical, part-cylindrical collimator taught by Thomas ‘437, creating a single collimator within an analyte monitoring system assembly that can specifically focus the radiation on the sensor during sterilization.
Regarding Claim 14, Thomas discloses as described above, The assembly of claim 13. For the remainder of Claim 14, Thomas discloses further comprising a desiccant disposed in the applicator cap ([0211] “…cylindrical well 708 sized to receive the sensor 316 and the sharp 1408…extending from the bottom of the mount 308…a desiccant 710 may be positioned within the cylindrical well”; [0185] “the collimator 606 may form an integral part or extension of the applicator cap 210…“), a cross-section of the desiccant being axially aligned with a cross-section of the collimator ([0185] “collimator 606…”; [0211] “…cylindrical well 708…desiccant 710 may be positioned within the cylindrical well”),
wherein the cross-section of the desiccant comprises a cross-sectional shape which is substantially similar to the cross-sectional shape of the collimator ([0185] “collimator 606…”; [0211] “…cylindrical well 708…desiccant 710 may be positioned within the cylindrical well”, wherein the cross-section of a cylinder is a circle, like the top part of the collimator in the combination of Thomas with Thomas ‘437 for Claim 13.)(Examiner notes that at [001023] in Applicant’s specification, the use of “substantially similar” is described as “Like the collimator 12030, the desiccant 12034 can have a cross-sectional shape selected from the group consisting of conical, frustoconical, pyramidal, circular, cubic, rectangular, and any combination thereof. In this way, the cross-sectional shape of the desiccant 12034 can be substantially similar to the cross-sectional shape of the collimator 12030.” In the combination of Thomas with Thomas ‘437 for Claim 13, the top part of the collimator is cylindrical in shape, which would allow for the “cylindrical well 710” to exist and be filled with desiccant as disclosed in Thomas.)
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas et. al. (US 2021/0204841 A1), hereinafter Thomas, in view of Thomas Embodiment 1200 (US 2021/0204841 A1, including Figure 8), hereinafter Thomas Embodiment 1200.
Regarding Claim 24, Thomas discloses as described above, The assembly of claim 1. For the remainder of Claim 24, Thomas discloses the second sterile barrier ([0205] “first seal 702 a may be arranged to seal the interface between the sharp hub 422 and the top of the electronics housing 304…”; [0209] “the first and second seals 702 a,b…each create corresponding barriers at their respective sealing locations…”)
Thomas does not particularly disclose is a tortuous path.
Thomas Embodiment 1200 teaches is a tortuous path ([0254] “the assembly 1200 may further include a barrier shield 824 positioned… within the housing 1204.”; [0254] “the barrier shield 824 may provide a tortuous pathway that allows the radiation sensitive component 1208 to exit the housing 1204 via the part 1206.”) Thomas Embodiment 1200 provides a motivation to combine at [0254] with “the assembly 1200 may further include the barrier shield 824 positioned to help block radiation 814 (e.g., electrons) from propagating within the housing 1204 toward the radiation sensitive component 1208.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a “barrier shield” tortuous path would be useful at a sealing barrier to provide a radiation sensitive components from e-beam radiation during sterilization. Thomas teaches that the embodiments can be combined at [1008] with “It is therefore evident that the particular illustrative embodiments disclosed above may be altered, combined, or modified and all such variations are considered within the scope of the present disclosure.”
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the sealing “barrier” interface between the sharp hub 422 and the top of the electronics housing 304 disclosed by Thomas, with the barrier shield tortuous path taught by Thomas Embodiment 1200, creating a single sealing barrier region to help direct radiation away from sensitive electronics within the housing.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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