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 .
Drawings
The drawings are objected to because in Fig. 6, reference numerals 15 and 16 on the right-hand side are reversed. Per the specification at [0043] and the list of reference numbers, 15 is the inner sealing element (smaller radial distance from transcutaneous element 2) and 16 is the outer sealing element. The left-hand side of Fig. 6 is consistent with that description; the right-hand side is not.
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 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 1, 3-4, 9 and 11-13 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 1 recites "the body-wearable medical device housing" in line 9. Claim 1 previously recites “a housing.” There is insufficient antecedent basis for “the body-wearable medical device housing.” It is unclear whether that phrase refers to the recited housing.
Claim 1 recites “has an adhesive for configured to adhere” in line 8. The phrase is grammatically incomplete, and it is not reasonably certain what is required.
Claims 3, 4 and 9 recite “the base portion." There is insufficient antecedent basis for this limitation in these claims. Claim 9 recites both “the base portion” and “the base” in the same limitation, so it is unclear whether those are the same element.
Claims 9 and 11 recite “the skin of the user.” There is insufficient antecedent basis for “the user.” Claim 1 recites a patient.
Claim 12 recites “comprises plaster that carries the adhesive.” It is unclear whether plaster is a material or a distinct structural layer.
Claim 13 recites “the inner enclosure segments and outer enclosure segments” but depends from claim 1. Claim 1 does not recite inner or outer enclosure segments. There is insufficient antecedent basis. Claim 6 introduces “inner enclosure segments” and “outer enclosure segments.” Claim 13 should depend from claim 6 in order to maintain proper antecedent basis.
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.
Claims 1-6, 8, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 12,186,098, hereinafter “Rodriguez”, in view of US Patent No. 5,203,806, hereinafter “Broida”.
Regarding claim 1, Rodriguez discloses a body-wearable medical device (medical device 100 in figs. 1-2; col. 5, lines 1-5), comprising:
a housing (sensor base 108 in figs. 1-2) having a transcutaneous element (glucose sensor 106 in figs. 1-2) configured to be at least partially inserted into a patient's body at an insertion site during use of the body-wearable medical device (glucose sensor 106 is inserted into the body of the user through central bore 144; col. 5, lines 28-36); and
a base (coupling system 104 with first adhesive member 130 and second adhesive member 131 in figs. 1-2) configured for reversibly attaching the body-wearable medical device housing to a patient's skin (second adhesive member 131 couples the physiological characteristic sensor assembly 102 to the user in fig. 2; col. 8, lines 4-6; Broida: pad can be removed by releasing adhesive layer from skin; col. 8, lines 34-35);
wherein the base has a first side (side 162b of skin adhesive layer 162 in fig. 2) that during use of the body-wearable medical device faces the patient's body and that also has an adhesive for configured to adhere the body-wearable medical device housing to the patient's skin (adhesive applied to side 162b for coupling to user anatomy in fig. 2; col. 8, lines 16-23);
wherein the base on its first side at least one fluid channel (main channel 136 around hub 134 and intermediate channels 142a-142d in fig. 3; col. 6, lines 30-37) configured to guide body fluid from the insertion site (main channel 136 and intermediate channels 142a-142d direct fluid away from central bore 144 and sensor 106).
Rodriguez fails, however, to explicitly disclose that the base is configured for reversibly attaching the body-wearable medical device housing to a patient's skin. Rodriguez also fails to disclose that the base on its first side has a superabsorbent substance.
Broida teaches that the base is configured for reversibly attaching the body-wearable medical device housing to a patient's skin (Broida: pad can be removed by releasing adhesive layer from skin; col. 8, lines 34-35) and that the base on its first side has a superabsorbent substance (Broida: super absorbent polymer (SAP) laminate pad layer 32/51/core C in figs. 2-4; col. 6, lines 25-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first side of the adhesive base of Rodriguez to include the superabsorbent substance, as taught by Broida, in order to absorb and retain leaked fluid around the transcutaneous opening and thereby keep the fluid from wetting the adhesive, impairing attachment of the patch to the skin, or contaminating the user’s clothing.
Regarding claim 2, modified Rodriguez discloses the body-wearable medical device according to claim 1 comprising a superabsorbent substance and a transcutaneous element (glucose sensor 106 in figs. 1-2).
Modified Rodriguez fails, however, to disclose that the superabsorbent substance at least partially circumscribes the transcutaneous element.
Broida teaches a superabsorbent substance at least partially circumscribes (Broida: SAP is placed as a continuous line on the first side outboard of 142a-d so that it creates a continuous ring; Rodriguez’s first adhesive member 130 already surrounds bore 144 in hub 134 along with section 132a-d, main channel 136, and intermediate channels 142a-d in fig. 3) the transcutaneous element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the superabsorbent substance added to the first side of the adhesive base of modified Rodriguez to be arranged as a continuous line outboard of intermediate channels 142a-d, as taught by Broida’s SAP core C surrounding opening 12, in order to at least partially circumscribe the transcutaneous element so fluid leaving the channels is collected around the insertion site rather than only at isolated points.
Regarding claim 3, modified Rodriguez discloses the body-wearable medical device according to claim 1, wherein the superabsorbent substance (Broida: super absorbent polymer (SAP) laminate pad layer 32/51/core C in figs. 2-4; col. 6, lines 25-29) forms an enclosure on the first side of the base portion (side 162b of skin adhesive layer 162 in fig. 2) and circumscribes the transcutaneous element (continuous line of SAP around intermediate channels 142a-d and section 132a-d circumscribe glucose sensor 106 and hub 134/bore 144; space in channels 136 and 142a-d are enclosed within SAP ring).
Regarding claim 4, modified Rodriguez discloses the body-wearable medical device according to claim 1, wherein the superabsorbent substance (Broida: super absorbent polymer (SAP) laminate pad layer 32/51/core C in figs. 2-4; col. 6, lines 25-29) on the first side of the base portion (side 162b of skin adhesive layer 162 in fig. 2) forms a discontinuous enclosure formed by multiple enclosure segments that are spaced from each other along a first virtual enclosure (four intermediate channels 142a-d are spaced around hub 134/bore 144 in fig. 3; SAP is placed as discrete pieces at the outer end of 142, so the pieces sit on that same virtual ring and are spaced from each other).
It would have been obvious to arrange the SAP of the claim 1 combination as discrete pieces at the outer ends of intermedaiate channels 142a-d of Rodriguez, because that is where those channels already discharge fluid.
Regarding claim 5, modified Rodriguez discloses the body-wearable medical device according to claim 1, wherein the superabsorbent substance (Broida: super absorbent polymer (SAP) laminate pad layer 32/51/core C in figs. 2-4; col. 6, lines 25-29) on the first side of the base (side 162b of skin adhesive layer 162 in fig. 2) forms a continuous or discontinuous inner enclosure (cut-outs 212a-d are spaced around bore hub 134/bore 144 and sit on main channel 136; fluid is channeled away from sensor assembly 102 through cut-outs 212a-d and directed to ambient environment in fig. 5; col. 9, lines 47-52) and a continuous or discontinuous outer enclosure (continuous line of SAP around intermediate channels 142a-d and section 132a-d circumscribe glucose sensor 106 and hub 134/bore 144).
It would have been obvious to arrange that same SAP as an inner enclosure at channel 136/ cut-outs 212 and an outer enclosure outboard of channels 142, because Rodriguez already moves fluid along that inner-to-outer path.
Regarding claim 6, modified Rodriguez discloses the body-wearable medical device according to claim 1, wherein the superabsorbent substance (Broida: super absorbent polymer (SAP) laminate pad layer 32/51/core C in figs. 2-4; col. 6, lines 25-29) on the first side of the base (side 162b of skin adhesive layer 162 in fig. 2) forms a discontinuous inner enclosure having multiple inner enclosure segments (second end 426 of first portion 420 of cut-outs 412a-d are spaced around bore hub 134/bore 144 and sit on main channel 136; fluid is channeled away from sensor assembly 102 in fig. 7; col. 13, line 42-65; Broida’s SAP can be attached at first portion 420 to absorb fluid) and a discontinuous outer enclosure having multiple outer enclosure segments (fourth end 430 of second portion 422 of cut-outs 412a-d are spaced around bore hub 134/bore 144 and extend beyond and across the respective intermediate channel 142a-142d of the first adhesive member 130; fluid is channeled away from sensor assembly 102 in fig. 7; col. 13, line 65 - col. 14, line 18; Broida’s SAP can be attached at second portion 422 to absorb fluid), wherein the multiple inner enclosure segments and the multiple outer enclosure segments are alternately arranged with respect to an angular position relative to the transcutaneous element along a first virtual enclosure and along a second virtual enclosure (second end 426 of first portion 420 and fourth end 430 of second portion 422 are arranged by alternate angular position along inner and outer virtual enclosures).
It would have been obvious to arrange that SAP as inner segments at 420/426 and outer segments at 422/430 of Fig. 7, because those cut-outs are already on 136 and 142 and sit at different angles around the sensor.
Regarding claim 8, modified Rodriguez discloses the body-wearable medical device according to claim 1 comprising the first side of the base (side 162b of skin adhesive layer 162 in fig. 2).
Modified Rodriguez fails, however, to disclose that the first side of the base further comprises an outer seal that circumscribes the superabsorbent substance on a side of the superabsorbent substance facing away from the transcutaneous element.
Broida teaches an outer seal (Broida: liquid-impermeable peripheral border 11 in fig. 4) that circumscribes the superabsorbent substance on a side of the superabsorbent substance facing away from the transcutaneous element (Broida: super absorbent polymer (SAP) laminate pad layer 32/51/core C is encircled by liquid-impermeable peripheral border 11/layer B in fig. 4 on a side facing away from opening 12; col. 5, lines 52-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first side of the base of modified Rodriguez to include an outer seal around the superabsorbent substance, as taught by Broida, in order to keep absorbed fluid from escaping the SAP on the side facing away from the transcutaneous element and onto the skin or clothing.
Regarding claim 10, modified Rodriguez discloses the body-wearable medical device according to claim 1 comprising the first side of the base (side 162b of skin adhesive layer 162 in fig. 2).
Modified Rodriguez fails, however, to disclose that the first side of the base further comprises an inner seal on a side of the superabsorbent substance facing the transcutaneous element.
Broida teaches an inner seal (Broida: flange 23 at opening 12 in figs. 1-4, 7) on a side of the superabsorbent substance facing the transcutaneous element (Broida: flange 23 is on a side of the SAP facing opening 12; col. 7, lines 19-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first side of the adhesive base of modified Rodriguez to include an inner seal on the side of the superabsorbent substance facing the transcutaneous element, as taught by Broida, in order to confine leaked fluid to the channel path into the SAP and keep it from spreading under the adhesive next to the insertion site.
Regarding claim 13, modified Rodriguez discloses the body-wearable medical device according to claim 1, wherein each of the inner enclosure segments (first portion 420 of cut-outs 412a-d are spaced around bore hub 134/bore 144 and sit on main channel 136; fluid is channeled away from sensor assembly 102 in fig. 7; col. 13, line 42-65; Broida’s SAP can be attached at first portion 420 to absorb fluid) and outer enclosure segments (second portion 422 of cut-outs 412a-d are spaced around bore hub 134/bore 144 and extend beyond and across the respective intermediate channel 142a-142d of the first adhesive member 130; fluid is channeled away from sensor assembly 102 in fig. 7; col. 13, line 65 - col. 14, line 18; Broida’s SAP can be attached at second portion 422 to absorb fluid) is connected to at least one of the at least one fluid channel (first portion 420 is aligned with main channel 136 in fig. 7; second portion 422 is aligned with intermediate channels 142a-d in fig. 7).
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Broida and further in view of US Publication No. 2019/0083017, hereinafter “Walter”.
Regarding claim 7, modified Rodriguez discloses the body-wearable medical device according to claim 1 comprising the base (coupling system 104 with first adhesive member 130 and second adhesive member 131 in figs. 1-2).
Modified Rodriguez fails, however, to disclose that the base further comprises a septum that is configured for being pierced by the transcutaneous element during use of the body-wearable medical device.
Walter teaches a septum (Walter: septum 146 in figs. 1B-1D and 2A-2C; para [0189]) that is configured for being pierced by the transcutaneous element during use of the body-wearable medical device (Walter: septum 146 may be penetrable by the insertion cannula 144; para [0189]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of modified Rodriguez to include a septum configured to be pierced by the transcutaneous element, as taught by Walter, in order to seal the insertion opening through the adhesive base until the transcutaneous element passes through it and to limit moisture and contaminants at the insertion site.
Regarding claim 12, modified Rodriguez discloses the body-wearable medical device according to claim 1 comprising the first side of the base (side 162b of skin adhesive layer 162 in fig. 2).
Modified Rodriguez fails, however, to disclose that the first side of the base comprises plaster that carries the adhesive for attaching the body-wearable medical device to a patient's body.
Walter teaches plaster (Walter: plaster 196 in figs. 1D, 2A-2C) that carries the adhesive for attaching the body-wearable medical device to a patient's body (Walter: the adhesive surface may comprise at least one plaster or an adhesive strip; para [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive base of modified Rodriguez to include a plaster that carries the skin adhesive, as taught by Walter, in order to provide a flexible skin-facing layer that holds the adhesive for attaching the housing to the patient.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez in view of Broida and further in view of US Patent No. 10,667,955, hereinafter “Allen”.
Regarding claim 9, modified Rodriguez discloses the body-wearable medical device according to claim 8 comprising the outer seal (Broida: liquid-impermeable peripheral border 11 in fig. 4) and the base portion (side 162b of skin adhesive layer 162 in fig. 2).
Modified Rodriguez fails, however, to disclose that the outer seal comprises a silicone structure that at least partially projects away from the first side of the base portion and/or is integrated in the first side of the base, such that, during use of the body-wearable medical device, the silicone structure is in contact with the base and the skin of the user.
Allen teaches a silicone structure (Allen: silicone adhesive in fig. 34A) that at least partially projects away from the first side of the base portion and/or is integrated in the first side of the base (Allen: silicone adhesive on lower surface of contact layer 3960; col. 45, lines 51-55), such that, during use of the body-wearable medical device, the silicone structure is in contact with the base and the skin of the user (Allen: silicone adhesive on lower surface of contact layer 3960 adheres to skin of patient; col. 45, lines 51-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer seal on the first side of the adhesive base of modified Rodriguez to include a silicone structure that is integrated in and/or projects from that first side and contacts the base and the skin, as taught by Allen, in order to form a skin-facing seal around the SAP that holds fluid in the absorber and stays in contact with the plaster and the skin.
Regarding claim 11, modified Rodriguez discloses the body-wearable medical device according to claim 10, wherein the inner seal (Broida: flange 23 at opening 12 in figs. 1-4, 7) comprises a silicone structure (Allen: silicone adhesive in fig. 34A) that at least partially projects away from the first side of the base (side 162b of skin adhesive layer 162 in fig. 2) and/or is integrated in the first side of the base (Allen: silicone adhesive on lower surface of contact layer 3960; col. 45, lines 51-55), such that, during use of the body-wearable medical device, the silicone structure is in contact with the base and the skin of the user (Allen: silicone adhesive on lower surface of contact layer 3960 adheres to skin of patient; col. 45, lines 51-55).
It would have been obvious to form Broida’s inner flange 23 as the same silicone structure used for the outer seal in claim 9, so the inner seal also contacts the plaster and the skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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