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 .
Status of Claims
Applicant' s arguments, filed 09/02/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 09/02/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant has newly added claims 206 and 207 in the response filed on 09/02/2025, which have been acknowledged and entered.
Claims 131-145 and 206-207 are the current claims hereby under examination.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 09/02/2025 is in compliance with the provision of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 131-137, 140 and 142-144 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US Patent Pub. No. 20190076069 – previously cited) hereinafter Lin.
Regarding Claim 131, Lin discloses an on-skin wearable medical device system (CGM 100 [0027]; biosensor 400 [0038]; biosensor 500 [0040]; fig 1A, 4B, 5B) comprising:
a housing (which has a housing 110 [0027]; biosensor housing 850 [0051]; housing 930 [0057]; housing 1030 [0062]; housing 1210 [0068]; housing 1310 [0071]; fig 1A, 8B, 9B, 10B, 12A, 12B, 13A, 13B);
a transcutaneous analyte sensor coupled to the housing (sensor wire 120 extends out of the housing 110 [0027]);
an insertion element configured to insert the transcutaneous analyte sensor into skin of a host and be retracted from the skin of the host following insertion of the transcutaneous analyte sensor into the skin of the host (When the wearer applies the CGM, she will puncture her skin using the insertion needle and the sensor wire will follow the needle into the puncture. After the CGM sensor wire has been inserted into the puncture and the CGM is attached to the wearer's skin the wearer retracts the needle, leaving the sensor wire under the skin and the CGM in place. [0026]; insertion needle 130 [0029]; insertion needle 320 [0036]; insertion needle 430 [0038]; insertion needle 530 [0040]; insertion needle 1120 [0066]; insertion needle 1220 [0069]; insertion needle 1320 [0071]; insertion needle 1420 [0073]; figs 1, 3, 4B, 5B, 11-14);
and a patch coupled to the housing and including a first surface for engaging skin, the patch including a puncture layer (retention feature 140 [0031]; retention feature 310 [0036]; retention feature 420 [0038]; retention feature 520 [0040]; a retention feature 610 [0043]; retention feature 722 [0049]; retention feature 854 [0051]; retention feature 1244 [0068]; The retention feature 210 also includes an extendable portion 230 that may be extended during manufacturing, or when an insertion needle is inserted through the CGM, to form a spiral shaped feature to retain a co-axial alignment between a sensor wire and insertion needle. [0033]; fig 1E, 2B, 3, 4, 5, 6, 7, 8B, 12), and wherein the transcutaneous analyte sensor and the insertion element both pass through the puncture layer prior to retraction of the insertion element with a portion of the puncture layer that is in contact with the insertion element being co-planar with a remainder of the puncture layer and with the patch (the bottom surface of the CGM 100 with an attached sensor alignment and retention feature 140 (or “retention feature”)… the retention feature has an extendible portion 142 that has been cut and spirals upwards around the insertion needle 130… tip of the cut portion 142 contains a close fitting hole which fits around and engages with the needle 130 [0031]; Examiner notes the insertion needle contains a transcutaneous analyte sensor and fig 1E shows the insertion need and the sensor passing through the puncture layer prior to retraction of the insertion element. Examiner notes that prior to retraction and insertion, extendible portion 142 is in contact with the insertion element 130 and is co-planar with a remainder of the retention feature 140 and bottom of surface of the CGM 100; the retention feature 520 is coupled to a pad 510 that may be affixed during manufacturing to a lower surface of a biosensor…the retention feature 520 in this example has a central feature 524 that engages with and encircles the insertion needle 530 of a biosensor 500… the opening may be created when an insertion needle is inserted through the CGM and retention feature, which may occur during the manufacturing process or at the time the CGM is applied by the wearer. [0040]; each leg 522a-b has two ends, one of which is coupled to a pad 510 [0041]; the legs 522a-b allow the central feature 520 to collapse against the bottom surface of the biosensor 500 when it is applied to a wearer's skin [0042]; figs 5A-5B; Examiner notes element 420 in fig 5A should read 520. Examiner notes that prior to retraction and insertion, the central feature 524 of the retention feature 520 is in contact with the insertion needle 530 and is co-planar with the remainder of the retention feature 520 and pad 510), and the puncture layer stabilizes the transcutaneous analyte sensor relative to the insertion element (the extendible portion 142 helps maintain co-axial alignment between the sensor wire 120 and insertion needle 130 [0031]; fig 1E; this example retention feature 520 provides alignment and retention of a sensor wire within a hollow insertion needle 530 used to apply an invasive biosensor 500. [0042]; figs 5A-5B).
Regarding Claim 132, Lin discloses the invention as discussed above in claim 131. Lin further discloses the puncture layer is configured to retain the transcutaneous analyte sensor in a channel of the insertion element (the retention feature (140) has an extendible portion 142… thereby helping to prevent the sensor wire 120 from dislodging from within the cross-section of the hollow insertion needle 130 [0031]; fig 1E; Examiner notes that retention features 420, 520, 610 also have an extendible portion).
Regarding Claim 133, Lin discloses the invention as discussed above in claim 131. Lin further discloses the portion of the puncture layer that is in contact with the insertion element is configured to form a seal about the insertion element to retain the transcutaneous analyte sensor in a channel of the insertion element (The tip of the cut portion 142 contains a close fitting hole which fits around and engages with the needle 130, thereby helping to prevent the sensor wire 120 from dislodging from within the cross-section of the hollow insertion needle 130. [0031]; fig 1E; Examiner notes that retention features 420, 520, 610 also have an extendible portion).
Regarding Claim 134, Lin discloses the invention as discussed above in claim 131. Lin further discloses the puncture layer is configured to stabilize the transcutaneous analyte sensor from dislodging from a channel of the insertion element in a horizontal dimension (extendible portion 142 helps maintain co-axial alignment between the sensor wire 120 and insertion needle 130 [0031]; Examiner notes that maintaining co-axial alignment would stabilize the sensor wire from dislodging from the insertion needle in a horizontal dimension and that retention feature 610 functions in the same manner).
Regarding Claim 135, Lin discloses the invention as discussed above in claim 131. Lin further discloses wherein the patch includes a plurality of layers (a pad may be formed from multiple layers coupled to each other [0034]) and the puncture layer (retention feature 610 [0043]) is a first layer of the plurality of layers layered adjacent to a second layer (a backing material 630 [0043]) of the plurality of layers (Examiner notes fig 6 shows the puncture layer 610 adjacent to a second layer 630).
Regarding Claim 136, Lin discloses the invention as discussed above in claim 135. Lin further discloses the second layer includes the first surface (bottom-layer adhesive 640 is a PSA that is applied to the backing material 630 [0046]; fig 6), and the first layer is sandwiched between the second layer and the housing (The PSA is applied to the perimeter of the retention feature 610 and is also applied to portions of the backing material 630 to provide adhesion between the backing material 630 and the bottom surface of a biosensor housing. [0044]; Examiner notes that the housing would be above the first layer 610 in fig 6).
Regarding Claim 137, Lin discloses the invention as discussed above in claim 135. Lin further discloses the plurality of layers includes a third layer (top-layer adhesive 620 [0044]) sandwiched between the first layer and the second layer, the third layer including an adhesive surface for adhering the patch to the housing (the top-layer adhesive 620 may be applied at any suitable locations on the backing material 630 to provide adhesion between the backing material 630 and the retention feature 610, as well as between the backing material 630 and the bottom surface of a biosensor housing [0044]; fig 6).
Regarding Claim 140, Lin discloses the invention as discussed above in claim 131. Lin further discloses the housing includes a cavity for receiving a portion of the transcutaneous analyte sensor; and at least a portion of the puncture layer extends along the cavity (retention feature 854 is applied at a location corresponding to where a sensor wire and needle extend (or will extend) from the bottom surface of the housing 850, such that an opening on the retention feature 934 are aligned with the exit point of the sensor wire from the bottom surface of the housing 850 [0052]; Examiner notes that retention feature 610 functions in the same manner as retention feature 854).
Regarding Claim 142, Lin discloses the invention as discussed above in claim 131. Lin further discloses the puncture layer is made of a hydrophobic material (retention feature 210 in this example includes a pad (or backing material) 220 [0033]; the pad 220 is formed of a polyurethane foam [0034]; Examiner notes the composition of retention feature 610 is the same as retention feature 210).
Regarding Claim 143, Lin discloses the invention as discussed above in claim 131. Lin further discloses the puncture layer is configured for the insertion element to retract through the puncture layer with the transcutaneous analyte sensor remaining passing through the puncture layer (the insertion 1220 needle has been withdrawn. The retention feature 1244 has been forced upward into contact with the pad 1242, and the sensor wire 1230 has been left in place within the wearer's skin. [0070]; fig 12b; Examiner notes that retention feature 1244 functions the same way as retention feature 610).
Regarding Claim 144, Lin discloses the invention as discussed above in claim 131. Lin further discloses the first surface comprises an adhesive surface (the bottom-layer adhesive 640 comprises an adhesive suitable for long-term contact with a person's skin [0046]; fig 6).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 138-139 and 206 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US Patent Pub. No. 20190076069 – previously cited), as applied to claim 135 above.
Regarding Claim 138, Lin discloses the invention as discussed above in claim 135. Lin further discloses the first layer includes a puncture portion (the retention feature has an extendible portion 142 [0031]; retention feature 420 in this example has a central feature 424 [0038]; fig 1E, 4A) and a support portion (retention feature 140, in this example, includes a portion adhered to the bottom surface of the CGM 100 [0031]; retention feature 420 is coupled to a pad 410 that may be affixed to a lower surface of a biosensor, such as biosensor 400 [0038]; fig 1E, 4B), the puncture portion including the portion of the puncture layer that is in contact with the insertion element, (tip of the cut portion 142 contains a close fitting hole which fits around and engages with the needle 130 [0031]; retention feature 420 in this example has a central feature 424 that engages with and encircles the insertion needle 430 of a biosensor 400 [0038]; fig 1E, 4A), the support portion being positioned radially outward from the puncture portion and configured to overlap another layer of the plurality of layers (fig 1E, 4A, 4B, 6; Examiner notes that the portion/pad 410 adhered to the bottom surface of the CGM 100 is positioned radially outward from the extendable portion 142/central feature 424 and configured to overlap another layer of the plurality of layers). Lin also discloses “any particular feature, structure, operation, or other characteristic described in this specification in relation to one example or implementation may be combined with other features, structures, operations, or other characteristics described in respect of any other example or implementation” [0089].
It would have been obvious to a person having ordinary skill in the art at the time of the effective filing date to have swapped the retention feature 610 for retention feature 140 or retention feature 420. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claim 139, Lin discloses the invention as discussed above in claim 138. Lin further discloses the support portion comprises an elongate arm extending radially outward from the puncture portion (In addition to the central feature 424, the example retention feature 420 includes two legs 422a-b. [0039]; Examiner notes fig 4A shows the two legs 422a-b extending radially outward from the puncture portion 424).
Regarding Claim 206, Lin discloses the invention as discussed above in claim 131. Lin further discloses the patch includes a plurality of layers (a pad may be formed from multiple layers coupled to each other [0034]), and the remainder of the puncture layer includes a support portion that overlaps another layer of the plurality of layers (the assembly has a retention feature 722 formed from the same piece of material as the backing material 720 [0049]; fig 7). Lin also discloses “any particular feature, structure, operation, or other characteristic described in this specification in relation to one example or implementation may be combined with other features, structures, operations, or other characteristics described in respect of any other example or implementation” [0089].
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the wearable medical device of Lin such that the retention feature 140 is swapped for the retention feature 722. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim(s) 141, 145, and 207 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US Patent Pub. No. 20190076069 – previously cited), as applied to claim 131 above, in view of Lee et al. (US Patent Pub. No. 20160058380 – cited by Applicant and previously cited) hereinafter Lee.
Regarding Claim 141, Lin discloses the invention as discussed above in claim 131. Lin fails to disclose the puncture layer includes at least one elongate arm for forming at least one passageway for moisture transport. However, Lee teaches a puncture layer includes at least one elongate arm for forming at least one passageway for moisture transport (adhesive pad 550 further includes a plurality of channels 552… The pattern of channels 552 may be selected to provide a desired moisture channeling behavior. [0255]; fig 33). Lee also teaches the negative effects of moisture retention (Moisture buildup between the wearer's skin and the adhesive pad over-hydrates (macerates) the skin, causing the outer skin layer(s) to shed faster than normal. When the outer layer of the skin sheds, the adhesive pad tends to become detached from the wearer. This premature peel-off of an adhesive pad can be problematic even before the adhesive pad completely detaches from the skin. [0131]).
Lin and Lee are considered analogous art because both inventions are directed towards the same field of endeavor.
It would have been obvious to a person having ordinary skill in the art at the time of the effective filing date to have modified the puncture layer of Lin such that it included at least one elongate arm for forming at least one passageway for moisture transport as taught by Lee because it would improve the CGM function and lifespan. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 145, Lin discloses the invention as discussed above in claim 131. Lin fails to disclose the system further comprising an applicator housing configured to retain the housing. However, Lee teaches an applicator housing configured to retain a housing (adhesive sensor system 200 including a sensor electronics unit 202 secured to an adhesive pad 204 and a replaceable reinforcing overlay 206. With reference to FIG. 2, the sensor electronics unit 202 is received within an electronics housing 208 [0155]; an applicator device 570 for an adhesive pad of an adhesive sensor system [0260]; fig 35).
It would have been obvious to a person having ordinary skill in the art at the time of the effective filing date to have modified the wearable medical device of Lin such that it included an applicator housing configured to retain a housing as taught by Lee. It is well-known, routine, and conventional activity in the art to have an applicator housing configured to retain a housing of an on-skin wearable device to attach the wearable device to the skin of a user. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 207, Lin discloses the invention as discussed above in claim 131. Lin further discloses the patch includes a plurality of layers (a pad may be formed from multiple layers coupled to each other [0034]), and the remainder of the puncture layer overlaps and is adhered to another layer of the plurality of layers (the assembly has a retention feature 722 formed from the same piece of material as the backing material 720… A top-layer adhesive 710 may then be applied to one side of the backing material 720 to adhere the backing material to a bottom surface of an invasive biosensor. A bottom-layer adhesive 730 may be applied to the other side of the backing material 720 to adhere the backing material 720 to a wearer's skin. [0049]; fig 7). Lin also discloses “any particular feature, structure, operation, or other characteristic described in this specification in relation to one example or implementation may be combined with other features, structures, operations, or other characteristics described in respect of any other example or implementation” [0089]. Lin fails to disclose the remainder of the puncture layer includes an elongate arm overlapping and adhered to another layer of the plurality of layers.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the wearable medical device of Lin such that the retention feature 140 is swapped for the retention feature 722. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
The modified wearable medical device of Lin fails to teach the remainder of the puncture layer includes an elongate arm overlapping and adhered to another layer of the plurality of layers.
However, Lee teaches a puncture layer includes at least one elongate arm for forming at least one passageway for moisture transport (adhesive pad 550 further includes a plurality of channels 552… The pattern of channels 552 may be selected to provide a desired moisture channeling behavior. [0255]; fig 33). Lee also teaches the negative effects of moisture retention (Moisture buildup between the wearer's skin and the adhesive pad over-hydrates (macerates) the skin, causing the outer skin layer(s) to shed faster than normal. When the outer layer of the skin sheds, the adhesive pad tends to become detached from the wearer. This premature peel-off of an adhesive pad can be problematic even before the adhesive pad completely detaches from the skin. [0131]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the wearable medical device of Lin such that the remainder of the puncture layer includes an elongate arm, as taught by Lee, because it can be used to channel moisture away and prevent moisture buildup. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
The wearable medical device of Lin in view of Lee teaches the remainder of the puncture layer includes an elongate arm overlapping and adhered to another layer of the plurality of layers.
Response to Arguments
Applicant’s arguments, see pages 5-6 of Remarks, filed 09/02/2025, with respect to the 35 U.S.C. 102 and 103 rejections have been considered but are moot in view of the new prior art rejections applied as necessitated by the amendments. Examiner notes that neither the specification nor the drawings show a separate puncture layer that is coplanar with a separate layer of the patch. Figure 39C shows puncture layer 1920 underneath patch 1900. However, because the entirety of the puncture layer is coplanar with itself and the patch includes the puncture layer, the puncture layer can be considered coplanar with the patch.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791