Prosecution Insights
Last updated: October 04, 2026
Application No. 18/575,056

A Flexible and Stretchable Cover for Attaching a Component to a Patch

Final Rejection §103§112
Filed
Dec 28, 2023
Priority
Jul 01, 2021 — EU 21183306.6 +1 more
Examiner
CHA, CASEY GEORGE
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Datwyler Pharma Packaging Belgium NV
OA Round
2 (Final)
18%
Grant Probability
At Risk
3-4
OA Rounds
8m
Est. Remaining
-4%
With Interview

Examiner Intelligence

Grants only 18% of cases
18%
Career Allowance Rate
2 granted / 11 resolved
-51.8% vs TC avg
Minimal -22% lift
Without
With
+-22.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
18 currently pending
Career history
35
Total Applications
across all art units

Statute-Specific Performance

§101
6.0%
-34.0% vs TC avg
§103
53.0%
+13.0% vs TC avg
§102
21.5%
-18.5% vs TC avg
§112
17.5%
-22.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 11 resolved cases

Office Action

§103 §112
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 . Response to Amendment The amendment filed 05/21/2026 has been entered. Claims 1-19 remain pending in the application. Response to Arguments Applicant’s arguments with respect to claim(s) 1-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. 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 3 and 10 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. The term “optionally” in claims 3 and 10 a relative term which renders the claim indefinite. The term “optionally” 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. The claim language following optionally is rendered indefinite. 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 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. For examination purposes the phrase “and/or” will be interpreted as “or”. Claim(s) 1,4, 7, 8, 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz (Embodiment 1, US 20190175094 A1) herein referred to as “Ortiz embodiment 1” in view of Ortiz (Embodiment 2) herein referred to as “Ortiz embodiment 2”. Regarding claim 1, Ortiz embodiment 1 discloses: A flexible and stretchable cover (40) configured for attachment to a patch (10) ([Figure 8A-8B]; Ortiz embodiment 1 discloses strap or band 810 which is seen as a patch) a component (70) ([Figure 8A-8B]; Ortiz embodiment 1 discloses a component 800), whereby the cover (40) is a single- piece element, the single piece element comprising at least two flexible and stretchable clamping parts(41) arranged at opposing sides of the component (70) when mounted ([Figures 8A-8B]; elastomer bellows 820 which are seen as flexible clamping parts on either side of component 800), the clamping parts (41) being configured: to clamp the component (70) when mounted inside the cover (40) in such a way that the clamping parts(41) are in contact with the component (70) ([Figures 8A-8B]; Bellows 820 are in contact with component 800); and- to apply a compression force to the component (70) ([0045, 0046]; Ortiz embodiment 1 discloses the bellows applying a compressive force as shown by arrows 16), thereby attaching the component (70) to the inside of the cover (40). Ortiz embodiment 1 does not explicitly discloses: A flexible and stretchable cover (40) configured for attachment to a patch (10) and at least partially enclosing a component (70), whereby the cover (40) is a single- piece element, the single piece element comprising at least two flexible and stretchable clamping parts(41) thereby attaching the component (70) to the inside of the cover (40). However, Ortiz embodiment 2 discloses: A flexible and stretchable cover (40) ([0040, Figure 4]; Ortiz discloses flexible strap 492 which is seen as a stretchable cover), whereby the cover (40) is a single- piece element, the single piece element comprising ([0040, Figure 4]; The strap 492 is a single piece element) Clamps attaching the component (70) to the inside of the cover (40). ([Ortiz embodiment 1, Figures 8A-8B]; Ortiz discloses bellows attaching the component 800 to strap or band 810, [Ortiz embodiment 2, 0040]; Ortiz discloses strap 492 enclosing bio sensing component. Enclosing Ortiz embodiment 1 with the strap of Ortiz embodiment 2 bellows 820 [Ortiz embodiment 1, Figures 8A-8B] would secure components 800 [Ortiz embodiment 1, Figures 8A-8B] to strap 492 [Ortiz embodiment 2, 0040]. It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch sensor as disclosed by Ortiz embodiment 1 with the enclosing strap as disclosed by Ortiz embodiment 2. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Regarding claim 4, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover (40) of claim 1. Ortiz embodiment 1 further discloses: wherein: - the at least two clamping parts (41) are configured to apply the compression force to the component (70) ([Figures 8A-8B]; Ortiz embodiment 1 discloses bellows 820 applying a compressive force), according to at least one of: - along at least one direction ([Figures 8A-8B]; The force is along one direction as shown by arrows 16). The phrase “and/or” is seen as non-limiting and accordingly not a necessary for the claimed invention. and/or - along a plurality of directions; and/or - inwards along at least a part of an outer surface of the component (70); Regarding claim 7, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: A cover assembly configured for attachment to a patch (10), wherein the cover assembly comprises the cover (40) of claim 1. Ortiz embodiment 1 disclose: The component (70) ([Figures 8A-8B]; Ortiz discloses device 800 which is seen as a component) and at least two flexible and stretchable clamping parts(41). ([Figures 8A-8B]; Ortiz discloses flexible bellows 829, which are seen as clamps). Ortiz embodiment 1 does not explicitly disclose: the cover (40) However, Ortiz embodiment 2 discloses: the cover (40) ([Figure 4]; Ortiz discloses strap 492, which is seen as a cover). Enclosing the component and clamping parts as disclosed by Ortiz embodiment 1 with the cover as disclosed by Ortiz embodiment 2 would disclose: and the component (70) mounted inside the cover (40) by means of the at least two flexible and stretchable clamping parts(41). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch sensor as disclosed by Ortiz embodiment 1 with the enclosing strap as disclosed by Ortiz embodiment 2. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Regarding claim 8, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover assembly of claim 7. Ortiz embodiment 2 further discloses: wherein the cover (40)([Figure 4] strap 492 which is seen as a cover): - is in direct contact with the component (70) over at least part of its interior surface ([Figure 4]; Strap 492 is in direct contact with device 400 which is seen as a component); and/or - is provided with one or more inward projections (47) that are in direct contact with the component (70), wherein optionally the inward projections (47) are dimensioned to increase stretchability and/or flexibility at the location of direct contact with the clamping part(41). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch sensor as disclosed by Ortiz embodiment 1 with the enclosing strap as disclosed by Ortiz embodiment 2. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Regarding claim 9, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover assembly of claim 7. Ortiz embodiment 2 further discloses: wherein the at least two flexible and stretchable clamping parts(41) are configured such that, when subjected to changes resulting from flexing and/or stretching of the cover (40), the material of the clamping parts (41) in contact with the component (70) is slidable with respect to the component (70). ([0045]; Ortiz embodiment 2 discloses flexible collar 720 that allows motion between the device and the collar, which is seen as slidable with respect to the component) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch sensor as disclosed by Ortiz embodiment 1 with the enclosing strap as disclosed by Ortiz embodiment 2. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Regarding claim 16, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover assembly of claim 7. The phrase “and/or” is seen as non-limiting language and accordingly not necessary for the claimed invention. Ortiz embodiment 1 further discloses: wherein the at least two flexible and stretchable clamping parts(41): are in direct contact with the component (70) over at least part of its interior surface; ([Figures 8A-8B]; Ortiz embodiment 1 discloses bellows 820, which are seen as flexible and stretchable clamping parts in direct contact with device 800 which is seen as a component) and/or- are provided with one or more inward projections (47) that are in direct contact with the component (70), wherein optionally the inward projections (47) are dimensioned to increase stretchability and/or flexibility at the location of direct contact with the clamping parts (41). Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Ortiz embodiment 2 further in view of Ortiz (embodiment 3) herein referred to as “Ortiz embodiment 3” Regarding claim 2, Ortiz embodiment 1 in view of Ortiz embodiment 2 discloses: The cover of claim 1. Ortiz embodiment 1 disclose: clamping parts (41) are configured to clamp the component (70) ([Figures 8A-8B]; Ortiz discloses bellow 820 , which are seen as clamp components, and device 800, which is seen as the component). Ortiz embodiment 1 does not explicitly disclose: the cover (40) and clamping parts (41) that are in slidable contact with the component (70). However, Ortiz embodiment 2 discloses: the cover (40) ([0040, Figure 4]; Ortiz embodiment 2 discloses flexible strap 492 which is seen as a stretchable cover). Further Ortiz embodiment 3 discloses: clamping parts (41) that are in slidable contact with the component (70). ([0045]; Ortiz embodiment 3 discloses flexible collar 720, which is seen as clamps, and device 700, which is seen as the component, and movement therebetween, which is seen as being in slidable contact with the component). Enclosing the device as disclosed by Ortiz embodiment 1 with the strap as disclosed by Ortiz embodiment 2 further allowing for movement between the clamps and device as disclosed by Ortiz embodiment 3 discloses: wherein the clamping parts (41) are configured to clamp the component (70) when mounted inside the cover (40) in such a way that the clamping parts (41) are in slidable contact with the component (70). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cover as disclosed by Ortiz embodiment 1 in view of Ortiz embodiment 2 with the enclosing strap as further disclosed by Ortiz embodiment 2 and the slidable contact as disclosed by Ortiz embodiment 3. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Claim(s) 3, 11, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Ortiz embodiment 2 further in view of Heikenfeld (US 20180340903 A1) herein referred to as “Heikenfeld”. Regarding claim 3, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover (40) of claim 1. Ortiz embodiment 1 discloses: and - the patch (10) is configured for attachment to skin of a subject. Ortiz embodiment 1 does not explicitly disclose: wherein: - the cover (40) is configured for attachment at one or more attachment points (44) to the patch (10); “and optionally’ is seen as non-limiting language and accordingly not necessary for the claimed invention - and optionally, the cover (40) is configured as a separate and/or different element from the patch (10); - and optionally, the cover (40) is not configured for attachment to skin of the subject; - and optionally, only the cover (40) is configured to clamp the component (70) when mounted inside the cover (40); - and optionally, only the cover (40) is configured to apply the compression force to the component (70); - and optionally, the patch (10) is configured not to clamp the component (70) when mounted inside the cover (40); - and optionally, the patch (10) is configured not to apply the compression force to the component (70) when mounted inside the cover (40); - and optionally, the patch (10) is configured not to contact the component (70) when mounted inside the cover (40). However, Heikenfeld discloses: wherein: - the cover (40) is configured for attachment at one or more attachment points (44) to the patch (10) ([Figure 1]; Heikenfeld discloses cover 290 that is attached to adhesive 210, which is seen as a patch, at two points) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cover as disclosed by Ortiz embodiment 1 in view of Ortiz embodiment 2 with the attachment to the patch as disclosed by Heikenfeld. The motivation being to enclosed electrical components and protect against outside electromagnetic interference ([0030]). Regarding claim 11, Ortiz embodiment 1 in view of Heikenfeld disclose: The patch assembly (1) of claim 10. Ortiz embodiment 1 further discloses: a gap between the component (70) and the patch (10). ([Figures 8A-8B]; Ortiz embodiment one discloses a gaps between the sides of device 800 and the strap 810, which is seen as the patch) Ortiz embodiment 1 does not explicitly disclose: wherein the cover (40) comprises a proximal or inferior portion (45) configured to at least partially cover the side of the component (70) which is closest to the patch (10) of the patch assembly (1), and wherein the proximal or inferior portion (45) of the cover (40) defines a gap between the component (70) and the patch (10). However, Ortiz embodiment 2 discloses: wherein the cover (40) comprises a proximal or inferior portion (45) configured to at least partially cover the side of the component (70) which is closest to the patch (10) of the patch assembly (1),) ([Figure 4]; Ortiz embodiment 2 discloses strap 492 which is seen as a cover. And the cover has a proximal portion, facing away from the device 400 and an inferior portion facing the device 400.) and wherein the proximal or inferior portion (45) of the cover (40) defines a gap between the component (70) and the patch (10). ([Figure 4]; gap 490 between component 414 and patch 410). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch sensor as disclosed by Ortiz embodiment 1 with the enclosing strap as disclosed by Ortiz embodiment 2. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Regarding claim 15, Ortiz embodiment 1 and Ortiz embodiment 2 in view of Heikenfeld disclose: the patch assembly of claim 10 . Heikenfeld further discloses: A method for measurement of a physiological status of a subject, the method comprising placing the patch assembly of claim 10 in contact with subject such that the patch (10) is positioned to measure the physiological status; and measuring the physiological status. ([Figure 2]; Heikenfeld discloses a patch attached to a subject’s skin, [0024]; Heikenfeld discloses the device “that measures sweat, sweat generation rate, sweat chronological assurance, its solutes, solutes that transfer into sweat from skin, a property of or things on the surface of skin, or properties or things beneath the skin”, which is seen as measuring the physiological status.) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch as disclosed by Ortiz embodiment 1 in view of Heikenfeld with the contact and monitoring as further disclosed by Heikenfeld. The motivation being to sample sweat based parameters directly from the skin ([0024]). Regarding claim 18, Ortiz embodiment 1 in view of Heikenfeld further in view of Shoendorfer disclose: The patch assembly (1) of claim 13. Ortiz embodiment 1 in view of Heikenfeld do not explicitly disclose: wherein the membrane (50) is impermeable to fluid. However, Ortiz embodiment 2 discloses: wherein the membrane (50) is impermeable to fluid. ([0040]; Ortiz embodiment 2 discloses a sweat impermeable layer 418, which is seen as a membrane) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch sensor as disclosed by Ortiz embodiment 1 in view of Heikenfeld with the enclosing strap as disclosed by Ortiz embodiment 2. The motivation being Ortiz states that embodiment features may be used in combination ([0051]). Claim(s) 5, 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Ortiz embodiment 2 further in view of Mazar et. al. (US 20110144470 A1) herein referred to as “Mazar” Regarding claim 5, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover (40) of claim 1. The term “defined by at least one of the following parameters” is seen as requiring only one of the listed features for the claimed invention. Ortiz embodiment 1 does not explicitly disclose: wherein the cover consists of a material defined by at least one of the following parameters: - a hardness in the range of at least 10 shore A to at most 90 shore A ; - a tensile strength in the range of at least 5.0 N/mm2 to at most 11.0 N/mm; - a maximal elongation in the range of at least 100% to at most 800%; and/or - a tear strength in the range of at least 20 to at most 30 N/mm; . However, Mazar discloses: wherein the cover consists of a material defined by at least one of the following parameters: - a hardness in the range of at least 10 shore A to at most 90 shore A ([0051]; Mazar discloses cover 213 being made of silicone which can have a shore hardness of 10A-90A.); - a tensile strength in the range of at least 5.0 N/mm2 to at most 11.0 N/mm([0051]; Mazar discloses cover 213 being made of silicone which can have a tensile strength of 2.4 to 11 N/mm^2)- a maximal elongation in the range of at least 100% to at most 800%; and/or - a tear strength in the range of at least 20 to at most 30 N/mm; . It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cover as disclosed by Ortiz embodiment 1 in view of Ortiz embodiment 2 with the material as disclosed by Mazar. The motivation being to include a biocompatible material ([0051]). Regarding claim 6, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover (40) of claim 1. Ortiz embodiment 1 in view of Ortiz embodiment 2 do not explicitly disclose: wherein the cover comprises silicone rubber (SR), liquid silicone rubber (LSR); a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic polyamide (TPA); a thermoplastic vulcanizate (TPV), a cross-linkable elastomer, isoprene rubber (IR), nitrile rubber (NBR), styrene- butadiene rubber (SBR), Ethlylene Propylene Diene Monomer (EPDM), fluorocarbon-based fluoroelastomer materials (FKM), polybutadiene rubber (BR); and/or combinations thereof. However, Mazar discloses: wherein the cover comprises silicone rubber (SR), liquid silicone rubber (LSR); a thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic polyamide (TPA); a thermoplastic vulcanizate (TPV), a cross-linkable elastomer, isoprene rubber (IR), nitrile rubber (NBR), styrene- butadiene rubber (SBR), Ethlylene Propylene Diene Monomer (EPDM), fluorocarbon-based fluoroelastomer materials (FKM), polybutadiene rubber (BR); and/or combinations thereof. ([0051]; Mazar discloses cover 213 being made of silicone which can have a shore hardness of 10A-90A.) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cover as disclosed by Ortiz embodiment 1 in view of Ortiz embodiment 2 with the material as disclosed by Mazar. The motivation being to include a biocompatible material ([0051]). Regarding claim 14, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover (40) of claim 1. Ortiz embodiment 1 in view of Ortiz embodiment 2 do not explicitly discloses: A method for the attachment of a component (70) to a patch (10), the method comprising: attaching the component (70) to the patch (10) via a cover (40). However, Mazar discloses: A method for the attachment of a component (70) to a patch (10), the method comprising: attaching the component (70) to the patch (10) via a cover (40). ([Figure 2B]; Mazar discloses cover 203 enclosing component 207A-207D and attaching to patch 202) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cover as disclosed by Ortiz embodiment 1 in view of Ortiz embodiment 2. The motivation being to retain the components ([0049]). Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Heikenfeld. Regarding claim 10, Ortiz embodiment 1 discloses: A patch assembly (1) configured for attachment to a subject's skin ([Figures 8A-8B]; Ortiz discloses strap 810, which is seen as a patch) comprising: - at least one cover assembly of - at least one cover assembly of - a patch (10) configured for removeable attachment to the skin of a subject ([0046]; Ortiz embodiment 1 discloses the strap being removable). The term “and optionally” is seen as non-limiting language and accordingly not necessary for the claimed invention. and optionally wherein the component (70) comprises and/or consists of one or more of the following: - an electronic component; - a non-electronic component; - a reservoir; and/or - a dispenser. Ortiz embodiment 1 does not explicitly disclose: whereby the at least one cover assembly is attached to the patch (10) via the cover (40) of the cover assembly, However, Heikenfeld discloses: whereby the at least one cover assembly is attached to the patch (10) via the cover (40) of the cover assembly ([Figure 1]; Heikenfeld discloses cover 290 that is attached to adhesive 210, which is seen as a patch, at two points) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the cover as disclosed by Ortiz embodiment 1 with the attachment to the patch as disclosed by Heikenfeld. The motivation being to enclosed electrical components and protect against outside electromagnetic interference ([0030]). Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Heikenfeld further in view of Mazar. Regarding claim 12, Ortiz embodiment 1 in view of Heikenfeld disclose: The patch assembly (1) of claim 10. Ortiz embodiment 1 in view of Heikenfeld do not explicitly disclose: wherein the patch assembly (1) further comprises: - a sensor configured for measurement of a physiological status in electronic communication with the component (70), wherein the component (70) comprises at least one electronic circuit configured to process, store, and or communicate the measurement of the sensor. However, Mazar discloses: wherein the patch assembly (1) further comprises: - a sensor configured for measurement of a physiological status in electronic communication with the component (70), wherein the component (70) ([Figure 2B]; Electrodes 207A-207D, which are seen as sensors in cominication with component 203) comprises at least one electronic circuit configured to process, store, and or communicate the measurement of the sensor. ([0070]; Mazar discloses electrodes connected to a circuit with memory, processor and wireless communication, which is seen as processing, storing and communicating sensor data) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch assembly as disclosed by Ortiz in view of Heikenfeld with the electrode circuitry as disclosed by Mazar. The motivation being to contain electronic components and record physiological signals from the subject ([0011]). Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Heikenfeld further in view of Schoendorfer (US 5441048 A) herein referred to as “Schoendorfer”. Regarding claim 13, Ortiz embodiment 1 in view of Heikenfeld disclose: The patch assembly (1) of claim 10. Ortiz embodiment 1 in view of Heikenfeld do not explicitly disclose disclose: further comprising a membrane (50) which is permeable to gas. However, Shoendorfer discloses: further comprising a membrane (50) which is permeable to gas ((5); Sheondorfer discloses gas permeable layer 16 which is seen as a membrane) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch assembly as disclosed by Ortiz embodiment 1 in view of Heikenfeld. The motivation being to allow volatized liquid to pass ((7)) Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Heikenfeld further in view of Baxi et. el. (US 20180084643 A1) herein referred to as “Baxi”. Regarding claim 17, Ortiz embodiment 1 in view of Ortiz embodiment 2 further in view of Heikenfeld disclose: The patch assembly (1) of claim 11. Ortiz embodiment 1 further discloses: one pair of clamping parts (41) arranged at opposing sides of the component (70) ([Figures 8A-8B]; Ortiz embodiment 1 discloses bellows 820 on opposite sides of device 800), whereby, each of such a pair of clamping parts (41) comprises the inferior portion (45) or a part thereof, which is arranged between the component (70) and the patch (10). ([Figures 8A-8B]; Ortiz embodiment 1 discloses bellows with an inferior portion of the bellows between the patch 810 and device 800). Ortiz embodiment 1 does not explicitly disclose: wherein the cover (40) comprises at least one pair of clamping parts (41) However, Baxi discloses: wherein the cover (40) comprises at least one pair of clamping parts (41) ([Figure 4]; Baxi discloses Connecter 411 which is seen as a cover with two locking pins which are seen as clamping parts.) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch assembly as disclosed by Ortiz embodiment 1 in view of Heikenfeld with the cover as disclosed by Baxi. The motivation being to simplify the removal and replacement of the retained device ([0022]). Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz embodiment 1 in view of Ortiz embodiment 2 further in view of Baxi. Regarding claim 19, Ortiz embodiment 1 in view of Ortiz embodiment 2 disclose: The cover (40) of claim 1. Ortiz embodiment 1 further discloses: wherein the at least two flexible and stretchable clamping parts (41) are arranged in such a way that the at least two flexible and stretchable clamping parts (41) cooperate to apply the compression force to attach the component (70) ([Figure 8A-8B]; Ortiz embodiment 1 discloses bellows, which are seen as flexible and stretchable clamping parts, applying a compressive force to attach device 800, which is seen as a component). Ortiz embodiment 1 does not explicitly disclose: to attach the component (70) to the inside of the cover (40) between the at least two flexible and stretchable clamping parts (41). However, Baxi discloses: to attach the component (70) to the inside of the cover (40) between the at least two flexible and stretchable clamping parts (41). ([Figure 4]: Baxi discloses Connector 411, which is seen as a cover, with two connector pins 412, which are seen as clamping parts, connecting the component 408) It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the patch assembly as disclosed by Ortiz embodiment 1 in view of Heikenfeld with the cover as disclosed by Baxi. The motivation being to simplify the removal and replacement of the retained device ([0022]). Conclusion THIS ACTION IS MADE FINAL. 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 CASEY GEORGE CHA whose telephone number is (571)272-0749. The examiner can normally be reached Monday-Friday 8:30-5:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CASEY GEORGE CHA/Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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Prosecution Timeline

Dec 28, 2023
Application Filed
Dec 28, 2023
Response after Non-Final Action
Feb 24, 2026
Non-Final Rejection mailed — §103, §112
May 21, 2026
Response Filed
Aug 20, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
18%
Grant Probability
-4%
With Interview (-22.2%)
3y 5m (~8m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 11 resolved cases by this examiner. Grant probability derived from career allowance rate.

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