DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/28 is being considered by the examiner.
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 .
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.
Claim(s) 1-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Libbus et al. (US 8823490 B2) herein referred to as “Libbus” in view of Mazar et al. (US 20110144470 A1) herein referred to as “Mazar”
Regarding claim 1, Libbus discloses: A flexible and stretchable cover (40) configured for attachment to a patch (10)([(132)]; “ In some embodiments, the breathable cover may comprise a breathable water resistant cover. In some embodiments, the breathable fabric may comprise polyester, nylon, polyamide, and/or elastane (Spandex) to allow the breathable fabric to stretch with body movement.”) and at least partially enclosing a component (70) ([Figure 1I-J]; Libbus discloses a cover 162 that is attached to patch 110 and enclosing electronic 130 and 120) , Libbus does not disclose: whereby the cover (40) comprises at least one flexible and stretchable clamping part (41) which is configured: - to clamp the component (70) when mounted inside the cover (40) in such a way that the clamping part (41) is in contact with the component (70); and - to apply a compression force to the component (70), thereby attaching the component (70) to the inside of the cover (40).
However, Mazar discloses: whereby the cover (40) comprises at least one flexible and stretchable clamping part (41) ([Figure 2B]; Mazar discloses layer 203 which is seen as clamping part) which is configured: - to clamp the component (70) when mounted inside the cover (40) ([Figure 2B]; 216 is seen as the cover) in such a way that the clamping part (41) is in contact with the component (70)([Figure 2B]; 203 clamps components 207 and 214 to patch 202); and to apply a compression force to the component (70), thereby attaching the component (70) to the inside of the cover (40). ([0049]; “Covering layer 203 is also stretchable, and is positioned above and adhered to base layer 202” the cover 203 being stretchable and adhered to layer 202 with components 207 and 214 between the layers is seen as layer 203 providing compressive force on the components 207 and 214)
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 flexible cover as disclosed by Libbus in view of Mazar with the stretchable clamping part as further disclosed by Mazar the motivation being to retain circuitry ([0057])
Regarding claim 2, Libbus in view of Mazar disclose: The cover of claim 1. Libbus further discloses: clamping part (41) is in slidable contact with the component (70). ([(133)]; “Electronics housing 160 can be smooth and allow breathable cover 162 to slide over electronics housing 160, such that motion and/or stretching of cover 162 is slidably coupled with housing 160.”. Libbus does not disclose: wherein the clamping part (41) is configured to clamp the component (70) when mounted inside the cover (40).
However, Mazar discloses: wherein the clamping part (41) is configured to clamp the component (70) when mounted inside the cover (40) in such a way that the clamping part (41). ([0049]; “Covering layer 203 is also stretchable, and is positioned above and adhered to base layer 202” the cover being stretchable and adhered to layer 202 with components 207 and 214 between the layers is seen as layer 203 providing compressive force on the components 207 and 214)
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 flexible cover as disclosed by Libbus in view of Mazar with the stretchable clamping part as further disclosed by Mazar the motivation being to retain circuitry ([0057])
Regarding claim 3, the use of “optionally” is seen as listing alternative and non-essential configurations which therefore do not limit the claim. Libbus in view of Mazar disclose: The cover (40) of claim 1. Libbus further discloses: wherein: the cover (40) is configured for attachment at one or more attachment points (44) to the patch (10) ([Figure 1I]; cover 162 is attached to patch 110 at points 164); and - the patch (10) is configured for attachment to skin of a subject [(108];” Adherent patch 110 comprises a first side, or a lower side 110A, that is oriented toward the skin of the patient when placed on the patient.”); 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).
Regarding claim 4, the use of “optionally” is seen as listing alternative and non-essential configurations which therefore do not limit the claim. The use of “and/or” is seen as listing possible configurations and therefore the claimed invention does not embody all “and/or” statements. Libbus in view of Mazar disclose: The cover (40) of claim 1. Mazar further discloses: wherein: - the at least one clamping part (41) is configured to apply the compression force to the component (70), according to at least one of along at least one direction; ([0049]; “Covering layer 203 is also stretchable, and is positioned above and adhered to base layer 202” the cover being stretchable and adhered to layer 202 with components 207 and 214 between the layers is seen as layer 203 providing compressive force on the components 207 and 214 further the force would be along the direction of the patch) and/or - along a plurality of directions; and/or inwards along at least a part of an outer surface of the component (70); and optionally, wherein the cover (40) consists of a single-piece element; and optionally, wherein the cover (40) comprises at least two flexible and stretchable clamping parts (41); and optionally, wherein the cover (40) comprises at least two flexible and stretchable clamping parts (41) arranged at opposing sides of the component (70) when mounted; and optionally, wherein the cover (40) comprises at least two flexible and stretchable clamping parts (41) configured to apply the compression force to the component (70) when mounted in between the at least two clamping parts (41); and optionally, wherein the cover (40) comprises at least two flexible and stretchable clamping parts (41) at opposing sides of the component (70) when mounted, 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) to the inside of the cover (40) between 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 flexible cover as disclosed by Libbus in view of Mazar with the stretchable clamping part as further disclosed by Mazar the motivation being to retain circuitry ([0057])
Regarding claim 5, The use of “at least one” is seen as the claimed invention only requiring one of the following statements. Libbus in view of Mazar disclose: The cover (40) of claim 1. Libbus further 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; a tensile strength in the range of at least 5.0 N/mm2 to at most 11.0 N/mm2; 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. ([(126); “cover 162 may comprise many known breathable materials, for example polyester, polyamide, and/or elastane (Spandex)” spandex is known to have a shore A hardness in the range of 60 – 80 which is at least 10 and below 90)
Regarding claim 6, Libbus in view of Mazar disclose: The cover (40) of claim 1,wherein the cover comprises Libbus further discloses: and/or combinations thereof. ([(126); “Cover 162 may comprise many known biocompatible cover, casing and/or housing materials, such as elastomers, for example silicone. The elastomer may be fenestrated to improve breathability. In some embodiments, cover 162 may comprise many known breathable materials, for example polyester, polyamide, and/or elastane (Spandex).” Which is seen as a combination of thereof)
Regarding claim 7, Libbus in view of Mazar disclose: The cover of claim 1. Libbus further discloses: A cover assembly configured for attachment to a patch (10), ([Figure 1I]; Libbus discloses Cover 162 attached to patch 111 at points 164) wherein the cover assembly comprises the cover (40) of claim 1 and the component(70) mounted inside the cover (40) ([Figure 1I]; Libbus discloses component 130 and 120 mounted inside cover 162). Libbus does not disclose: the component(70) mounted inside the cover (40) by means of the at least one flexible and stretchable clamping part (41).
However, Mazar discloses: the component(70) mounted inside the cover (40) by means of the at least one flexible and stretchable clamping part (41). ([Figure 2B] Mazar discloses components 207 and 214, which are seen as component, mounted to inside overlayer 216 which is seen as, cover, by flexible covering layer 203
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 flexible cover as disclosed by Libbus in view of Mazar with the stretchable clamping part as further disclosed by Mazar the motivation being to retain circuitry ([0057])
Regarding claim 8, the use of “optionally” is seen as listing alternative and non-essential configurations which therefore do not limit the claim. The use of “and/or” is seen as listing possible configurations and therefore the claimed invention does not embody all “and/or” statements. Libbuss in view of Mazar disclose: The cover assembly of claim 7. Libbus further disclose: wherein the cover (40): - is in direct contact with the component (70) over at least part of its interior surface ([Figure 1I]; Libbus discloses cover 162 in contact with electronic components, which is seen as component, over the interior surface of 162); 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)
Regarding claim 9, Libbus in view of Mazar disclose: The cover assembly of claim 7. Libbus further discloses: A cover slidable with respect to the component (70). ([(133); “Electronics housing 160 can be smooth and allow breathable cover 162 to slide over electronics housing 160, such that motion and/or stretching of cover 162 is slidably coupled with housing 160. “. Libbus does not disclose: wherein the at least one flexible and stretchable clamping part (41) is configured such that, when subjected to changes resulting from flexing and/or stretching of the cover (40).
However, Mazar discloses: wherein the at least one flexible and stretchable clamping part (41) is configured such that, when subjected to changes resulting from flexing and/or stretching of the cover (40) ([Figure 2B] Mazar discloses components 207 and 214, which are seen as component, mounted to inside overlayer 216 which is seen as, cover, by flexible covering layer 203
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 flexible slidable contacting cover as disclosed by Libbus in view of Mazar with the stretchable clamping part as further disclosed by Mazar the motivation being to retain circuitry ([0057])
Regarding claim 10, the use of “optionally” is seen as listing alternative and non-essential configurations which therefore do not limit the claim. Libbus discloses: patch assembly (1) configured for attachment to a subject's skin comprising: ([(133); Libbus discloses a patch that is in contact with a patients skin) at least one cover assembly of claim 7 (Disclosed by Libbus in view of Mazar see above) and a patch (10) configured for removeable attachment to the skin of a subject, ([(25)];” adherent devices is at least one of adhered to or removed from one of the patients.”) whereby the at least one cover assembly is attached to the patch (10) via the cover (40) of the cover assembly,([Figure 1I]; Libbus discloses cover 162 attached to patch 111 at points 164) 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.
Regarding claim 11, Libbus in view of Mazar disclose: The patch assembly (1) of claim 10. Libbus further discloses: wherein the cover (40) comprises a proximal or ant inferior portion (45) ([Figure 1I]; Libbus discloses cover interior portion 160) 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 1I]; Libbbus discloses 160 partially covering components 120 and 130) and wherein the proximal or inferior portion (45) of the cover (40) defines a gap between the component (70) and the patch (10) ([Figure 1I]; Libbus discloses a gap created between components 120, 130 and the patch 111)
Regarding claim 12, Libbus in view of Mazar disclose: The patch assembly (1) of claim 10. Libbus further discloses: wherein the patch assembly (1) further comprises: a sensor configured for measurement of a physiological status in electronic communication with the component (70), ([(111); “Electronics components 130 comprise an activity sensor and activity circuitry 134, impedance circuitry 136 and electrocardiogram circuitry, for example ECG circuitry 136”) wherein the component (70) comprises at least one electronic circuit configured to process, store, and or communicate the measurement of the sensor. ([(111)]; “Electronic components 130 comprise components to take physiologic measurements, transmit data to remote center 106 and receive commands from remote center 106.” )
Regarding claim 13, Libbus in view of Mazar disclose: The patch assembly (1) of claim 10. Libbus further discloses: further comprising a membrane (50) which is permeable to gas ([(131)]; “Gel cover 180 can also keep external moisture, for example liquid water, from penetrating though the gel cover into gel 114A while allowing moisture vapor from the gel, for example moisture vapor from the skin, to transmit through the gel cover.” Wherein water vapor is seen as gas)
Regarding claim 14, Libbus 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) of claim 1(Disclosed by Libbus in view of Mazar). ([(133)]; Libbus discloses components 130 and 120, which are seen as component, disposed between cover 162, which is seen as cover, and patch 111 wherein the cover 162 is attached to patch 111, which is seen as attaching component to patch 111)
Regarding claim 15, Libbus discloses: A method for measurement of a physiological status of a subject, ([(133)]; “dherent patch 110 comprise breathable tape can be configured to couple continuously for at least one week the at least one electrode to the skin so as to measure breathing of the patient.”) the method comprising placing the patch assembly of claim 10 (disclosed by Libbus in view of Mazar) in contact with subject such that the patch (10) is positioned to measure the physiological status; ([(133)]; “such that both the adherent patch and cover can stretch with the skin of the patient”) and measuring the physiological status. ([(133)])
Regarding claim 16, Libbus in view of Mazar disclose: The cover assembly of claim 7. Mazar further discloses: wherein the at least one flexible and stretchable clamping part (41): is in direct contact with the component (70) over at least part of its interior surface ([Figure 2B] cover 203, which is seen as clamping part, in direct contact with components 207 and 214, which are seen as 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 cover assembly as disclosed by Libbus in view of Mazar with the stretchable clamping part as further disclosed by Mazar the motivation being to retain circuitry ([0057])
Regarding claim 18, Libbus in view of Mazar disclose: The patch assembly (1) of claim 13. Libbus further discloses: wherein the membrane (50) is impermeable to fluid. ([(131); “ Gel cover 180 can inhibit flow of gel 114A and liquid”)
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Libbus in view of Mazar further in view of Tucker (US 20200113456 A1) herein referred to as “Tucker”.
Regarding claim 17, Libbus in view of Mazar disclose: The patch assembly (1) of claim 11. Libbus does not disclose: wherein the cover (40) comprises at least one pair of clamping parts (41) arranged at opposing sides of the component (70), 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).
However, Tucker discloses: wherein the cover (40) comprises at least one pair of clamping parts (41) arranged at opposing sides of the component (70), ([Figure 3]; pliable material 10, which is seen as component, clamps 12) 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). ([Figure 3]; Tucker discloses clamps 12 arranged between material 10 and patch 5)
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 assembly as disclosed by Libbuss in view of Mazar with the clamping part as disclosed by Tucker the motivation being mount and secure patient monitoring circuitry ([0032])
Conclusion
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/CASEY GEORGE CHA/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794