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 . Claims 1-18 are currently pending with claims 13-18 standing as withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species II (Figures 5-7) in the reply filed on 05/20/2026 is acknowledged. Claims 1-5 are confirmed as generic with claims 6-12 being drawn to the elected species.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 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 non-obviousness.
Claims 1-5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. US 10,596,295 (hereinafter Larson) in view of Weimann et al. US 2010/0076387 (hereinafter Weimann).
Regarding claim 1, Larson discloses a flexible adhesive patch (element 106, column 4, lines 10–20; element 200, column 6, lines 1-15) corresponding to the lower cover film, having a first adhesive member on a first surface (element 220, column 6, lines 15–30) and a second adhesive member on a second surface opposite the first surface (element 222, column 6, lines 15-30), the second adhesive member comprising a sensor-affixing feature (element 202) and a device-affixing feature (element 204, column 6, lines 30-45; column 7, lines 35-55; column 8, lines 1–20) configured to adhere the biomedical device to the lower cover film (element 246, column 7, lines 40-55). Larson does not disclose an upper cover film, a cover film configured to fold into a bag to accommodate a biomedical device, nor the second adhesive member configured to adhere an edge portion of the upper cover film to an edge portion of the lower cover film to form the bag.
Weimann teaches a patch device (element 20) comprising a first section (element 22) and a second section (element 24) - corresponding to the upper and lower cover films - joined by a hinge (element 42) along a folding plane (element 40) and configured to fold into a closed bag-like configuration ([0027][0028][0039][0042]). Weimann further teaches adhesives (elements 30, 32) on the inner surfaces of the respective sections configured to hold the sections together and engage the enclosed payload in the closed configuration ([0030][0042]). It would have been obvious to the skilled artisan before the effective filing date to incorporate the foldable bag structure of Weimann with the device of Larson and to configure the second adhesive member (elements 202, 204) to additionally adhere the edge portion of the upper cover film to the edge portion of the lower cover film when folded, as predictable results would have ensued (a replaceable biomedical device enclosed within a foldable film cover wherein the second adhesive member both secures the device and closes the bag).
Regarding claim 2, Larson does not disclose the upper cover film having a larger area than the lower cover film. Weimann teaches that the release liner (element 38) includes a projecting edge (element 41) that extends beyond the perimeter of the first and second sections (elements 22, 24, [0036]). It would have been obvious to the skilled artisan before the effective filing date to make the upper cover film larger in area than the lower cover film (both of Weimann) in lieu of the cover films of Larson as predictable results would have ensued (reliable coverage of the second adhesive member upon folding; the adhesives are also different sizes and require different sized cover films).
Regarding claim 3, Larson discloses the first adhesive member disposed so as to entirely cover the first surface of the lower cover film (element 220, column 6, lines 15-30).
Regarding claim 4, Larson discloses the second adhesive member comprising the sensor-affixing feature (element 202) in the sensor mounting region (element 226) and the device-affixing feature (element 204) in the device mounting region (element 228) having an outer shape in plain view that is smaller than the outer shape of the lower cover film (element 200, column 6, lines 30-45; column 7, lines 35-50; column 8, lines 1-20).
Regarding claim 5, Larson discloses the second adhesive member comprising a multiple-use adhesive layer (element 264, column 8, lines 35-55) configured for repeated removal of a device, while the first adhesive member (element 220) is configured for reliable adhesion on the first surface (column 6, lines 15-30), thereby disclosing an adhesion strength of the second adhesive member that is smaller than the adhesion strength of the first adhesive member. The exact adhesion strength is not disclosed, only the function that is required of it, and as such, it would have been obvious to the skilled artisan before the effective filing date to utilize adhesives of different strengths as predictable results would have ensued (allowing the biomedical device to be replaced without disturbing the first adhesive member, each of these tasks requires a different strength).
Regarding claim 9 , Larson is silent on the folding plane. Weimann teaches the first section (element 22) and second section (element 24) joined to each other along the folding plane (element 40), which extends linearly, and foldable along that line via the hinge (element 42, [0027], [0028], [0039]). It would have been obvious to the skilled artisan before the effective filing date to incorporate the foldable bag structure of Weimann with the device of Larson as predictable results would have ensued (a replaceable biomedical device enclosed within a foldable film cover wherein the second adhesive member both secures the device and closes the bag).
Claims 6-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Larson in view of Weimann, and in further view of LaPrade et al. US Patent 6,159,497 (hereinafter LaPrade).
Regarding claim 6, Larson discloses a first separator releasably adhered to the first adhesive member (element 208, column 6, lines 46-67) and a second separator releasably adhered to the second adhesive member (element 206, column 8, lines 56-67; column 9, lines 1-20), the second separator shaped to define a cutout area (element 270) partially surrounding the sensor-affixing feature (element 202). Larson is however silent on the second separator including a slit dividing it into a first separator portion covering the first adhesion region and a second separator portion covering the second adhesion region.
LaPrade discloses a second separator (element 31) comprising a slit (element 38) dividing it into a first portion (element 31a) covering the adhesion region to which the biomedical device is adhered and a second portion (element 31b) covering the remaining adhesion region, each independently removable via respective pull-tabs (elements 33a, 33b, column 3, lines 10-45; column 4, lines 20-50). It would have been obvious to the skilled artisan before the effective filing date to incorporate the slit (element 38) of LaPrade into the second separator (element 206) of Larson as predictable results would have ensued (sequential, error-protected peeling of the first and second adhesion regions of the second adhesive member).
Regarding claim 7, Larson is silent on the slit. LaPrade further discloses that the slit (element 38) may be configured such that a region of the first portion (element 31a) defined by the slit (element 38) remains on the adhesive surface when the first portion (element 31a) is peeled away (column 4, lines 40-60). It would have been obvious to the skilled artisan before the effective filing date to incorporate the slit (element 38) of LaPrade into the second separator (element 206) of Larson as predictable results would have ensued (sequential, error-protected peeling of the first and second adhesion regions of the second adhesive member). It would have been further obvious to the skilled artisan before the effective filing date to configure the slit (element 38) of LaPrade as a closed loop defining a region that is not in contact with the periphery of the first separator portion and remains on the second adhesive member when the first separator portion is peeled off, as predictable results would have ensued (providing a non-adhesive region facilitating clean removal of the biomedical device).
Regarding claim 8, Larson does not disclose a third surface of the upper cover film adhered to the first separator portion of the second separator. Weimann teaches that the inner surface of the first section (element 26) interacts with the release liner (element 38) as the device (element 20) transitions between open and closed configurations ([0039][0042]), while LaPrade teaches coupling the pull-tabs (elements 33a, 33b) to the respective liner portions (elements 31a, 31b) to guide sequential peeling at the slit (element 38, column 3, lines 50-67; column 4, lines 1-30). Therefore, it would have been obvious to the skilled artisan before the effective filing date to adhere the third surface of the upper cover film to the first separator portion (element 31a) of the second separator (element 206) as predictable results would have ensued (opening the upper cover film automatically exposes the first adhesion region of the second adhesive member, reducing the risk of the user peeling the wrong separator portion).
Regarding claim 10, see contents of rejected claim 9 above.
Regarding claim 11, Larson is silent on the folding. Weimann teaches that the folding plane (element 40) extends linearly in a direction orthogonal to the folding direction, and the adhesives (elements 30, 32) abut at the folding plane (element 40, [0027][0030]), such that the first adhesive member (element 220) and first separator (element 208) have respective sides at the joining portion that extend linearly in a direction substantially orthogonal to the folding direction as a direct consequence of the fold line geometry of Weimann. It would have been obvious to the skilled artisan before the effective filing date to orient the respective sides of the first adhesive member and first separator in this manner as taught by Weimann with the device of Larson as predictable results would have ensued (a consistent fold line preventing misalignment of the cover film layers when folded into the bag; this is additional motivation after the initial combination of rejected claim 1 above).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 12 discloses that the first separator (generally a release liner) and/or the first adhesive have a greater rigidity compared to the upper film, lower cover film, and second adhesive member. The films are not known to be rigid, and the adhesives can in many instances have slightly different strengths, not they do not detail rigidity. Lee et al. US Patent 11,219,413 at element 206 details a more rigid separator but it would be the wrong one based on the above combination (the second not the first separator). Abercrombie et al. US Patent 11,337,632 teaches a similar design with the rigid separator being at 810 and also in the wrong place. Adjusting the rigidity of elements is a well-known concept however adjusting the first separator given its placement would not have been obvious to the skilled artisan before the effective filing date.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights