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 11/26/2025 has been entered. Claims 22-25, 27-35, 37-38, 40-41 are pending in the application. Applicant' s amendments to the claims have overcome every 112(b) rejection previously set forth in the Final Office Action mailed 07/23/2025.
Claim Rejections - 35 USC § 103
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.
Claim 22-25, 27-34, 38, 40-41 is rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 2010/0198162) in view of Porat (US 2011/0009792) and further in view of Rodzewicz (US 2018/0008476) and further in view of Heinecke (US 5,088,483).
Regarding claim 22, Propp discloses a tape system comprising a first tape (110, Fig 4) comprising: a first surface (114, Fig 3) with a first tape adhesive (Para 0026) and a second surface (116, Fig 3) opposite the first surface; a midsection (section of 110 near perforation 130, Fig 1) extending in a longitudinal direction, the midsection having a first end and a second end; a first leg (section of 110 to the left of the midsection, Fig 1) extending from the midsection at the first end in a first lateral direction; a second leg (section of 110 to the right of the midsection, Fig 1) extending from the midsection at the second end in the first lateral direction; a perforation (130, Fig 1) set extending laterally across the midsection; and a dressing (150, Fig 4) the body layer having a first major surface (top surface facing away from the patient’s skin), a second major surface (surface in contact with the patient’s skin) opposite the first major surface, the second major surface-comprising a dressing adhesive (Para 0029, lines 1-13).
Propp is silent regarding a pair of tabs extending from the midsection; a second tape comprising: a first surface with a second tape adhesive and a second surface opposite the first surface; a midsection extending in a longitudinal direction, the midsection having a first end and a second end; a first leg extending from the midsection at the first end in a first lateral direction; a second leg extending from the midsection at the second end in the first lateral direction; the dressing comprising a transparent polymeric body layer defined by a perimeter; and wherein the second tape is configured to apply over the first tape with the first lateral direction of the first tape opposed to the first lateral direction of the second tape; wherein the midsection of the first tape is configured to align with and spaced apart from the midsection of the second tape; and wherein at least a portion of the first and second tapes are configured to overlay the dressing.
Porat discloses a tape system (System of Fig 4) comprising a first tape (3, Fig 2a) comprising: a first surface with a first tape adhesive (lower surface of first tape 3) and a second surface opposite the first surface (upper surface of first tape 3); a midsection (See annotated Fig 2a) extending in a longitudinal direction, the midsection having a first end and a second end; a first leg (See annotated Fig 2a) extending from the midsection at the first end in a first lateral direction; a second leg (See annotated Fig 2a) extending from the midsection at the second end in the first lateral direction; and a second tape (4, Fig 3a) comprising: a first surface with a second tape adhesive (lower surface of first tape 3) and a second surface opposite the first surface (upper surface of first tape 3); a midsection (See annotated Fig 3a) extending in a longitudinal direction, the midsection having a first end and a second end; a first leg (See annotated Fig 3a) extending from the midsection at the first end in a first lateral direction; a second leg (See annotated Fig 3a) extending from the midsection at the second end in the first lateral direction; and a dressing (2, Fig 1a) comprising a first major surface (upper surface of dressing 2), a second major surface (lower surface of dressing 2) opposite the first major surface; wherein the second tape is configured to be applied over the first tape with the first lateral direction of the first tape opposed to the first lateral direction of the second tape (See Fig 4; Para 0021); wherein the midsection of the first tape is configured to be aligned with but spaced apart from the midsection of the second tape; and wherein at least a portion of the tape system overly the dressing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the tape of Propp to include a second tape as taught by Porat in order to further secure the dressing around the medical device (Para 0026).
The modified invention Propp and Porat discloses all of the elements of the invention as discussed above, however, is silent regarding a pair of tabs extending from the midsection; the second major surface of the dressing comprising a dressing adhesive.
Rodzewicz teaches an analogous tape (104, Fig 1a) comprising a pair of tabs (108, 109, Fig 1a) extending from the midsection (105, Fig 1a) (as each half of the tape extends from the midsection and the tabs are part of those halves, they necessarily extend from the midsection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first tape to include a pair of tabs as taught by Rodzewicz in order to allow a user to easily lift the tape from either side (Para 0072).
The modified invention of Propp, Porat, and Rodzewicz discloses all of the elements of the invention as discussed above, however, is silent regarding the dressing comprising a transparent polymeric body layer defined by a perimeter.
Heinecke teaches an analogous dressing (10, Fig 3) wherein the dressing comprises a transparent polymeric body layer defined by a perimeter (Col 2, lines 31-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dressing to comprise a transparent polymeric body layer as taught by Heinecke in order to have a material for medical dressing that permits observation of the point of entry of the catheter into the patient and that is impermeable to liquid water and bacteria but is permeable to moisture vapor (Col 5, lines 53-56).
Regarding claim 23, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the longitudinal and first lateral directions in the first tape are perpendicular to each other (See annotated Fig 1 of Propp).
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Regarding claim 24, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the midsection of the first tape extends in a straight line (See Fig 1 -Propp).
Regarding claim 25, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses all of the elements of the invention as discussed above, however, is silent regarding the midsection of the first tape is curved.
Porat, in the embodiment of Fig 2d, teaches that the midsection of the first tape is curved (See Fig 2d; Para 0021 and 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first tape to have a curved midsection in place of a straight midsection as Porat teaches that a curved midsection and a straight midsection can be used to achieve the same result (affixing a pad and device to the skin as described in Para 0021) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Regarding claim 27, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the second tape is applied over the first tape with the first leg of the second tape applied over the second leg of the first tape, and with the second leg of the second tape applied over the first leg of the first tape (See Fig 4; Para 0027-0028 -Porat).
Regarding claim 28, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses at least one of the first tape and second tape comprises a reinforcement layer (120, Fig 1 -Propp) (Para 0029 -Propp).
Regarding claim 29, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the first tape and the second tape are identical (See Figs 2a and 3a -Porat; in the modified invention, the second tape would be a duplicate of Propp’s tape as to have all of the features of the first tape).
Regarding claim 30, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the system is configured such that a device (“extruding object”, Para 0021 -Porat) extends between the midsection of the first tape and midsection of the second tape (See Fig 4 -Porat).
Regarding claim 31, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the midsection of the first tape is configured to overlay the device and the midsection of the second tape is configured to extend under the device (As the device is being recited functionally, the tape system just has to be capable of the midsection of the first tape overlaps the device and the midsection of the second tape is under the device. Since the tape and their midsection are arrange in Fig 4 of Porat in such a way that if a tube is oriented in the gap between the midsection at an acute angle relative to the skin of the patient, the portion of the tube under the skin would be overlapped by the midsection of the first tape and the portion of the tube outside of the skin would overlap the midsection of the second tape. Thus, the tape system is capable of such an arrangement).
Regarding claim 32, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the device is a tube (152, Fig 4; Para 0029).
Regarding claim 33, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the entire first surface (114, Fig 3 -Propp) of the first tape is configured to overlay the first major surface (top surface facing away from the patient’s skin -Propp) of the dressing (See Fig 4 -Propp).
Regarding claim 34, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the second major surface (surface of 150 in contact with the patient’s skin -Propp) of the dressing overlies a substrate (i.e. patient’s skin), and at least a portion of the tape system overlies the substrate (See Fig 4, Para 0029 -Propp)
Regarding claim 38, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses a kit comprising the tape system of claim 22 (See rejection of claim 22 above).
Regarding Claim 40, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses the perforation set (130, Fig 1 -Propp) extends along an axis that extends between the pair of tabs (108,109, Fig 1a -Rodzewicz) (The perforation set of Propp is along a central axis and the tabs of Rodzewicz are on either side of the central axis 105. Thus, in the combined invention, the perforation set would extend between the pair of tabs).
Regarding Claim 41, the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses all of the elements of the invention as discussed above, however, is silent regarding the first and second tapes are C-shaped.
Porat, in the embodiment of Fig 2d and 3d, teaches that the first tape and second tape are C-shaped (See Figs 2d and 3d; Para 0021 and 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second tapes to have a C-shape as Porat teaches that a curved midsection and a straight midsection can be used to achieve the same result (affixing a pad and device to the skin as described in Para 0021) and thus were art-recognized equivalents at the time the invention was made. It has been held that substituting parts of an invention involves only routine skill in the art.
Claims 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Propp (US 2010/0198162) in view of Porat (US 2011/0009792) and further in view of Rodzewicz (US 2018/0008476) and further in view of Heinecke (US 5,088,483) and further in view of Kay (US 2012/0203182).
Regarding claim 35 the modified invention of Propp, Porat Rodzewicz, and Heinecke discloses method of securing a device to a substrate (Para 0002 -Propp), the method comprising: applying the dressing of claim 22 over a portion of the device (Para 0029 -Propp); applying the first tape adhesive at the midsection of the first tape of claim 22 with the first leg and second leg of the first tape adjacent to the device and overlying the substrate (See Fig 4 -Propp); applying the midsection of the second tape of claim 22 with the second tape adhesive towards the substrate such that the first leg of the second tape overlies the second leg of the first tape (Para 0021, 0026-0028 -Porat), the second leg of the second tape overlies the first leg of the first tape (See Fig 4 -Porat), and the device extends between the midsection of the first tape and the midsection of the second tape (Para 0021, 0026-0028 -Porat).
the modified invention Propp, Porat Rodzewicz, and Heinecke is silent regarding applying the adhesive at the midsection of the first tape of claim 22 over a portion of the device and applying the midsection of the second tape of claim 22 under a portion of the device.
Kay teaches an analogous method of securing a device to a substrate (Para 0003) comprising applying the adhesive at the midsection of the first tape over a portion of the device (Para 0011; See Figs 12-16, the first tape is secured over the device) and applying the midsection of the second tape under a portion of the device (See Figs 19-25, the midsection of the second tape is shown under the device (tubing) at least in Figs. 24 and 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Porat to include applying the midsection of the first tape over a portion of a device and applying the midsection of the second tape under a portion of the device as taught by Kay in order to prevent lateral, longitudinal, and rotational movement of the medical tubing as well as preventing the medical tubing from moving away from the body (Para 0011).
Regarding claim 37, the modified invention of Propp, Porat Rodzewicz, Heinecke, and Kay discloses the dressing is applied over the portion of the device prior to the applications of the first and second tapes (Para 0029 -Propp; Para 0027-0028 -Porat).
Response to Arguments
Applicant’s argument filed 11/26/2025, on pages 6-7,regarding Porat failing to teach failing to teach the dressing comprises a transparent polymeric body layer have been fully considered but are moot in view of the current rejection that now relies on Propp to teach the dressing and Heinecke to teach the transparent polymeric material of the dressing layer as detailed above.
Applicant’s argument filed 11/26/2025, on pages 8-9, regarding one of ordinary skill would not combine Porat’s pad with Holms discontinuously applied adhesive have been fully considered but are moot in view of the current rejection that no longer relies on Holms to teach the claimed elements.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785