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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2026 has been entered.
Response to Amendment
The amendment filed 07/14/2026 has been entered. Claims 22-25, 27-31, 33-35, 37-38, 41-46 are pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first tape is asymmetrical” in claim 43 and “the first tape and the second tape are non-identical” in claim 44 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 46 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 46 recites “comprising permitting lateral movement of the device within the gap along the width thereof”. There is no support for this in the instant specification. In fact, paragraph 003 states that “movement of an IV catheter while the catheter is inserted in a vein is a leading cause of catheter failure”. The entire purpose of the instant invention seems to be to prevent movement of the device.
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 24-25 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.
Claims 24 and 25 recite “the midsection, the first leg, and the second leg”. It is unclear if this limitation is refereeing to the first tape, the second tape, or both tapes. For the sake of examination, the limitation will be interpreted as reciting “the midsection, the first leg, and the second leg of the first tape and the second tape”.
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.
Claims 22-25, 27-31, 33-34, 38, 41, 44-45 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 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 (See annotated Fig 1) extending in a longitudinal direction, the midsection having a first end and a second end; a first leg (See annotated Fig 1) extending from the midsection at the first end in a first lateral direction; a second leg (See annotated 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 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; and 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; wherein the midsection of the first tape is configured to align with and spaced apart from the midsection of the second tape to define a gap therebetween that exhibits a height in the first lateral direction and a width in the longitudinal direction that is greater than the height; and wherein the first and second tapes are configured to only partially 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 the tape system overlays 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 and the medical device (Para 0026). Examiner notes that the combined invention of Propp and Porat would teach the first tape is configured to align with and spaced apart from the midsection of the second tape to define a gap therebetween that exhibits a height in the first lateral direction and a width in the longitudinal direction that is greater than the height (The recess 134 of tape 110 is U-shaped as seen in Fig 1 and described in Para 0030 of Propp. If two of these tapes were placed as taught by Porat to overlap about the recess, the resulting gap could take an oval-like shape having a width that is greater than the height. It is important to note that this limitation is a functional limitation and there is nothing preventing a user from placing the tape in a manner that reads on the functional limitation and thus, the combination of Propp and Porat reads on this limitation) and the first and second tapes are configured to only partially overlay the dressing (Para 0029 -Propp; the tapes or anchors are only placed on a portion the dressing 150 where the tubing 152 exits the dressing such that the catheter 156 is still visible from the window of the dressing).
The modified invention of Propp and Porat 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).
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Regarding claim 23, the modified invention of Propp, Porat and Heinecke discloses the longitudinal direction is perpendicular to both the first lateral direction of the first tape and the first lateral direction of the second tape (See annotated Fig 1 of Propp).
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Regarding claim 24, the modified invention of Propp, Porat, and Heinecke discloses the midsection, the first leg, and the second leg each extend in a straight line (See Fig 1 -Propp).
Regarding claim 25, the modified invention of Propp, Porat, and Heinecke discloses all of the elements of the invention as discussed above, however, is silent regarding the midsection , the first leg, and the second leg are each curved.
Porat, in the embodiment of Fig 2d, teaches that the midsection, the first leg, and the second leg of the first tape and the second tape are curved (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 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, and Heinecke discloses the second tape is applied over the first tape with the first leg of the second tape applied over a portion less than the entirety of the second leg of the first tape, and the second leg of the second tape applied over a portion less than the entirety of the first leg of the first tape (See Fig 4; Para 0027-0028 -Porat).
Regarding claim 28, the modified invention of Propp, Porat, and Heinecke discloses the first tape and the second tape comprises a reinforcement layer (120, Fig 1 -Propp) arranged on and extending along the first leg, the midsection, and the second leg (Para 0029 -Propp).
Regarding claim 29, the modified invention of Propp, Porat, 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, 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, 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 33, the modified invention of Propp, Porat, and Heinecke discloses the entire first tape is configured to overlay the dressing (See Fig 4 -Propp; as this is a functional limitation, the entire first tape just needs to be capable of overlaying the dressing. There is nothing preventing a user from positioning the entirety of tape 110 of Propp to overlay the dressing 150).
Regarding claim 34, the modified invention of Propp, Porat, and Heinecke discloses the dressing is configured to overly a substrate (i.e. patient’s skin), and at least a portion of the first and second tape are configured to overly the substrate (See Fig 4, Para 0029 -Propp)
Regarding claim 38, the modified invention of Propp, Porat, and Heinecke discloses a kit comprising the tape system of claim 22 (See rejection of claim 22 above).
Regarding Claim 41, the modified invention of Propp, Porat, 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.
Regarding Claim 44, the modified invention of Propp, Porat, and Heinecke discloses all of the elements of the invention as discussed above, however, is silent regarding the first tape and the second tape are non-identical.
Porat teaches the first tape and the second tape are non-identical (Para 0026-0028; tapes 3 and 4 can be any of the shaped illustrated in Figs 2 and 3).
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 and/or the second tape such that they are not identical as Porat teaches that each of the different tape shapes 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 45, the modified invention of Propp, Porat, and Heinecke discloses the first tape and the second tape each exhibit a C-shape having a first surface area, and wherein the reinforcement layer (120, Fig 1 -Propp) exhibits the C-shape having a second surface area less than the first surface area (See annotated Fig 1; the reinforming layer has a smaller surface area than the tape).
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Claims 35, 37, 46 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 and Heinecke discloses a method of using the tape system of claim 22, the method comprising: inserting a device into a substrate (Para 0029 -Propp); applying the dressing over a portion of the device (Para 0029); applying, with the tape adhesive, the first leg and second leg of the first tape adjacent to the device and over a portion less than the entirety of the dressing and a portion of the substrate (Para 0029, Fig 4 -Propp); applying, with the tape adhesive, the midsection of the second tape over a portion of the dressing (Para 0029 -Propp); applying, with the tape adhesive, the first leg of the second tape over a portion less than the entirety of the second leg of the first tape, over and beyond an outer perimeter of the second leg of the first tape, and over a portion less than the entirety of the dressing; applying, with the tape adhesive, the second leg of the second tape over a portion less than the entirety of the first leg of the first tape, over and beyond an outer perimeter of the first leg of the first tape, and over a portion less than the entirety of the dressing (Para 0021 -Porat; also see annotated Fig 4); extending the device through the gap (Para 0021 -Porat; Para 0029 -Propp).
The modified invention Propp, Porat, and Heinecke is silent regarding applying, with the tape adhesives the midsection of the first tape over a portion of the device and overlaying a portion of the device atop the midsection of the second tape.
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).
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Regarding claim 37, the modified invention of Propp, Porat, 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).
Regarding Claim 46, the modified invention of Propp, Porat, Heinecke, and Kay discloses permitting lateral movement of the device within the gap along the width thereof (Para 0030 -Propp; partial removal of the tape/anchor would allow lateral movement within the gap).
Claim 42 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 Heinecke (US 5,088,483) and further in view of Rodzewicz (US 2018/0008476).
Regarding Claim 42, the modified invention of Propp, Porat, and Heinecke discloses the second tape further comprises: a perforation set (130, Fig 1 -Propp) extending across the midsection along an axis (Para 0030 -Propp), however, is silent regarding a first tab extending from the first end of the midsection on a first side of the axis and in a second lateral direction opposite the first lateral direction; and a second tab extending from the second end of the midsection on a second side of the axis and in the second lateral direction
Rodzewicz teaches an analogous tape (104, Fig 1a) comprising a first tab (108, Fig 1a) extending from the first end of the midsection (105, Fig 1a) on a first side of the axis (as each half of the tape extends from the midsection and the tabs are part of the halves, they necessarily extend from the midsection) and in a second lateral direction opposite the first lateral direction; and a second tab (109, Fig 1a) extending from the second end of the midsection on a second side of the axis and in the second lateral direction (See Fig 1a)
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 second 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; See Figs 3a-3b).
Claim 43 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 Heinecke (US 5,088,483) and further in view of Esaki (US 2009/0104402).
Regarding Claim 43, the modified invention of Propp, Porat, and Heinecke discloses all of the elements of the invention as discussed above, however, is silent regarding the first tape is asymmetrical.
Esaki teaches a tape that is asymmetrical (See tape 10 in Fig 3).
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 be asymmetrical as Esaki teaches that tape can be shaped to correspond to the shape of the affected area or application site (Para 0008).
Response to Arguments
Applicant’s argument filed 07/14/2026, on pages 7-8, regarding Propp, Porat, Rodzewicz, and Heinecke failing to teach the gap having a width greater than a height have been fully considered but is not persuasive. As detailed in the rejection of claim 22 above, the combined invention of Propp and Porat would teach the first tape is configured to align with and spaced apart from the midsection of the second tape to define a gap therebetween that exhibits a height in the first lateral direction and a width in the longitudinal direction that is greater than the height. The recess 134 of tape 110 is U-shaped as seen in Fig 1 and described in Para 0030 of Propp. If two of these tapes were placed as taught by Porat to overlap about the recess, the resulting gap could take an oval-like shape having a width that is greater than the height. It is important to note that this limitation is a functional limitation and there is nothing preventing a user from placing the tape in a manner that reads on the functional limitation and thus, the combination of Propp and Porat reads on this limitation.
Applicant’s argument filed 07/14/2026, on pages 9, regarding Propp, Porat, Rodzewicz, Heinecke, and Kay failing to teach the amended limitation oof claim 35 have been fully considered but are not persuasive. As illustrated in annotated Fig. 4, the first leg of the second tape lies over a portion less than the entirety of the second leg of the first tape, over and beyond an outer perimeter of the second leg of the first tape. The same is also true for the second leg of the second tape relative to the first leg of the first tape. The language is not specific enough to dictate what side of the leg the corresponding leg extends over and beyond.
Conclusion
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
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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