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 .
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 internal layer including one or more lines (recited in claim 5, also note 112 rejection below) and the crease (recited in claim 15) 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 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 2, 3, 5, 12, 13, 19 and 20 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.
Claim 2 recites “wherein the padding layer…”, but claim 1 stated the bandage “optionally” comprises a padding layer. Thus, it is unclear if the padding layer is still optional or now required. It is suggested that if the padding layer is not required, the claim be amended to recite that the bandage further comprises the padding layer. Similar issues apply to claim 13.
Claim 3 recites “an additional agent comprising an antibiotic, lidocaine, medication, or combination thereof”. It is unclear if this is one of the “one or more agents” contained in the container layer or located elsewhere on the bandage. Furthermore, the claim recites the external layer surrounds the internal layer and container, and the specification discloses that the external layer shields the internal layer from air and water. Therefore, it is unclear what benefit that additional agents would be given that the medicinal agents are shielded and surrounded by the external layer ([0037] for example). Similar issues apply to claim 19.
Claim 5 recites the “internal layer includes one or more lines through which the hardening agent can flow”. Applicant’s specification discloses that Figure 1B includes dotted lines to indicate dissemination of the hardening agent through the internal layer 110. Therefore, it is unclear if applicant’s invention comprises actual lines in the internal layer through which the hardening agent can flow, or if the “lines” are merely for illustrative purposes to show dissemination. If they are physical lines in the internal layer they should be shown as such in the drawings.
Claim 12 recites “two or more container layers”. It is unclear if this includes, or is in addition to, the container layer already recited in claim 1. For purposes of examination, it is being interpreted that the container layer comprises two or more container layers.
Claim 20 recites “the container layer is configured to be selectively disrupted to cause dissemination of the one or more agents from the container layer into one or more other layers”. It is unclear if the “one or more other layers” comprises the internal layer, external layer, or other additional layers. Furthermore, the claim recites the external layer surrounds the internal layer and the specification discloses that the external layer shields the internal layer from air and water ([0037] for example). Therefore, it is unclear what benefit that additional agents would be given that the medicinal agents are shielded and surrounded by the external layer.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-13, 15-18, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Termanini (US 7,172,565 B2).
Regarding claim 1, Termanini discloses a customizable bandage (Figures 1-3) comprising: an internal layer (3); a container layer (1) containing one or more agents (1a; Col. 2, lines 63-67; Col. 3, lines 15-32), the one or more agents comprising a hardening agent (the gel 1a comprises hardeners and accelerators for curing Col. 2, lines 1-6; Col. 2, lines 63-67; Col. 3, lines 15-32); an external layer (6) surrounding the internal layer and the container layer (Figures 1-3); optionally, an adhesive layer disposed on a lower surface of the external layer; and optionally, a padding layer (4) disposed on a lower surface of the external layer, wherein the hardening agent and internal layer are formulated such that dissemination of the hardening agent from the container layer causes the internal layer to harden into a semi-rigid state (Col. 2, lines 1-6; Col. 3, lines 26-40).
Regarding claim 2, Termanini discloses wherein the padding layer (4) is longitudinally aligned with the container layer on an opposite side of the internal layer (Figures 1-3).
Regarding claim 4, Termanini discloses wherein the internal layer comprises a material configured to wick and/or absorb the hardening agent (Col. 3, lines 15-25 and 33-42).
Regarding claim 6, Termanini discloses (i) the hardening agent comprises a curable resin formulated to cure upon exposure to air and/or water; or (ii) the hardening agent comprises water (Col. 1, lines 58-67; Col. 4, lines 1-8) and/or air and the internal layer includes a curable resin formulated to harden upon exposure to the water and/or air (Col. 3, lines 33-41).
Regarding claim 7, Termanini discloses the external layer is waterproof and/or airproof (Col. 3, lines 20-25).
Regarding claim 8, Termanini discloses wherein the container layer is configured to be breakable to release the hardening agent upon manually applied pressure (Col. 3, lines 12-20 and 42-53).
Regarding claim 9, Termanini discloses wherein the customizable bandage has a rectangular (Figures 1-3), butterfly, star, spherical, ellipsoid, or wedge shape.
Regarding claim 10, Termanini discloses wherein the container layer includes two or more separate sections (see upper layer and lower layer of pouch 1; Figures 1-3; alternatively, left and right sections).
Regarding claim 11, Termanini discloses wherein a first section includes the hardening agent and a second section includes one or more other agents Col. 1, line 58-Col. 2, line 6; Col. 4, lines 1-7).
Regarding claim 12, Termanini discloses two or more container layers (see upper layer and lower layer of pouch 1; Figures 1-3).
Regarding claim 13, Termanini discloses wherein the padding layer comprises two or more pads (see upper layer of padding 4 and lower layer of padding 4), each longitudinally aligned with a corresponding container layer (see Figures 1-3).
Regarding claim 15, Termanini discloses wherein the container layer (1) includes a crease (see folded sides forming a crease on left and right sides, Figures 1-3)
Regarding claim 16, Termanini discloses wherein the crease is configured to break upon exposure to sufficient manually applied pressure to the container layer (Col. 3, lines 12-18 and 42-53).
Regarding claim 17, Termanini discloses (Col. 3, lines 12-18 and 42-53; Figures 1-3).
Regarding claim 18, Termanini discloses a method of managing or preventing a wound or injury (Abstract; Col. 1, lines 7-10), the method comprising: applying the semi-rigid bandage of claim 1 to a target site (see rejection of claim 1; Col. 1, lines 7-10; Col. 3, lines 20-25); activating the container layer to disseminate the hardening agent into the internal layer (Col. 3, lines 12-22); and allowing the internal layer of the customizable bandage to harden into a semi-rigid state (Col. 2, lines 1-6; Col. 3, lines 26-40).
Regarding claim 20, Termanini discloses a customizable bandage (Abstract; Figures 1-3) comprising: an internal layer (3); a container layer (1) containing one or more agents, the one or more agents comprising a medicinal agent (the gel can be any water-laden gel commonly employed in the medical or cosmetics industry Col. 1, lines 58-67); an external layer (6) surrounding the internal layer and the container layer (Figures 1-3); optionally, an adhesive layer disposed on a lower surface of the external layer; and optionally, a padding layer (4) disposed on a lower surface of the external layer, wherein the container layer is configured to be selectively disrupted to cause dissemination of the one or more agents from the container layer into one or more other layers (Col. 3, lines 15-25 and 42-53).
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 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Termanini (US 7,172,565 B2) in view of Malbey et al (US 2022/0125644).
Regarding claim 3, Termanini discloses that as applied above but does not disclose an additional agent comprising an antibiotic, lidocaine, medication, or combination thereof. Malbey teaches a semi-rigid bandage that comprises an antibiotic, lidocaine, medication, or combination thereof ([0026]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Termanini having the additional agent taught by Malbey for preventing infection and increasing comfort to the user.
Regarding claim 19, Termanini discloses that as applied above but does not disclose internal layer further includes an anesthetic, analgesic, antimicrobial, anti-inflammatory, anti-allergy agent, or combination thereof. Malbey teaches a semi-rigid bandage that comprises an internal layer further includes an anesthetic, analgesic, antimicrobial, anti-inflammatory, anti-allergy agent, or combination thereof ([0026]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Termanini having the additional agent taught by Malbey for preventing infection and increasing comfort to the user.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Termanini (US 7,172,565 B2) in view of Scholz et al (US 6,100,206).
Regarding claim 5, Termanini discloses that as applied above but does not disclose the internal layer (3) includes one or more lines through which the hardening agent can flow. Scholz teaches an orthopedic casting article that includes one or more lines (26) through which the hardening agent can flow (Figure 5; Col. 4, lines 35-46). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the internal layer of Termanini having lines as taught by Scholz for facilitating transport of the hardening agent across the layer.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Termanini (US 7,172,565 B2) in view of Ferguson et al (US 6,042,557).
Regarding claim 14, Termanini discloses that as applied above but does not disclose a hook and loop attachment. Ferguson teaches an orthopedic splint having a hook and loop attachment (26, Figure 1; Col. 6, lines 50-54). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Termanini having a hook and loop attachment as taught by Ferguson to hold the bandage on the user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786