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
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the figures appear to be poor scans of product diagrams. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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 two planes and four axes in claims 1-22 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 § 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, 8, 11-13, 17, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bierman et al (US 20040204684).
Regarding claim 1, Bierman discloses:
An intravenous (IV) line securement system (Fig. 4) comprising: a first layer (32b) including first and second opposing surfaces, wherein the first surface of the first layer (32b) couples to an adhesive that is configured to couple the first layer (32b) to a patient's skin (¶0075 – underside of layer 32b has an adhesive to secure to a patient); a second layer (30b) including first and second opposing surfaces, wherein: (a) the first surface (underside) of the second layer (30b) is fixedly coupled to the second surface of the first layer (32b; ¶0075), and (b) the second layer (30b) is more rigid than the first layer (32b) (¶0051, 0054 – the second layer 30 is hard plastic such as polypropylene or polyethylene while the first layer 32 is a flexible structure meant to conform to a body); a third layer (46) including first and second opposing surfaces, wherein: (a) the first surface (underside) of the third layer (46) is fixedly coupled to the second surface of the second layer (30b) (¶0073), (b) the third layer (46) is less rigid than the second layer (30b) (¶0073, 0051 – the third layer 46 is a foam versus the hard plastic of the second layer 30b), (c) the second surface of the third layer (46) couples to an adhesive (24b) that is configured to couple to the IV line (¶0073), (d) the second surface of the third layer (46) includes a channel (44) configured to receive the IV line (¶0072), (e) the first surface of the third layer (46) is primarily disposed in a first plane (a horizontal plane encompasses most of the third layer 46), and (f) a second plane, parallel to the first plane, intersects the third layer (46) and the channel (44) (a horizontal plane above the first plane can be drawn that still intersects the third layer 46 and therefore the channel 44).
Regarding claim 2, Bierman discloses:
The IV line securement system of claim 1, wherein: a second axis (an axis offset from the cradle 42), orthogonal to the first plane, intersects the first and second layers (32b, 30b) but not the third layer (46) (if the axis does not overlap with the cradle 42, it does not intersect with the third layer 46); a third axis (an axis intersecting the cradle 42), orthogonal to the first plane, intersects the first, second, and third layers (if the axis overlaps with the cradle 42, it intersects all three layers).
Regarding claim 8, Bierman discloses:
The IV line securement system of claim 2, wherein a first axis (axis offset from the retainer 30b), orthogonal to the first plane, intersects the first layer (32b) but not the second layer (30b) and not the third layer (46).
Regarding claim 11, Bierman discloses:
The IV line securement system of claim 1, wherein: the first layer (32b) includes no sublayers; the second layer (30b) includes no sublayers; and the third layer (46) includes no sublayers.
Regarding claim 12, Bierman discloses:
An intravenous (IV) line securement system (Fig. 4) comprising: a first layer (32b) including first and second opposing surfaces, wherein the first surface of the first layer (32b) couples to an adhesive that is configured to couple the first layer (32b) to a patient's skin (¶0075 – underside of layer 32b has an adhesive to secure to a patient); a second layer (30b) including first and second opposing surfaces, wherein the first surface (underside) of the second layer (30b) is fixedly coupled to the second surface of the first layer (32b; ¶0075); a third layer (46) including first and second opposing surfaces, wherein: (a) the first surface (underside) of the third layer (46) is fixedly coupled to the second surface of the second layer (30b) (¶0073), (b) the second surface of the third layer (46) couples to an adhesive (24b) that is configured to couple to the IV line (¶0073), (c) the second surface of the third layer (46) includes a channel (44) configured to receive the IV line (¶0072), (d) the first surface of the third layer (46) is primarily disposed in a first plane (a horizontal plane encompasses most of the third layer 46), and (e) a second plane, parallel to the first plane, intersects the third layer (46) and the channel (44) (a horizontal plane above the first plane can be drawn that still intersects the third layer 46 and therefore the channel 44).
Regarding claim 13, Bierman discloses:
The IV line securement system of claim 12, wherein: a second axis (an axis offset from the cradle 42), orthogonal to the first plane, intersects the first and second layers (32b, 30b) but not the third layer (46) (if the axis does not overlap with the cradle 42, it does not intersect with the third layer 46); a third axis (an axis intersecting the cradle 42), orthogonal to the first plane, intersects the first, second, and third layers (if the axis overlaps with the cradle 42, it intersects all three layers).
Regarding claim 17, Bierman discloses:
The IV line securement system of claim 13, wherein a first axis (axis offset from the retainer 30b), orthogonal to the first plane, intersects the first layer (32b) but not the second layer (30b) and not the third layer (46).
Regarding claim 22, Bierman discloses:
The IV line securement system of claim 12, wherein: the first layer (32b) includes no sublayers; the second layer (30b) includes no sublayers; and the third layer (46) includes no sublayers.
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.
Claims 3-7, 14, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Howell et al (US 2015/00224285).
Regarding claim 3, Bierman discloses the IV line securement system of claim 2 but is silent regarding “in a system open orientation the third axis intersects the first layer only one time; in a system closed orientation the third axis intersects the first layer two times respectively at first and second locations; the second and third layers are between the first and second locations.” However, Howell teaches a securement system (Fig. 54) for securing a catheter to a patient (Abstract; ¶0077), thus being in the same field of endeavor, that teaches a system that includes a flap (708) that is part of the first layer (104) and is folded over to further secure the catheter line (¶0137). This results in an open orientation, (Fig. 54) where a vertical axis offset from the second layer (102) only goes through the first layer (104), and a closed orientation (Fig. 67), where that same vertical axis goes through the first layer (104) twice at first and second locations on the flap (708) and the main body of the first layer (104). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Bierman to incorporate a flap as part of the first layer taught by Howell in order to provide a means of further securing the catheter line.
Regarding claim 4, Bierman in view of Howell discloses the IV line securement system of claim 3, wherein the first and second locations taught by the modification in view of Howell in the rejection of claim 3 are included on a monolithic portion of the first layer (¶0137 – the flap 708 and the first layer 104 are monolithic and unitary).
Regarding claim 6, Bierman discloses:
The IV line securement system of claim 2, wherein: a fourth axis (axis intersecting the cradle 42), orthogonal to the first plane, intersects the first, second, and third layers (32b, 30b, 46) and the adhesive (24b) coupled to the second surface of the third layer (46).
Bierman is silent regarding “a system open orientation the fourth axis intersects the first layer only one time” and “a system closed orientation the fourth axis intersects the first layer two times respectively at first and second locations; the second and third layers are between the first and second locations.” However, Howell teaches a securement system (Fig. 54) for securing a catheter to a patient (Abstract; ¶0077), thus being in the same field of endeavor, that teaches a system that includes a flap (708) that is part of the first layer (104) and is folded over to further secure the catheter line (¶0137). This results in an open orientation, (Fig. 54) where a vertical axis offset from the second layer (102) only goes through the first layer (104), and a closed orientation (Fig. 67), where that same vertical axis goes through the first layer (104) twice at first and second locations on the flap (708) and the main body of the first layer (104). This would result in the retainer (102) being sandwiched between two layers of the first layer (104) as seen in Fig. 68. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Bierman to incorporate a flap as part of the first layer taught by Howell in order to provide a means of further securing the catheter line.
Regarding claim 7, Bierman in view of Howell discloses the IV line securement system of claim 6, wherein the first and second locations taught by the modification in view of Howell in the rejection of claim 6 are included on a monolithic portion of the first layer (¶0137 – the flap 708 and the first layer 104 are monolithic and unitary).
Regarding claim 14, Bierman discloses the IV line securement system of claim 13 but is silent regarding “a system open orientation the third axis intersects the first layer only one time” and “a system closed orientation the third axis intersects the first layer two times respectively at first and second locations; the second and third layers are between the first and second locations.” However, Howell teaches a securement system (Fig. 54) for securing a catheter to a patient (Abstract; ¶0077), thus being in the same field of endeavor, that teaches a system that includes a flap (708) that is part of the first layer (104) and is folded over to further secure the catheter line (¶0137). This results in an open orientation, (Fig. 54) where a vertical axis offset from the second layer (102) only goes through the first layer (104), and a closed orientation (Fig. 67), where that same vertical axis goes through the first layer (104) twice at first and second locations on the flap (708) and the main body of the first layer (104). This would result in the retainer (102) being sandwiched between two layers of the first layer (104) as seen in Fig. 68. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Bierman to incorporate a flap as part of the first layer taught by Howell in order to provide a means of further securing the catheter line.
Regarding claim 16, Bierman in view of Howell discloses the IV line securement system of claim 14, wherein the first and second locations taught by the modification in view of Howell in the rejection of claim 14 are included on a monolithic portion of the first layer (¶0137 – the flap 708 and the first layer 104 are monolithic and unitary).
Regarding claim 18, Bierman in view of Howell discloses:
The IV line securement system of claim 13, wherein: a fourth axis (axis intersecting the cradle 42), orthogonal to the first plane, intersects the first, second, and third layers (32b, 30b, 46) and the adhesive (24b) coupled to the second surface of the third layer (46).
Bierman is silent regarding “a system open orientation the fourth axis intersects the first layer only one time” and “a system closed orientation the fourth axis intersects the first layer two times respectively at first and second locations; the second and third layers are between the first and second locations.” However, Howell teaches a securement system (Fig. 54) for securing a catheter to a patient (Abstract; ¶0077), thus being in the same field of endeavor, that teaches a system that includes a flap (708) that is part of the first layer (104) and is folded over to further secure the catheter line (¶0137). This results in an open orientation, (Fig. 54) where a vertical axis offset from the second layer (102) only goes through the first layer (104), and a closed orientation (Fig. 67), where that same vertical axis goes through the first layer (104) twice at first and second locations on the flap (708) and the main body of the first layer (104). This would result in the retainer (102) being sandwiched between two layers of the first layer (104) as seen in Fig. 68. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Bierman to incorporate a flap as part of the first layer taught by Howell in order to provide a means of further securing the catheter line.
Regarding claim 19, Bierman in view of Howell discloses the IV line securement system of claim 18, wherein the first and second locations taught by the modification in view of Howell in the rejection of claim 18 are included on a monolithic portion of the first layer (¶0137 – the flap 708 and the first layer 104 are monolithic and unitary).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Howell further in view of Bracken et al (US 2013/0150827).
Regarding claim 5, Bierman in view of Howell discloses the IV line securement system of claim 3 but is silent regarding “at least one compliant pad connected to the first layer, wherein in the system closed orientation the at least one compliant pad and the third layer are configured to sandwich a portion of the IV line between the at least one compliant pad and the third layer.” However, Bracken teaches an IV line securement system (Fig. 24), thus being in the same field of endeavor, that encloses a medical line (182) between two layers of material (10, 20c) that uses a compliant pad (30; Fig. 27) in the form of a tacky gel pad (¶0016) that inhibits lateral and longitudinal motion of the medical article by conforming to the outer surface of the medical article. This results in a portion of the medical article being sandwiched between the compliant pad (30) and the top layer of the base (20c). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the system of Bierman to incorporate a compliant pad as taught by Bracken in order to provide sufficient structure to prevent lateral and longitudinal motion of the medical article, as recognized by Bracken.
Regarding claim 15, Bierman in view of Howell discloses the IV line securement system of claim 14 but is silent regarding “at least one compliant pad to the first layer at the second location.” However, Bracken teaches an IV line securement system (Fig. 24), thus being in the same field of endeavor, that encloses a medical line (182) between two layers of material (10, 20c) that uses a compliant pad (30; Fig. 27) in the form of a tacky gel pad (¶0016) that inhibits lateral and longitudinal motion of the medical article by conforming to the outer surface of the medical article. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the system of Bierman to incorporate a compliant pad as taught by Bracken in order to provide sufficient structure to prevent lateral and longitudinal motion of the medical article, as recognized by Bracken.
Allowable Subject Matter
Claims 9, 10, 20, and 21 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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