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 dressing of claims 19-20 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 8-12, 14, 17-18, 21 are rejected under 35 U.S.C. 102a1 as being anticipated by WO 2017/184857 to Hartmann (Hartmann).
Regarding claim 1, Hartmann teaches a device (38) for externally securing one or more extending elements which extend from external to a patient's body to internal to the patient's body, comprising: a first member (42) comprising one or more channels (44), wherein each of the one or more channels is dimensioned to position a length of one of the one or more extending elements at least partially therein (0058, see fig 3), and one or more engagement members (62; 0066), and a second member (56) comprising one or more cooperating engagement members (58, 60; 0066) configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member (0066).
Regarding claim 2, Hartmann teaches the claim limitations of claim 1, wherein the one or more extending elements pass into the patient's body percutaneously (0060).
Regarding claim 3, Hartmann teaches the claim limitations of claim 1, wherein the first member includes a sufficient number of channels (0060) so that at least two different lengths of one or more of the one or more of extending elements can be positioned within the one or more channels after looping of the one or more extending elements (0060).
Regarding claim 5, Hartmann teaches the claim limitations of claim 1, wherein the one or more cooperating engagement members of the second member are configured to engage with the one or more engagement members of the first member via a snap fit (0066).
Regarding claim 8, Hartmann teaches the claim limitations of claim 1, wherein each of the one or more channels has a width that is approximately equivalent to or less than a diameter of one of the one or more extending elements to be positioned therein (0058).
Regarding claim 9, Hartmann teaches the claim limitations of claim 1, further comprising an adhesive layer (40) on a surface thereof to assist in attaching the device to the patient's body (0056).
Regarding claim 10, Hartmann teaches a method of securing one or more extending elements which extend from external to a patient's body to internal to the patient's body, comprising: placing a device (38) in operative connection with the one or more extending elements (28) , the device comprising a first member (42) comprising one or more channels (44), wherein each of the one or more channels is dimensioned to position a length of one of the one or more extending elements at least partially therein (0058), and one or more engagement members (62; 0066), and a second member (56) comprising one or more cooperating engagement members (58, 60; 0066) configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member (0066), and attaching the device to the patient's body (0055-0056).
Regarding claim 11, Hartmann teaches the claim limitations of claim 10, where one or more extending elements pass into the body percutaneously (0043).
Regarding claim 12, Hartmann teaches the claim limitations of claim 10, wherein the first member includes a sufficient number of channels so that at least two different lengths of one or more of the one or more of extending elements can be positioned within the one or more channels after looping of the one or more extending elements (0060).
Regarding claim 14, Hartmann teaches the claim limitations of claim 10, wherein the one or more cooperating engagement members of the second member are configured to engage with the one or more engagement members of the first member via a snap fit (0066).
Regarding claim 17, Hartmann teaches the claim limitations of claim 10, wherein each of the one or more channels has a width that is approximately equivalent to or less than a diameter of one of the one or more extending elements to be positioned therein (0058).
Regarding claim 18, Hartmann teaches the claim limitations of claim 10, wherein the device is attached to the skin of the patient via an adhesive (40; 0056).
Regarding claim 21, Hartman teaches a sytem, comprising: one or more extending elements (28) which extend from external to a patient's body to internal to the patient's body; and a device (38) for externally securing the one or more extending elements comprising a first member (42) comprising one or more channels (44- see fig. 3), wherein each of the one or more channels is dimensioned to position a length of one of the one or more extending elements at least partially therein (0058), and one or more engagement members (62; 0066), and a second member (56) comprising one or more cooperating engagement members (58, 60; 0066) configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member (0066).
Claims 1, 4, 7, 10, 13, and 16 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by U.S. Publication No. 2019/0015635 to Rosenhan (Rosenhan).
Regarding claim 1, Rosenhan teaches a device (300) for externally securing one or more extending elements (400) which extend from external to a patient's body to internal to the patient's body, comprising: a first member (302) comprising one or more channels (304), wherein each of the one or more channels is dimensioned to position a length of one of the one or more extending elements at least partially therein ([0018], and one or more engagement members (314a, 314b; [0019]), and a second member (340) comprising one or more cooperating engagement members (342a, 342b; [0019] configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member ([0019-0020]).
Regarding claim 4, Rosenhan teaches the claim limitation of claim 1, wherein the one or more cooperating engagement members of the second member are configured to slidably engage with the one or more engagement members of the first member (0019).
Regarding claim 7, Rosenhan teaches the claim limitation of claim 1, further comprising an antibacterial composition (0033).
Regarding claim 10, Rosenhan teaches a method of securing one or more extending elements (400) which extend from external to a patient's body to internal to the patient's body, comprising: placing a device (300) in operative connection with the one or more extending elements (400; 0016) , the device comprising a first member (302) comprising one or more channels (304), wherein each of the one or more channels is dimensioned to position a length of one of the one or more extending elements at least partially therein ([0018]), and one or more engagement members (314a, 314b; 0019), and a second member (340) comprising one or more cooperating engagement members (342a, 342b; 0019) configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member (0019), and attaching the device to the patient's body (0018).
Regarding claim 13, Rosenhan teaches the claim limitation of claim 10, wherein the one or more cooperating engagement members of the second member are configured to slidably engage with the one or more engagement members of the first member (0019).
Regarding claim 16, Rosenhan teaches the claim limitation of claim 10, wherein the device further comprises an antibacterial composition (0033).
Claims 1, 6, 10, and 15 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by U.S. Patent No. 7,457,506 to Osborne II (Osborne).
Regarding claim 1, Osborne teaches a device (300) for externally securing one or more extending elements which extend from external to a patient's body to internal to the patient's body (abstract), comprising: a first member (320) comprising one or more channels (325), wherein each of the one or more channels is dimensioned to position a length of one of the one or more extending elements at least partially therein (Col. 5 ln. 15-23, 32-39), and one or more engagement members (345), and a second member (330) comprising one or more cooperating engagement members (see fig. 6- element with which 345 is pushed into – col. 5 ln. 15-23) configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member (Col. 5 ln. 15-39).
Regarding claim 6, Osborne teaches the claim limitations of claim 1, wherein the second member is connected to the first member via a hinging connection (Col. 3ln. 23-27, Col. 5 ln. 15-23).
Regarding claim 10, Osborne teaches a method of securing one or more extending elements which extend from external to a patient's body to internal to the patient's body (Col. 3 ln. 60-65), comprising: placing a device (300) in operative connection with the one or more extending elements (Col. 4 ln. 4-9), the device comprising a first member (320) comprising one or more channels (325), wherein each of the one or more channels (325) is dimensioned to position a length of one of the one or more extending elements at least partially therein (Col. 4 ln. 5-9), and one or more engagement members (345), and a second member (330) comprising one or more cooperating engagement members (see fig. 6- element with which 345 is pushed into – col. 5 ln. 15-23) configured to form a cooperating engagement with the one or more engagement members of the first member so that a surface of the second member is positioned adjacent to the one or more channels of the first member when the second member is engaged with the first member (Col. 5 ln. 15-39), and attaching the device to the patient's body.
Regarding claim 15, Osborne teaches the claim limitations of claim 10, wherein the second member is connected to the first member via a hinging connection (Col. 3ln. 23-27, Col. 5 ln. 15-23).
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.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hartmann over U.S. Publication No. 2016/0243338 to Vaillancourt et al. (Vallaincourt).
Regarding claim 19, Hartmann teaches the claim limitations of claim 10, but fails to explicitly teach placing a dressing over the device.
Vallaincourt teaches placing a dressing over the device (0012, 0013, 0015).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included placing a dressing over the device in order to allow the patient be ambulatory while protecting the site in a sterile manner.
Regarding claim 20, Hartmann in view of Vallaincourt teach the claim limitations of claim 19, where Vallaincourt further teaches wherein the dressing comprises a transparent portion positioned over the device (0013, 0015).
Conclusion
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REBECCA E. EISENBERG
Supervisory Patent Examiner
Art Unit 3781
/REBECCA E EISENBERG/ Supervisory Patent Examiner, Art Unit 3781
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