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 .
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 1, 2, 7-9, 13, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zurovcik US Patent Application Publication 2016/0045375 in view of Leiboff US Patent Application Publication 2017/027416.
As to claim 1, Zurovcik teaches a tissue interface 20 for connecting a drain to a patient at a skin surface, the tissue interface comprising:
a mounting flange 26 comprising:
a passage 50 extending through the mounting flange 26 (Fig. 2; para. 0110) and configured to receive at least one catheter forming a drain tube 24 therethrough to extend through an opening in the skin surface of the patient to drain fluid from within the patient (Figs. 1-3; paras. 0108-0111);
Zurovcik does not teach a plurality of suture tabs arranged about the passage to secure the mounting flange against the skin surface of the patient. Leiboff teaches a wound drain (Abstract) with a plurality of suture tabs arranged about the passage to secure the mounting flange against the skin surface of the patient – where Leiboff teaches each drain 100 may be secured in this position by a suitable securing mechanism or technique, for example, with a suture tie 7 by passing a suture needle and thread through the skin and the flange 110 of the drain 100 and tying to form one or more stitches that pass through the skin 3 and flange 110 of the drain 100. The suture may be passed through the aperture 111 in the flange 110 or through the elastomeric substance of the flange. Instead of a suture tie 7, other comparable securing mechanisms known to those skilled in this field may be used (Leiboff Fig. 5A; paras. 0056, 0067 and Fig. 8, step 1). Leiboff teaches the suture may be passed through the aperture 111 in the flange 110 (para. 0056), thus apertures 111 form the plurality of suture tabs (Leiboff Figs. 4b, 4D, 4E). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Zurovcik with the plurality of suture tabs taught in Leiboff in order to close the surgical incision and secure the drain (Leiboff para. 0054).
Zurovcik/Leiboff teach an attachment system extending about the passage 50 – where Zurovcik teaches an adhesion region 56 extending around passage 50 (Zurovcik Fig. 2; para. 0110) and configured to removably engage the at least one catheter (drain tube 24) to secure the at least one catheter to the mounting flange 26 – where Zurovcik teaches tube 24 is inserted through the novel symmetrical flange 26 (Fig. 1; para. 0108).
As to claim 2, Zurovcik/Leiboff teaches the tissue interface of claim 1, further comprising medical treatment system where Zurovcik teaches additional components may be added or put into additional kits that are used in typical dressing changes, such as medications (Zurovcik para. 0179) configured to deliver a medical treatment to the skin surface proximate to the opening in the skin surface.
As to claim 7, Zurovcik/Leiboff teaches the plurality of suture tabs 111, 111C are arranged about a periphery of the mounting flange or on three sides of the mounting flange (Leiboff Figs. 4B, 4D, 4D).
As to claim 8, Zurovcik/Lieboff discloses the tissue interface of claim 1, wherein the mounting flange includes a void 46 configured to slide the at least one catheter 24 into and out from the passage 50 of the mounting flange 26 (Zurovcik Figs. 2 and 3; para. 0109).
As to claim 9, Zurovcik/Lieboff teach the tissue interface of claim 1, further comprising at least one lock configured to engage the attachment system to removably connect the catheter to the mounting flange – where Zurovcik teaches the flange includes an integral connector capable of mating with flexible tubing such as shown in Fig. 43. (Fig. 43; paras. 0110, 0186).
As to claim 13, Zurovcik teaches a kit (para. 0179) for connecting a drain to a patient at a skin surface, the kit comprising:
a mounting flange 26 comprising:
a passage 50 extending through the mounting flange 26 (Fig. 2; para. 0110) and configured to receive at least one catheter forming a drain tube 24 therethrough to extend through an opening in the skin surface of the patient to drain fluid from within the patient (Figs. 1-3; paras. 0108-0111);
Zurovcik does not teach a plurality of suture tabs arranged about the passage to secure the mounting flange against the skin surface of the patient. Leiboff teaches a wound drain (Abstract) with a plurality of suture tabs arranged about the passage to secure the mounting flange against the skin surface of the patient – where Leiboff teaches each drain 100 may be secured in this position by a suitable securing mechanism or technique, for example, with a suture tie 7 by passing a suture needle and thread through the skin and the flange 110 of the drain 100 and tying to form one or more stitches that pass through the skin 3 and flange 110 of the drain 100. The suture may be passed through the aperture 111 in the flange 110 or through the elastomeric substance of the flange. Instead of a suture tie 7, other comparable securing mechanisms known to those skilled in this field may be used (Leiboff Fig. 5A; paras. 0056, 0067 and Fig. 8, step 1). Leiboff teaches the suture may be passed through the aperture 111 in the flange 110 (para. 0056), thus apertures 111 form the plurality of suture tabs (Leiboff Figs. 4b, 4D, 4E). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Zurovcik with the plurality of suture tabs taught in Leiboff in order to close the surgical incision and secure the drain (Leiboff para. 0054).
Zurovcik/Leiboff teaches the tissue interface of claim 1, further comprising medical treatment system where Zurovcik teaches additional components may be added or put into additional kits that are used in typical dressing changes, such as medications (Zurovcik para. 0179) configured to deliver a medical treatment to the skin surface proximate to the opening in the skin surface.
Zurovcik/Leiboff teach an attachment system extending about the passage 50 – where Zurovcik teaches an adhesion region 56 extending around passage 50 (Zurovcik Fig. 2; para. 0110) and configured to removably engage the at least one catheter (drain tube 24) to secure the at least one catheter to the mounting flange 26 – where Zurovcik teaches tube 24 is inserted through the novel symmetrical flange 26 (Fig. 1; para. 0108).
As to claim 17, Zurovcik/Leiboff teaches the tissue interface of claim 1, wherein the mounting flange includes a void 46 configured to slide the at least one catheter 24 into and out from the passage 50 of the mounting flange 26 (Zurovcik Figs. 2 and 3; para. 0109).
As to claim 20, Zurovcik/Leiboff/Alden teach a method of installing a drain in a patient, the method comprising:
positioning at least one catheter 24 to arrange a distal end 40 to drain fluid from inside the patient (Zurovcik Fig. 3; paras. 0108-0110);
positioning the at least one catheter 24 to arrange a proximal end to extend externally from the patient to dispel the fluid drained from inside the patient from the distal end from the patient (Zurovcik Figs. 1-3; para. 0108-0111);
arranging the at least one catheter 24 to extend through a passage 50 of a mounting flange 26 arranged to secure the at least one catheter 24 to a tissue or skin interface of the patient (Zurovcik Figs. 5A, 5B; para. 0110-0111);
suturing the mounting flange to the tissue or skin interface of the patient using a plurality of suture tabs extending from the mounting flange – where ; and
Zurovcik does not teach suturing the mounting flange to the tissue using a plurality of suture extending from the mounting flange. Leiboff teaches a wound drain (Abstract) with a plurality of suture tabs arranged about the passage to secure the mounting flange against the skin surface of the patient – where Leiboff teaches each drain 100 may be secured in this position by a suitable securing mechanism or technique, for example, with a suture tie 7 by passing a suture needle and thread through the skin and the flange 110 of the drain 100 and tying to form one or more stitches that pass through the skin 3 and flange 110 of the drain 100. The suture may be passed through the aperture 111 in the flange 110 or through the elastomeric substance of the flange. Instead of a suture tie 7, other comparable securing mechanisms known to those skilled in this field may be used (Leiboff Fig. 5A; paras. 0056, 0067 and Fig. 8, step 1). Leiboff teaches the suture may be passed through the aperture 111 in the flange 110 (para. 0056), thus apertures 111 form the plurality of suture tabs (Leiboff Figs. 4b, 4D, 4E). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Zurovcik with the plurality of suture tabs taught in Leiboff in order to close the surgical incision and secure the drain (Leiboff para. 0054).
Zurovcik/Lieboff teach attaching the at least one catheter to the mounting flange using an attachment system – where Zurovcik teaches the flange includes an integral connector capable of mating with flexible tubing 24 such as shown in Fig. 43. (Fig. 43; paras. 0110, 0186). Additionally, Figs. 1-3, 5A, 5B, and 10-13 show the catheter 24 attached to the mounting flange.
Claims 10-12, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zurovcik US Patent Application Publication 2016/0045375 in view of Leiboff US Patent Application Publication 2017/027416 and further in view of Alden et al. US Patent Application Publication 2019/0254863.
As to claim 10, Zurovcik/Leiboff teaches the tissue interface of claim 9. However, Zurovcik/Leiboff do not teach the at least one lock includes a snap fitting to removably connect the attachment system to the mounting flange. Alden teaches a fluid collection system having a fluid remover connector operable to detachably couple with a wafer connector (Abstract). Alden teaches wafer connector 132 and fluid remover connector 134 form a snap-fit arrangement where the wafer connector 132 extends radially upward from flange 131 and couples to fluid remover connector 134 via mating mechanical interlocks 136 (Figs. 4a, 4b; para. 0051). It would have been obvious to one having ordinary skill in the art to use mating mechanical locks to form a snap-fit connection in the invention of Zurovcik/Leiboff for the benefit of providing a secure connection where the leaked fluid from a surgical incision can flow into a fluid collector as taught in Alden (Alden Figs. 3, 4a, and 4b; paras. 0044, and 0048-0051).
As to claim 11, Zurovcik/Leiboff/Alden do not specifically teach the tissue interface comprising a Luer lock to removably connect the attachment system to the mounting flange. However, Alden teaches a fluid collection system having a fluid remover connector operable to detachably couple with a wafer connector and further comprising a Luer lock to removably connect the attachment system to the mounting flange – where Alden teaches a circular ring-shaped wafer connector 132 extends radially upward from flange 131 and couples to fluid remover connector 134 in a snap-fit arrangement. Alden further teaches those of skill in the art will appreciate, however, that couplings other than snap fit arrangements may be used (Alden para. 0051). It would have been obvious to one of ordinary skill in the art to provide Zurovcik/Leiboff/Alden with Luer lock closure since Alden teaches couplings other than snap fit arrangements may be used and since the articles are from the same field of endeavor, fluid collection, and solve the same problem of providing a secure connection between fluid collection components.
As to claim 12, Zurovcik/Leiboff/Alden teach the tissue interface of claim 9, wherein the mounting flange is semi- rigid to deform to engage the skin surface – where Zurovcik teaches the mounting flange 26 is not rigid, but flexible enough to deform so the flange and tube can be positioned and re-positioned as needed by the patient or by a healthcare professional (Zurovcik para. 0111).
As to claims 18 and 19, Zurovcik/Leiboff/Alden teach the kit of claim 13, further comprising a lock configured to engage the catheter to removably connect to the mounting flange – where Alden teaches wafer connector 132 and fluid remover connector 134 form a snap-fit arrangement where the wafer connector 132 extends radially upward from flange 131 and couples to fluid remover connector 134 via mating mechanical interlocks 136 (Figs. 4a, 4b; para. 0051). It would have been obvious to one having ordinary skill in the art to use mating mechanical locks to form a snap-fit connection on the invention of Zurovcik/Leiboff for the benefit of providing a secure connection where the leaked fluid from a surgical incision can flow into a fluid collector as taught in Alden (Alden Figs. 3, 4a, and 4b; paras. 0044, and 0048-0051).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zurovcik US Patent Application Publication 2016/0045375 in view of Leiboff US Patent Application Publication 2017/027416 and further in view of Doshi et al. US Application Publication 2016/0256665. Zurovcik/Leiboff teaches the present invention substantially as claimed. Zurovcik/Leiboff do not teach the medical treatment pack includes at least one of an antibiotic or an anesthetic. Doshi teaches a medical support device to be placed on top of a wound. Doshi teaches a medicament such as an antibiotic or petroleum jelly may be present in the chamber, providing a moist environment for wound healing. Other medicaments may be topical anesthetics which may be helpful to numb an area prior to a medical or surgical intervention (Doshi paras. 0187 , 0191, 0194, 0237). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide an antibiotic or anesthetic for the medicament of Zurovcik/Leiboff for the benefits taught in Doshi.
Allowable Subject Matter
Claims 3-6 and 15-16 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.
The following is a statement of reasons for the indication of allowable subject matter: Claims 3 and 15 require a trough formed in the mounting flange and a medicament arranged in the trough. The cited prior art does not teach or suggest a medicament arranged in a trough on the tissue interface. Claims 4-6 depend from claim 3 and claim 16 depends from claim 15.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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