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 Objections
Claim objected to because of the following informalities:
Applicant amended to include the term "a" without cancelling the previous term "the". Thus the claim reads "toward the a distal end". Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 09/01/2025 have been fully considered but they are not persuasive. Applicant argues that the limitation brought into claim 1 of “resisting axial movement” is not taught by the prior art. The examiner notes that per paragraph 0066 of Hart (as previously applied), the seals (interpreted as the clamps) comprise an orifice through which an appropriate instrument is entered through. Per para. 0068, the end of the instrument is moved through said orifice (145) “appropriately without distorting the sensitive orifice”. Therefore as the seals are configured to occluded an object within the space between both seals and prevent the instrument from distorting the orifice between the seals, it is interpreted that axial movement of the chest tube is resisted by the seals, interpreted as clamps, due resisting the movement (distortion) of the chest tube in relation to the insertion device. Further, per paragraph 0070, Hart teaches that the seals provide strict requirements regarding friction, drag, and durability. Therefore as the seals provide friction to the instrument (as the instrument passes through the seals) it is interpreted that the friction provides at least some resistance in movement of the instrument. The rejection below has been updated in view of the claim amendments and new claim 20.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Clamp tab gap, reference as number 38 in figures 8a-8d, per paragraphs 0060 and 0061. 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. 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 § 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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathis et al. US 2006/0167416, hereafter Mathis, in view of Hart et al. US 2005/0216028, Aho et al. US 2017/0360290, Karpiel US 5320602, and Lazarus et al. US 4351333, hereafter Hart, Aho, Karpiel, and Lazarus, respectively, where Hart is provided in the IDS.
Regarding claim 8, Mathis discloses
A method of inserting a chest tube into a chest cavity of a patient (Fig. 19 (see sheet 26 of 28), figure 21 where the anatomic location is the chest, para. 0082); inserting and advancing a needle over a top edge of a target rib of the patient into a pleural space (para. 0014, where the pleural layers are pierced with any chest procedure) of the chest cavity until air or fluid is aspirated (para. 0143). The examiner notes that per paragraph 0143, Mathis discloses that the device disclosed may be used with the Seldinger method. The Seldinger method is disclosed to consist of steps of inserting a needle into the patient, inserting a guidewire through and past the distal end of the needle, withdrawing the needle, enlarging the puncture site (if desired), advancing an outer sheath over the guidewire toward the target site, removing the guidewire, and inserting the steerable member. The examiner notes that each of these steps is detailed in paragraph 0143 and are disclosed to be useable with the device of Mathis.
Therefore Mathis further discloses inserting a guidewire into the pleural space of the chest cavity via the needle (para. 0143, inserting guidewire through distal end of needle), and removing the needle (0143) from the inserted guidewire; dilating a tract that runs along the guidewire (enlarging the puncture site and guidewire pathway, where para 0098 details that the sheath may act as a dilator) and advancing a chest tube insertion apparatus along the guidewire (advancing outer sheath), translating the chest tube insertion apparatus along the guidewire until the distal tip of the stylet is located within the pleural space of the chest cavity of the patient (positioning the outer sheath device in the desired location, where previously the desired location was disclosed to be a chest cavity, and where the steerable device may be a stylet (abstract)), and removing the guidewire (removing the guidewire post outer sheath insertion); positioning the chest tube insertion apparatus in the pleural opening oriented to a desired direction for chest tube insertion (positioning outer sheath device in the desired location), and removing the stylet (para. 0099, where the steerable device (previously disclosed to be a stylet) is removed); inserting a chest tube through the lumen of the sheath body to a desired distance past the tapered tube clamp at the distal end of the sheath body (para. 0099, where after the stylet is removed and replaced with a suction source);
Mathis further discloses the structure of the chest tube insertion apparatus comprising a sheath (figure 4a-e, outer sheath (110)) having a stylet installed in the sheath (steerable member (120) disclosed to be a stylet per abstract), the sheath including a sheath body having a distal end and a proximal end (wherein the distal end is interpreted as the insertion end and the proximal end is opposite), a sheath lumen defined axially through the sheath body from the distal end to the proximal end of the sheath (lumen (112)), the stylet having a distal tip (104) and a proximal tip (102), and a stylet lumen defined axially through the stylet from the distal tip to the proximal tip of the stylet (stylet lumen (122) seen in figure 4E);
Mathis however fails to teach that the device comprises a tapered tube clamp at the distal end of the sheath body.
Hart teaches a surgical access device comprising a tubular member and is thus considered analogous to the claimed invention. Hart teaches that the device comprises an elongated body (figure 7,8 (105)) through which an instrument is inserted into (figure 7 showing a large instrument (200) and figure 8 showing a small instrument (250), para. 0065). The elongated body is tapered at an end to facilitate placement through a body wall (para. 0011) and comprises, at the insertion end, a sealing component consisting of seals (140 and 120) to prevent backflow (para. 0064). As seen in figure 7 and 8, these seals (disclosed per para. 0064 as duckbill seals) are interpreted as a clamp at the tapered end. Therefore to aid in placement of a tubular access device into the body and to prevent backflow through the access device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the tubular access device of Mathis with a taper and tube clamp at the distal end.
Mathis however fails to specifically disclose the administering a local anesthesia to the patient within the boundaries of the surgical site and connecting an end of the chest tube that remains outside of the patient to a suction operated pleural drainage system and applying suction to the chest tube at an appropriate negative pressure for reflating a lung of the patient or evacuating fluid from the chest cavity and confirming the chest tube is in a desired position and the chest tube is functional.
Aho teaches a chest tube insertion device and method and is thus considered analogous to the claimed invention. Aho teaches that the device may be used in the pleural space (para. 0023) where the device and operation consists of inserting a tube into said space, attaching the tube to a suction device, and removing air from the space, allowing the lung to re-expand (para. 0023, see also figure 1 (tube (110) and suction source (120), para. 0026). Aho additionally teaches that said procedures are commonly done under local anesthesia (para. 0023). The examiner notes that the removal of fluid and reinflating of the lung is interpreted as confirmation of the tube being in the correct position and function. Should applicant disagree, Aho teaches that the determination of the chest tube being positioned properly is dependent on a detected pressure level (figure 2 (250). Therefore as Aho discloses that chest tube insertion in the pleural space is typically done under local anesthesia, and comprises steps of connecting a suction tube to an external suction source to aid in removal of air and/or fluid from the lungs in order to re-inflate the lungs, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to connect the suction tube disclosed in Mathis to an external suction source to aid in fluid removal, as well as provide local anesthesia for the procedure.
Mathis further fails to explicitly disclose removing the chest tube insertion sheath from the chest tube while the chest tube remains in place inside the body and while suction to the chest tube is maintained.
Karpiel teaches an insertion guide and is thus considered analogous to the claimed invention. Karpiel teaches that said insertion guide may consist of a sheath or catheter, where said sheath is longitudinally splitable to aid in the removal process, where said splitable sheath splits away from a guidewire or inserted material (Column 1, lines 14-23). Per column 4, lines 14-20, the device of Karpiel is disclosed to have two longitudinal grooves cut into the outer surface of the catheter (or sheath per column 1 citation) to facilitate the removal of said catheter (sheath) without disturbing the placement of the guidewire (or other inserted material per column 1 citation). Therefore as Karpiel teaches that external sheaths for insertable material during surgical procedures commonly have tearable lines for removal of the sheath without disturbing the inserted material’s function, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the device of Mathis with two longitudinal grooves to facilitate removal of the sheath after insertion of the suction tube.
Mathis however fails to discloses applying a sterile cleaning and draping to a surgical site on the patient.
Lazarus teaches a fluid treatment surgical access device and method of operation and is thus considered analogous to the claimed invention (abstract). Lazarus teaches that for the operation, an area of the skin is prepared for the device by cleaning it with an antiseptic agent, and after cleaning a body drape is applied to leave a patch of prepared skin ready for operation. After which, a local anesthesia is applied. Therefore, as Lazarus teaches that access devices for fluid treatment comprises steps of preparing a patient for the operation including, cleaning the skin, covering the patient with a drape to provide a small window of prepared skin for access, and applying local anesthesia, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to, for the device of Mathis, prepare a patient in the same manner due to Mathis also disclosed a fluid treatment access device.
The examiner notes that in response to the amendments to the claims filed 09/01/25, Hart reads to the claimed limitations as per the previous rejection of claim 12. As detailed above under the same rejection, it was found obvious to modify the distal end opening of Mathis to comprise a taper and duckbill seals to prevent backflow. As seen in figure 7 and 8 of Hart, these seals are plural ((120 and 140) disclosed per para. 0064 as duckbill seals) and are interpreted and angled radially inward as seen in said figures, due to the inward caving of said seals. Per the abstract and as detailed under para. 0088 of Hart, the duckbill seals are occlusive with regard to the object within the space between the opposing seals. Therefore as there is a complete seal formed and occlusion of the object between the two seals, it is interpreted that the seals provide resistance to axial movement. The examiner further notes that per paragraph 0066 of Hart, the seals comprise an orifice through which an appropriate instrument is entered through. Per para. 0068, the end of the instrument is moved through said orifice (145) “appropriately without distorting the sensitive orifice”. Therefore as the seals are configured to occluded an object within the space between both seals and prevent the instrument from distorting the orifice between the seals, it is interpreted that axial movement of the chest tube is resisted by the seals, interpreted as clamps, due resisting the movement (distortion) of the chest tube in relation to the insertion device. Further, per paragraph 0070, Hart teaches that the seals provide strict requirements regarding friction, drag, and durability. Therefore as the seals provide friction to the instrument (as the instrument passes through the seals) it is interpreted that the friction provides at least some resistance in movement of the instrument.
Claim(s) 9-12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathis in view of Hart, Aho, Karpiel and Lazarus, and further in view of Dubrul US 5454790, hereafter Dubrul.
Regarding claim 9, Mathis, Hart, Aho, Karpiel, and Lazarus teach
The method of claim 8, wherein the sheath further comprises: a collar positioned at the proximal end of the sheath body; a first handle disposed on the collar; and a second handle disposed on the collar opposite the first handle. The examiner notes that although the previously described figure 4 of Mathis does not have explicit disclosure of a sheath collar, Mathis figure 8 discloses a control mechanism for the sheath comprising a sheath knob (614), seen to comprise opposite outwardly extending portions configured to be gripped and thus rotating the knob (para. 0120). Therefore it would have been obvious to modify the proximal end of the device of figure 4 to comprise the sheath knob to allow for rotational control of the device.
Should applicant disagree with this interpretation, a secondary rejection is provided in view of Dubrul.
Dubrul teaches a catheterization access device and is thus considered analogous to the claimed invention. Dubrul teaches that the device comprises an outer sleeve assembly (Fig. 19 (114)) comprising handle (134), where said handle is interpreted to be two separate handles due to the splitting line (136) separating the handles. Further, per column 8, lines 35-40, the handle is splitable and is thus interpreted as two handles at the proximal end of the sheath. The first handle is interpreted as the left handle (from the figure) and the second handle is interpreted as the right handle. Per column 8, lines 35-40, the handles are preferably splitable to allow the outer sheath to be easily removable. Therefore, as it was found obvious to one having ordinary skill in the art prior to the effective filing date, under the rejection of claim 8, to provide Mathis with a splitable, removable outer sheath, it would have further been obvious to one having ordinary skill in the art to provide the splitable line through the handles to further facilitate removal of the device.
Regarding claim 10, Mathis, Hart, Aho, Karpiel, Lazarus and Dubrul teach
The method of claim 9, wherein positioning the chest tube insertion apparatus includes rotating the chest tube insertion apparatus inside the pleural opening via the first handle and the second handle positioned on the proximal end of the sheath body. The examiner notes that as detailed under the rejection of claim 9, Mathis discloses an outer sheath knob for rotating the device, and thus reads to the claimed limitation.
Regarding claim 11, Mathis, Hart, Aho, Karpiel, Lazarus and Dubrul teach
The method of claim 10, wherein the chest tube insertion apparatus further comprises a first fracture line and a second fracture line, wherein the first fracture line is a first groove on the sheath body extending from the distal end to the proximal end of the sheath body, and the second fracture line is a second groove on the sheath body extending from the distal end to the proximal end of the sheath body. The examiner notes that as detailed under the rejection of claim 8, per column 4, lines 14-20, the device of Karpiel is disclosed to have two longitudinal grooves cut into the outer surface of the catheter (column 1 of Karpiel, lines 14-20) to facilitate the removal of said catheter (sheath) without disturbing the placement of the guidewire (or other inserted material column 1 of Karpiel, lines 14-20). Per the rejection of claim 8, it was found obvious to combine said teachings with the device of Mathis.
Regarding claim 12, Mathis, Hart, Aho, Karpiel, Lazarus and Dubrul teach
The method of claim 11, wherein the tapered tube clamp of the chest tube insertion apparatus further comprises one or more clamp tabs angled radially inward toward the distal end opening and operable to provide resistance to axial movement of the chest tube relative to the chest tube insertion device. Per the claim 8 rejection of Mathis in view of Hart, it was found obvious to modify the distal end opening of Mathis to comprise a taper and duckbill seals to prevent backflow. As seen in figures 6, 7, and 8 of Hart, these seals are plural ((120 and 140) disclosed per para. 0064 as duckbill seals) and are interpreted and angled radially inward as seen in said figures, due to the inward caving of said seals, and are further interpreted to be angled toward a distal end, as said seals can be seen extending toward or along the distal opening (figure 6). The examiner notes that this inward extension, best seen in figure 6 shows the seals extending inward away from the sheath wall, and forming an orifice (145). Therefore as the seals can be seen extending away from and off of the wall, it is interpreted that the seals are extending free of the sheath body relative to a first ( interpreted as the longitudinal axis of the device).
Regarding claim 14, Mathis, Hart, Aho, Karpiel, Lazarus and Dubrul teach
The method of claim 11, further comprising separating the sheath from the chest tube by splitting the sheath body along the first and second fracture lines and removing sheath body. The examiner notes that as detailed under the rejection of claim 8, per column 4, lines 14-20, the device of Karpiel is disclosed to have two longitudinal grooves cut into the outer surface of the catheter (column 1 of Karpiel, lines 14-20) to facilitate the removal of said catheter (sheath) without disturbing the placement of the guidewire (or other inserted material column 1 of Karpiel, lines 14-20). Per the rejection of claim 8, it was found obvious to combine said teachings with the device of Mathis.
Regarding claim 20, Mathis, Hart, Aho, Karpiel, Lazarus and Dubrul teach
The method of claim 12, wherein each of the plurality of clamp tabs are separated from each other, prior to insertion of the chest tube past the distal end of the sheath body, by a clamp tab gap (Hart para. 0065, figure 9). The examiner notes that as detailed under the rejection of claim 8, the seals of Hart are duckbill valves and are interpreted to be the clamps. The examiner notes that as seen in the figures (6-10) said duckbill valve comprises slits (130 figure 9-10, see also figures 32-33), interpreted to be gaps between the tabs of the valve (tabs interpreted as being the sections on each side of the slit). Per figures 9-10 said slits are seen to overlap with the opening (145) through which an instrument is extended through for treatment. As such it is interpreted that the instrument would pass through said slits. Per paragraph 0065, when an instrument is placed through the lumen, deformation of the seals (interpreted clamps) occurs to allow the instrument to pass through. As such, it is interpreted that the seals are flexible, based on their ability to deform to structures passing through them. Therefore, as the seals comprise gaps to aid in their sealing function, where said seals are flexible when receiving an instrument through them, it is interpreted that the structure of Hart, found obvious to combine under the rejection of claim 8 would read to the claimed invention.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mathis in view of Hart, Aho, Karpiel, Lazarus, Dubrul, and further in view of To US 2011/0098531, hereafter TO.
Regarding claim 13, Mathis, Hart, Aho, Karpiel, Lazarus and Dubrul teach
The method of claim 12, but fails to specifically teach the method further comprising obtaining a portable chest X-ray.
TO teaches a cannula accessing system and is thus considered analogous to the claimed invention. TO teaches, per paragraph 0126, that the device may be used with various chest related procedures, where later, the cannula may be removed and an x-ray may be taken to check for a pneumothorax. Based on the x-ray a determination is made is chest tube drainage may be required. Therefore as TO teaches that x-rays may be used in combination with chest drainage operations to determine treatment progress, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide a step of acquiring an x-ray to determine treatment progress in the method Mathis Hart, Aho, Karpiel, Lazarus and Dubrul.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781