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 .
Response to Arguments
The drawings were received on 4/29/2026. These drawings are unacceptable due to shading in schematic figures that are not photographs. See drawings objection below.
The previous objection of claims 1, 2 and 4 due to minor informalities has been withdrawn in light of applicant’s amendments made 4/29/2026. Some claim objections remain with respect to claims 13-14, as discussed below.
The previous rejection of claim(s) 1-2 and 4-20 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 1-2, 6, 8 and 18 on 4/29/2026.
The rejection of claims 1-5, 7-9, 14 and 20 under 35 U.S.C. 102(a)(1) as being anticipated by Breznock (US 2006/0206097) has been withdrawn in light of applicant’s amendment made 4/29/2026. Specifically, Breznock does not teach a flange that is permanently fixedly attached to an outer surface of the chest tube at a predetermined position prior to insertion of the distal end of the chest tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the chest tube during insertion.
Applicant’s arguments with respect to claims 1-3, 6, 11, 13 and 15-19 and the permanent fixation of the flange of Breznock have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Moy (5,509,909) in view of Slager et al. (US 2017/0072129 A1) teaches said limitation.
Applicant’s arguments with respect to claim(s) 9, 10, 14 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to because: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. This applies to shading. Solid black shading areas are not permitted, expect when used to represent bar graphs or color. See for example, Figures 1A, 1C, 2A-2B, 3-4, 6-9, 11-13, 14A-14C, 15-16, 17A-17B, 18A-18C, 19-30, 31A-31B and 32.
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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “a patient” in line 12 which should read “the patient” for consistency purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the distal end of the stylet” in lines 17-18 which should read “a distal end of the stylet”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Claim 2 recites “a patient” in line 13 which should read “the patient” for consistency purposes. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Claim 1 recites “the distal end of the stylet” in lines 18-19 which should read “a distal end of the stylet”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “at the edges thereof” in line 2. While it is inherent the handle has edges, applicant is requested to amend the claim to read “at edges thereof” for consistency purposes. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites “the distal stylet tip” in line 2 which should read “the distal tip of the stylet” for consistency purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “the hollow lumen configured to receive a guidewire for Seldinger technique deployment” in lines 2-3. While applicant does have support for a stylet 236 with a hollow lumen 237 running along its entire length to allow the chest tube device 200 to be deployed using a guidewire as a measure of added safety when the anatomy and/or habitus make initial placement questionable ([0104]), the specification is silent to “Seldinger” technique deployment. Accordingly, the claim(s) contains subject matter which was not described in the specification.
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) 1-3, 5-9 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1).
Regarding claim 1, Moy discloses a chest tube device (chest tube assembly 10; Fig. 1), comprising: a chest tube (elongate catheter 12) having a proximal end (proximal portion 16) of the chest tube and a distal end (distal portion 18) of the chest tube (Fig. 1), and a lumen (lumen through 12; Fig. 1) extending therethrough, the proximal end of the chest tube having an opening with a diameter larger than a diameter of the lumen (as opening at the proximal end of the lumen is larger than the distal end due to stop 37; Fig. 2) and the distal end of the chest tube having a tapered tip (at beveled surface 24); a flange (clamp assembly 44) having an aperture (opening of 44; Fig. 5) with an inner diameter equal to an outer diameter of the chest tube (as the inner diameter 46 is constructed and arranged to surround and clam to the outer diameter of the catheter 12; Fig. 3) to limit insertion of the chest tube during insertion of the chest tube device (Fig. 3), the flange having at least one cutout (bores 58) configured to receive a strap (suture) to fix the chest tube device to the patient (as the clamp assembly 44 can be sutured to the skin via bores 58; column 4, lines 39-41); and a stylet (trocar 14) comprising a handle (proximal end of 14) and a shaft (portion of 14 distal to stop surface 39 and proximal trocar tip 26; Figs. 2-3, 4) extending distally from the handle (Fig. 1), the shaft having a distal tip (trocar tip 26), wherein the shaft has a diameter smaller than the diameter of the lumen of the chest tube (as the portion of trocar 14 distal to stop surface 39 extends through the lumen; Figs. 1-3); wherein the stylet is slidably movable through the chest tube such that a distal end of the stylet protrudes from the distal end of the chest tube (Figs. 1-3), and the handle of the stylet is proximal to the proximal end of the chest tube (Fig. 1).
Moy discloses the flange is permanently fixedly attached to an outer surface of the chest tube at a predetermined position (through snaping protrusion 52 through bore 54; column 4, lines 28-41) but fails to explicitly disclose permanently fixing the flange prior to insertion of the distal end of the chest tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the chest tube during insertion.
However, Slager teaches a flange (fixation structure 225) permanently fixedly attached to an outer surface of a tube (sleeve 110) at a predetermined position prior to insertion of the distal end of the tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the tube during insertion (as the fixation structure 225 may be integral with or coupled to the tube assembly; [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange of Moy to be integral with the chest tube rather than coupled thereto as taught by Slager, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 2, Moy discloses a chest tube device (chest tube assembly 10; Fig. 1), comprising: a chest tube (elongate catheter 12) having a proximal end (proximal portion 16) of the chest tube and a distal end (distal portion 18) of the chest tube (Fig. 1), and a lumen (lumen through 12; Fig. 1) extending therethrough, the proximal end of the chest tube having an opening with a diameter larger than a diameter of the lumen (as opening at the proximal end of the lumen is larger than the distal end due to stop 37; Fig. 2) and the distal end of the chest tube having a tapered tip (at beveled surface 24), the chest tube (12) including a plurality of fenestrations (spaced drainage holes 32) disposed about the distal end of the chest tube (Fig. 1); a flange (clamp assembly 44), proximal of the plurality of fenestrations (Fig. 3), the flange (44) including at least one sidewall extending perpendicularly outward (at least at segments 56) from the chest tube (12) to limit insertion of the chest tube during insertion of the chest tube device (Fig. 3), the flange (44) having at least one cutout (bores 58) configured to receive a strap (suture) to fix the chest tube device to the patient (as the clamp assembly 44 can be sutured to the skin via bores 58; column 4, lines 39-41); and a removable stylet (trocar 14) comprising a handle (proximal end of 14) and a shaft (portion of 14 distal to stop surface 39 and proximal trocar tip 26; Figs. 2-3, 4) extending distally from the handle (Fig. 1), the shaft having a distal tip (trocar tip 26), wherein the shaft has a diameter smaller than the diameter of the lumen of the chest tube (as the portion of trocar 14 distal to stop surface 39 extends through the lumen; Figs. 1-3); wherein the stylet (14) is slidably movable through the chest tube such that a distal end of the stylet protrudes from the distal end of the chest tube (Figs. 1-3), and the handle of the stylet is proximal to the proximal end of the chest tube (Fig. 1).
Moy discloses the flange is permanently fixedly attached to an outer surface of the chest tube at a predetermined position (through snaping protrusion 52 through bore 54; column 4, lines 28-41) but fails to explicitly disclose permanently fixing the flange prior to insertion of the distal end of the chest tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the chest tube during insertion.
However, Slager teaches a flange (fixation structure 225) permanently fixedly attached to an outer surface of a tube (sleeve 110) at a predetermined position prior to insertion of the distal end of the tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the tube during insertion (as the fixation structure 225 may be integral with or coupled to the tube assembly; [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange of Moy to be integral with the chest tube rather than coupled thereto as taught by Slager, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 3, Moy discloses a chest tube device (chest tube assembly 10; Fig. 1), comprising: a chest tube (elongate catheter 12) having a lumen (lumen through 12) extending therethrough from a proximal end (proximal portion 16) of the chest tube to a distal end (distal portion 18) of the chest tube (Fig. 1), said chest tube (12) including a flange (clamp assembly 44) permanently fixedly attached to the chest tube at a predetermined position between the proximal end of the chest tube and the distal end of the chest tube (through snaping protrusion 52 through bore 54; column 4, lines 28-41), to limit insertion of the chest tube into a patient's body during insertion (Fig. 3); and a stylet (trocar 14) having a handle (proximal end of 14) and a shaft (portion of 14 distal to stop surface 39 and proximal trocar tip 26; Figs. 2-3, 4), said shaft having a proximal end connected to the handle and a free opposite distal end having a tip (trocar tip 26), wherein the shaft of the stylet is slidably positioned in the lumen of the chest tube with the tip protruding from the distal end of the chest tube to facilitate insertion of the chest tube into the patient's body (Figs. 1-3), wherein the stylet is removable from the chest tube after deployment (column 4, lines 26-27).
Moy discloses the flange is permanently fixedly attached to an outer surface of the chest tube at a predetermined position (through snaping protrusion 52 through bore 54; column 4, lines 28-41) but fails to explicitly disclose permanently fixing the flange prior to insertion of the distal end of the chest tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the chest tube during insertion.
However, Slager teaches a flange (fixation structure 225) permanently fixedly attached to an outer surface of a tube (sleeve 110) at a predetermined position prior to insertion of the distal end of the tube into a patient such that the flange is not user-adjustable, repositionable, or slidable along the tube during insertion (as the fixation structure 225 may be integral with or coupled to the tube assembly; [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange of Moy to be integral with the chest tube rather than coupled thereto as taught by Slager, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 5, Moy modified fails to explicitly disclose wherein the flange is located 8 to 10 cm from the distal end of the chest tube.
However, Moy teaches that the flange (44) is located approximately at the third inch mark of indicia (28) which is approximately 7 cm (Fig. 3; column 3, lines 6-10, 30-32) from the distal end of the chest tube, which is approaching and similar in range to the claimed 8 to 10 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the flange of modified Moy to be located 8 to 10 cm from the distal end of the chest tube as applicant appears to have placed no criticality on the claimed range (see [0062] indicating the flange is “approximately” within the claimed range) and since it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997).
Regarding claim 6, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the at least one cutout (58) comprises a plurality of cutouts (Fig. 5) for attachment of the strap (suture) to secure the chest tube to the patient's body (as the clamp assembly 44 can be sutured to the skin via bores 58; column 4, lines 39-41).
Regarding claim 7, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the chest tube (12) includes one or more fenestrations (drainage holes 32) between the flange (44) and the distal end of the chest tube (12) for egress of fluids (Fig. 1; column 3, lines 25-27).
Regarding claim 8, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the plurality of fenestrations (32) include a proximal hole 6 cm away from the flange (44) toward the distal end of the chest tube (as the drainage holes 32 extend from the open distal end 22 to approximately the two inch indicia mark on the catheter where the clamp assembly 44 lies i.e., 7 cm; thus, holes 32 are placed 6 cm distally of clamp assembly 44; Fig. 3; column 3, lines 6-10, 30-32).
Regarding claim 9, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the chest tube (12) includes a visually discernible marker strip (radio-opaque line 34) disposed along a back or spine (along the concave surface of the catheter 12) of the chest tube to identify tube curvature (column 3, lines 36-42).
Regarding claim 19, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the chest tube (12) has a right-angle shape (Figs. 1, 3; column 3, lines 15-18).
Regarding claim 20, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the marker strip (34) is radiopaque (radio-opaque line 34; column 3, lines 36-42).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1), as applied to claim 1 above, and further in view of Victor (US 4,636,199).
Regarding claim 4, Moy modified discloses the invention as claimed above, and Moy further discloses wherein suction may be applied to the open distal end of the chest tube (12) to produce required suction evacuation (column 4, lines 42-44), but Moy fails to disclose the proximal end of the chest tube is flared to facilitate insertion of an adapter for a suction device.
However, Victor teaches a chest tube (catheter 34; Figs. 1-3) with a flared (flared at 32) proximal end (Fig. 3) to facilitate insertion of an adapter for a device (trocar 26) for the purpose of preventing further insertion of the device through the chest tube (column 3, lines 3-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the chest tube of modified Moy to be flared as taught by Victor in order to facilitate insertion of an adaptor for a device such that the device is prevented from being inserted too far through the chest tube.
Claim(s) 10, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1), as applied to claim 1 above, and further in view of Burchette, Jr. (US 5,057,082).
Regarding claims 10 and 14, Moy modified discloses the invention as claimed above, and Moy further discloses wherein the distal tip (26) of the stylet (14) may be constructed in any desired configuration suitable for piercing tissue (column 3, lines 56-57), but fails to disclose wherein the distal tip of the stylet comprises an upper beveled edge and an underlying sharpened edge, the distal tip defining a combined wedge design, wherein the upper beveled edge is configured to deflect tissue away from the distal stylet tip during insertion, and the underlying sharpened edge is configured to cut through tissue during insertion to facilitate entry.
However, Burchette, Jr. teaches a stylet (trocar 16; Figs. 1-3) comprising a handle (knob-type handle 20) and a shaft (main shank portion 18) having a distal tip (piercing and cutting end 22) comprising an upper beveled edge (face 28) and an underlying sharpened edge (cutting edge 36), the distal tip (22) defining a combined wedge design (Figs. 1-3), wherein the upper beveled edge (28) is configured to deflect tissue away from the distal stylet tip during insertion (due to the beveled shape of the face 28), and the underlying sharpened edge (36) is configured to cut through tissue during insertion to facilitate entry (as 36 is a cutting edge).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip of the stylet of modified Moy to have an upper beveled edge and underlying sharpened edge as claimed as taught by Burchette, Jr. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of cutting and piercing tissue.
Regarding claim 16, Moy modified fails to disclose wherein the handle of the stylet includes a flat end to facilitate hammering.
However, Burchette, Jr. teaches a stylet (trocar 16; Figs. 1-3) comprising a handle (knob-type handle 20) having a flat end (outer surface 24; Figs. 1-2) capable of being hammered and a shaft (main shank portion 18) having a distal tip (piercing and cutting end 22)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of the stylet of modified Moy to be flat as taught by Burchette, Jr. since changing the shape of the claimed handle is a matter of choice when a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed handle is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed (i.e. a handle with a flat end) by known methods with no change in their respective functions, and the combination would have yielded the predictable result of a handle that may be manually gripped and actuated by a user.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1), as applied to claim 1 above, and further in view of Dewey et al. (US 2022/0346844 A1).
Regarding claims 11 and 13, Moy modified fails to disclose wherein the handle of the stylet has a raised undulating profile, and/or wherein an end of the handle proximate the shaft is flat and curved inward at edges thereof to engage and accommodate the proximal end of the chest tube.
However, Dewey teaches a stylet (surgical verification instrument 34; Fig. 1) having a shaft (body 38) and a handle (handle 50) at the proximal end of the shaft (Fig. 1), the medical device insertable within a tube (surgical inserter 12; Figs. 1-2), wherein the handle (50) may include an end of the handle proximate the shaft that is flat (see upper portion of 50 in Fig. 1) and curved inward at edges thereof (cylindrical portions around flat portion; Fig. 1) to engage in and accommodate the proximal end of the tube (12; Figs. 1-2), and/or wherein the handle (50) of the stylet has a raised undulating profile (as handle 50 may include alternate surface configuration to enhance gripping, including undulating, dimpled and/or textured i.e., knurled; [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of the stylet of modified Moy to have any one of a raised undulating profile, knurled with finger grooves, and/or wherein an end of the handle proximate the shaft is flat and curved inward at edges thereof to engage in and accommodate the proximal end of the chest tube in light of the teachings of Dewey in order to enhance gripping of the handle.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1), as applied to claim 1 above, and further in view of Navis (US 2015/0087914 A1).
Regarding claim 15, Moy modified fails to disclose wherein the handle of the stylet includes an eyelet for attaching a strap or cord.
However, Navis teaches a stylet (trocar 66) comprising a handle (knob 51 and strap 31; Fig. 3), the stylet insertable through a tube (guide 11), wherein the handle (51, 31) of the stylet (66) includes an eyelet (slot 46) for attaching strap or cord (elongated tab 26; Fig. 3) of a shaft (14) of the tube (11) in order to help secure the stylet relative to the tube ([0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of the stylet of modified Moy to include a strap including an eyelet as taught by Navis in order to secure the stylet relative to the chest tube.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1), as applied to claim 1 above, and further in view of Alley et al. (US 3,459,189) in view of Kenealy, III et al. (US 2006/0085005 A1).
Regarding claims 17-18, Moy modified fails to disclose wherein the shaft of the stylet includes ruler markings, wherein the markings are phosphorescent for use in low-light conditions.
However, Alley teaches a chest tube device (thoracic trocar catheter; column 1, lines 37-38; Figs. 1-5), comprising: a chest tube (catheter tube 30), a stylet (trocar 10) having a shaft (shaft portion 11), wherein the stylet is slidably movable through the chest tube such that a distal end of the stylet protrudes from a distal end of the chest tube (Figs. 4-5), wherein the shaft (11) of the stylet (10) includes at least one marking (mark 21; Fig. 1) to form a measuring stick and record a depth of insertion (column 4, lines 42-57).
Kenealy, III teaches a medical stylet (drill bit 42 for producing bores in bone tissue; [0018]) with a plurality of ruler markings (depth markers 54; Fig. 4) that are phosphorescent for use in low-light conditions ([0040]; [0047]) in order to enhance the visibility of the markers by causing phosphorescence to occur and phosphorescent depth markings continue to emit light even when UV light is not be applied ([0040]; [0047]). The plurality of ruler markings (54) indicate a length from a distal end of the stylet ([0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a shaft of the stylet of modified Moy to include phosphorescent ruler markings in light of the teachings of Alley and Kenealy, III in order to indicate a depth of insertion of the stylet with enhanced visibility even when UV light is not applied.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 5,509,909) in view of Slager et al. (US 2017/0072129 A1), as applied to claim 1 above, and further in view of DeFonzo et al. (US 9,867,926 B2).
Regarding claim 21, Moy modified fails to disclose wherein the shaft of the stylet comprises a hollow lumen extending therethrough from the handle to the distal tip, the hollow lumen configured to receive a guidewire for Seldinger technique deployment.
However, DeFonzo teaches a stylet (trocar 300; Fig. 22) comprising a handle (handle 308) and a shaft extending distally from the handle (Fig. 22), the shaft having a distal tip (distal tip 302), wherein the shaft of the stylet (300) comprises a hollow lumen (lumen 304) extending therethrough from the handle to the distal tip (Fig. 22), the hollow lumen (304) configured to receive a guidewire (Fig. 29A) capable of Seldinger technique deployment (column 8, lines 14-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of the stylet of modified Moy to include a hollow lumen as taught by DeFonzo in order to allow the stylet to be inserted over a guidewire, thereby improving accuracy of deployment of the chest tube device.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights