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 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 “the circular flange” in line 7 which should read “the flange” for consistency purposes. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Claim 2 recites “the tube” in line 5 which should read “the chest tube” for consistency purposes. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Claim 4 recites “for suction device” in line 2 which should read “for a suction device” for grammatical purposes. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “where in the end of the handle” in lines 1-2 and “curved in word at the edges thereof to engage in accommodate” in lines 2-3. While it is inherent the handle has ends and edges, applicant is requested to maintain consistency and correct grammatical mistakes. For example, to read “wherein an end of the handle…covered inward at edges thereof to engage in and accommodate”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites “the tip” in line 1 which should read “the beveled tip”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the proximal end” in line 9. It is unclear if this refers to the previously recited proximal end of the chest tube or the previously recited proximal end of the stylet.
Claim 1 recites “the distal end” in line 10. It is unclear if this refers to the previously recited proximal end of the chest tube or the previously recited proximal end of the stylet.
Claim 1 recites “a diameter of the lumen of the chest tube” in line 11. It is unclear if this refers to the previously recited diameter of the lumen in line 3 or a different diameter.
Claim 2 recites “the proximal end” in line 10. It is unclear if this refers to the previously recited proximal end of the chest tube or the previously recited proximal end of the stylet.
Claim 2 recites “the distal end” in line 11. It is unclear if this refers to the previously recited proximal end of the chest tube or the previously recited proximal end of the stylet.
Claim 2 recites “a diameter of the lumen of the chest tube” in line 11. It is unclear if this refers to the previously recited diameter of the lumen in line 3 or a different diameter.
Claim 6 recites “the flange includes cutouts” in lines 1-2. It is unclear if these cutouts refer to the previously recited “at least one cutout” of claim 1, line 7 or are in addition thereto.
Claim 8 recites the limitation "the one or more fenestrations" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the shaft" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the shaft" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the markings" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-5, 7, 9-12, 14-16 and 19-20 are rejected based on their dependency on rejected claim 1.
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.
Claim(s) 1-5, 7-9, 14 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breznock et al. (US 2006/0206097 A1).
Regarding claim 1, Breznock discloses a chest tube device (Figs. 1-3B), comprising: a chest tube (cannula, tube or catheter 10; Fig. 1) having a proximal end (towards hub 12) and a distal end (towards holes 20; Fig. 1), and a lumen (drainage lumen 32; Figs. 1-2) extending therethrough, the proximal end having an opening (opening of valve housing 15) with a diameter larger than a diameter of the lumen (as the valve 14 has a diameter larger than the outer diameter of tubing 22 through which the lumen 32 extends; Fig. 1) and the distal end having a tapered tip (tapered tip of 22 distal of holes 20; Fig. 1); a circular flange (extracorporeal fixation device 16 which is at least circular around the opening that fits over the tubing 22) having an inner diameter equal to an outer diameter of the chest tube (Fig. 1), the flange (16) positioned on the chest tube to limit insertion of the chest tube during deployment of the chest tube device (as 16 forcibly stops sliding, preventing the chest drainage tube 10 from inadvertently being pushed farther in the patient’s chest; [0044]), the circular flange having at least one cutout (hole) configured to receive a strap (suture) to fix the chest tube device to a patient (as 16 optionally comprises a hole located somewhere on its structure, through which suture may be passed to facilitate attachment to the patient’s skin; [0048]); and a stylet (trocar 40; Fig. 3A) having a proximal end and a distal end (Fig. 3A), the proximal end having a handle (plunger 42) for a user to grip during deployment, the distal end having a beveled tip (pointed tip or needle 46; Fig. 3A), the stylet (40) further having a diameter smaller than a diameter of the lumen of the chest tube (as 40 is inserted within 10; Fig. 3B); wherein the stylet (40) is slidably movable through the chest tube (10) such that the distal end of the stylet protrudes from the distal end of the chest tube (Fig. 3B; [0039]), and the handle (42) of the stylet (40) is proximal to the proximal end of the chest tube (10; Fig. 3B).
Regarding claim 2, Breznock discloses a chest tube device (Figs. 1-3B), comprising: a chest tube (cannula, tube or catheter 10; Fig. 1) having a proximal end (towards hub 12) and a distal end (towards holes 20; Fig. 1), and a lumen (drainage lumen 32; Figs. 1-2) extending therethrough, the proximal end having an opening (opening of valve housing 15) with a diameter larger than a diameter of the lumen (as the valve 14 has a diameter larger than the outer diameter of tubing 22 through which the lumen 32 extends; Fig. 1) and the distal end having a tapered tip (tapered tip of 22 distal of holes 20; Fig. 1), the chest tube (10) including a plurality of fenestrations (drainage holes 20) disposed about the distal end of the chest tube (Fig. 1); a flange (extracorporeal fixation device 16) disposed on an outer surface of the chest tube and proximal of the plurality of fenestrations (Fig. 1), the flange (16) including at least one sidewall (upper or lower surface of 16) extending perpendicularly outward from the chest tube (Fig. 1) to limit insertion of the chest tube during deployment of the chest tube device (as 16 forcibly stops sliding, preventing the chest drainage tube 10 from inadvertently being pushed farther in the patient’s chest; [0044]), the flange having at least one cutout (hole) configured to receive a strap (suture) to fix the chest tube device to a patient (as 16 optionally comprises a hole located somewhere on its structure, through which suture may be passed to facilitate attachment to the patient’s skin; [0048]); and a removable stylet (trocar 40; Fig. 3A) having a proximal end and a distal end (Fig. 3A), the proximal end having a handle (plunger 42), the distal end having a beveled tip (pointed tip or needle 46; Fig. 3A), the stylet (40) further having a diameter smaller than a diameter of the lumen of the chest tube (as 40 is inserted within 10; Fig. 3B); wherein the stylet (40) is slidably movable through the chest tube (10) such that the distal end of the stylet protrudes from the distal end of the chest tube (Fig. 3B; [0039]), and the handle (42) of the stylet (40) is proximal to the proximal end of the chest tube (Fig. 3B).
Regarding claim 3, Breznock discloses a chest tube device (Figs. 1-3B), comprising: a chest tube (cannula, tube or catheter 10; Fig. 1) having a lumen (drainage lumen 32; Figs. 1-2) extending therethrough from a proximal end (towards hub 12) of the chest tube (10) to a distal end (towards holes 20; Fig. 1) of the chest tube, said chest tube including a flange (extracorporeal fixation device 16) between the proximal end and the distal end (Fig. 1) to limit insertion of the chest tube into a patient's body during deployment (as 16 forcibly stops sliding, preventing the chest drainage tube 10 from inadvertently being pushed farther in the patient’s chest; [0044]); and a stylet (trocar 40; Fig. 3A) having a handle (plunger 42) and a shaft (body 44), said shaft (44) having a proximal end connected to the handle (Fig. 3A) and a free opposite distal end having a beveled tip (pointed tip or needle 46; Fig. 3A), wherein the shaft (44) of the stylet (40) is slidably positioned in the lumen (32) of the chest tube (10) with the beveled tip (46) protruding from the distal end of the chest tube to facilitate insertion of the chest tube into the patient's body (Fig. 3B; [0039]), wherein the stylet is removable from the chest tube after deployment (after medical personnel push the plunger 42 to force the needle 46 into the thoracic cavity into the pleural cavity, the trocar 40 is removed and the chest drainage tube 10 is in place; [0039]).
Regarding claim 4, Breznock discloses wherein the proximal end of the chest tube (10) is flared (at fittings 28, 26) to facilitate insertion of an adapter for suction device (as adapter or fitting 26 may be connected to a vacuum system; [0052]).
Regarding claim 5, Breznock discloses wherein the flange (16) is located 8 to 10 cm from the distal end of the chest tube (10; as intracorporeal fixation balloon 18 may be located 5 cm to 20 cm from the most distal drainage hole 20 and extracorporeal fixation device 16 is slidably located on the outside of the tubing 22 proximal the intracorporeal fixation balloon 18; [0035]).
Regarding claim 7, Breznock discloses wherein the chest tube (10) includes one or more fenestrations (holes 20) between the flange (16) and the distal end of the chest tube for egress of fluids (Fig. 1; [0034]).
Regarding claim 8, Breznock discloses the one or more fenestrations (20) include a proximal hole 6 cm away from the flange (16) towards the distal end of the chest tube (10; as intracorporeal fixation balloon 18 may be located 2 cm to 40 cm from the most distal drainage hole 20 and extracorporeal fixation device 16 is slidably located on the outside of the tubing 22 proximal the intracorporeal fixation balloon 18; [0035]).
Regarding claim 9, Breznock discloses wherein the chest tube (10) comprises a flexible inert silicone elastomer material (as balloons 14 of the valve of the cannula 10 are made of a silicone elastomer; [0053]).
Regarding claim 14, Breznock discloses wherein the tip (46) of the stylet has a triangular shape (Fig. 3A).
Regarding claim 20, Breznock discloses wherein the chest tube (10) includes a radio-opaque marker to identify tube curvature (as the balloon 18 of cannula 10 may be inflated with a radiopaque media; [0037]).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock et al. (US 2006/0206097 A1).
Regarding claim 6, Breznock discloses wherein the flange includes at least one cutout (hole) for attachment of a strap (suture) to secure the chest tube to the patient's body (as 16 optionally comprises a hole located somewhere on its structure, through which suture may be passed to facilitate attachment to the patient’s skin; [0048]), but fails to explicitly disclose a plurality of cutouts.
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 Breznock to include a plurality of cutouts since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock et al. (US 2006/0206097 A1) in view of Okada (US 2007/0078438 A1).
Regarding claim 10, Breznock fails to disclose wherein the stylet comprises a high density polyethylene material.
However, Okada teaches a stylet (stylet 16) that is preferably made of a strong and hard material such as high-density polyethylene ([0055]).
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 stylet of Breznock to comprise a high density polyethylene material as taught by Okada in order to make the stylet of a strong and hard material.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock et al. (US 2006/0206097 A1) in view of Dewey et al. (US 2022/0346844 A1).
Regarding claims 11-13, Breznock fails to disclose wherein the handle of the stylet has a raised undulating profile, wherein the handle of the stylet is 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.
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, wherein the handle of the stylet is knurled with finger grooves (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 Breznock 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 Breznock et al. (US 2006/0206097 A1) in view of Navis (US 2015/0087914 A1).
Regarding claim 15, Breznock 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 Breznock to include the strap including an eyelet as taught by Navis in order to secure the stylet relative to the chest tube.
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock et al. (US 2006/0206097 A1) in view of Raza (US 2021/0128194 A1).
Regarding claim 16, Breznock fails to disclose wherein the handle of the stylet includes a flat end to facilitate hammering.
However, Raza teaches a chest tube device (Fig. 1) comprising a chest tube (shaft 102) and a stylet (obturator 106) slidably movable through the chest tube such that a distal end (112) of the stylet (106) protrudes from a distal end of the chest tube (Fig. 1), and a handle (outer flange 108) of the stylet (106) is proximal to the proximal end of the chest tube and wherein the handle includes a flat end (108).
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 Breznock to be flat as taught by Raza 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.
Regarding claim 19, Breznock fails to disclose wherein the chest tube has a right angle shape.
However, Raza teaches a chest tube device (Fig. 1) comprising a chest tube (shaft 102) and a stylet (obturator 106) slidably movable through the chest tube such that a distal end (112) of the stylet (106) protrudes from a distal end of the chest tube (Fig. 1), and a handle (outer flange 108) of the stylet (106) is proximal to the proximal end of the chest tube and wherein the chest tube (102) has a right angle shape (as the tubular shaft 102 may be curved as shown in Figs. 1-2 or L-shaped, and an L-shape includes a right angle; [0023]) in order to align the gripping mechanism (handle 104) of the chest tube when positioning the chest tube into the pleural cavity ([0023]).
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 chest tube of Breznock to have a right angle shape as taught by Raza in order to allow for easier positioning/gripping of the chest tube during insertion and positioning into the pleural cavity.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock et al. (US 2006/0206097 A1) 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, Breznock 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 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 Breznock to include phosphorescent ruler markings in light of the teachings of Alley and Kenealy in order to indicate a depth of insertion of the stylet with enhanced visibility even when UV light is not applied.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Victor (US 4,636,199) is noted for a chest tube with a flared proximal end.
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.
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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.
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/SARAH A LONG/Primary Examiner, Art Unit 3771