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 Amendment
As of the preliminary amendment filed 4/24/2025, the specification has been amended. No new matter has been added.
Specification
The disclosure is objected to because of the following informalities:
PPs [0044] and [0056] of the present specification do not include any text. It is recommended that these paragraphs be deleted and that the numbering for subsequent paragraphs be adjusted in order to accurately reflect their deletion.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by James (US Patent No. 5,279,551).
Regarding claim 1, James discloses a chest tube inserter (11 in Fig. 1) for inserting a chest tube (col. 3, lines 62-63: “Catheter tube 11 includes a first lumen 17 which is formed by central bore 19 of tube 11”, central bore 19 is configured for conveying a chest tube), which is provided to penetrate a chest wall (11 is configured to penetrate a chest wall, col. 3, lines 43-45: “a catheter device 10 generally is of appropriate size and shape for use in the treatment of the pleural space”),
wherein a body part of the chest tube inserter (11) has an insert guide hole (central bore 19, see col. 3, lines 62-63 as cited above) formed therethrough so that a chest tube is inserted therein (central bore 19 is configured for conveying a chest tube, the chest tube is only claimed as the object of functional language so the claim is being interpreted to require only a chest tube inserter configured to enable the insertion of a chest tube, and to not require a chest tube itself, see MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”).
Regarding claim 2, James further discloses wherein the body part (body of 11 in Fig. 1, see also Figs. 6-11 for cross-sectional views) has an outer skin formed therein (outer surface of 11 in Fig. 6) to surround an inner skin (inner surface of 17) that forms the inner guide hole (19, col. 3, lines 62-63: “Catheter tube 11 includes a first lumen 17 which is formed by central bore 19 of tube 11”), and a drug receiving part (35) is provided between the inner skin and the outer skin (see Fig. 6, 35 is located radially within the outer surface of 11 but radially outside of the central bore 19).
Regarding claim 3, James further discloses wherein a drug injection port (43 in Fig. 6, col. 4, lines 33-37: “This injection port 45 is of conventional design, such as those known as heparin lock ports, and is used for injection of drugs, antibiotics, antiseptic and anesthetic fluids, irrigation fluids and the like as needed in the pleural cavity”) is formed on a rear side of the body part (body of 11, 43 is formed on a more proximal/leftward end of 11), and a drug discharge port (41, col. 4, lines 24-26: “second lumen 35 to irrigate the chest cavity or to otherwise introduce medication through at least one opening 41 in lumen 35”) is formed in the outer skin (outer surface of 11 in Fig. 6, see Fig. 1 where 41 extends through the wall of 11 to be in fluid communication with the surrounding tissue/space).
With respect to claim 7, James discloses a kit for inserting a chest tube and injecting a drug (see Figs. 6-11, col. 3, lines 62-63: “Catheter tube 11 includes a first lumen 17 which is formed by central bore 19 of tube 11”, central bore 19 is configured for conveying a chest tube, and the kit is further able to inject a drug via 43 and 41), comprising:
a chest tube inserter (11 in Fig. 6) having an insert guide hole (19, see col. 3 lines 62-63 as cited above) formed through an inside of a body part (body of 11) so that a chest tube is inserted (a chest tube is insertable through central bore 19), wherein the body part (body of 11) is formed in a double skin structure (tube 11 is layered with an internal wall and an external wall defining secondary lumen 35) so that a drug-receiving part (35) is provided on an inside thereof (35 is within the wall of tube 11); and
a cutter (27 in Figs. 5 and 6) having a blade formed at a front thereof and configured to incise a chest wall (col. 4, lines 12-14: “Stylette 27 also has a sharp pointed tip 23 to penetrate the outer regions of the patient as the device is placed percutaneously in patients”) in a state of being inserted into the insert guide hole (19) of the chest tube inserter (11, see Figs. 4 and 6, the sharp end of cutter 27 penetrates the chest wall when placed through the guide hole 19 of the chest tube inserter 11).
Claim Rejections - 35 USC § 103
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over James (US Patent No. 5,279,551), as applied to claim 1 above, and further in view of Marczyk et al. (US PGPub 2014/0371537 A1).
Regarding claim 4, James discloses wherein the inner skin (inner surface of 17 in Fig. 6) is formed of a ductile material (col. 3, lines 56-57: “The tube 11 is formed from clear, flexible medically inert material”), but fails to disclose wherein the outer skin is formed of a rigid material.
In the same field of surgical access assemblies (abstract), Marczyk et al. teaches an inserter (see 120 in Fig. 1, see also Fig. 2 for assembled view) comprising an outer skin (exterior of 120), wherein the outer skin is formed of a rigid material (see 122, PP [0041]: “The pair of first wings 122 is constructed from a rigid material”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the James device according to the teachings of Marczyk et al. to include the wings (122 and 124) as taught on the outer surface of the tube of James such that the outer skin is formed of a rigid material (by incorporating the wings of Marczyk et al. onto the device of James, the outer skin would include and incorporate the rigid material of wing 122). One of ordinary skill in the art would have been motivated to perform this modification in order to “provide support for the fingers of a surgeon to aid in the insertion of the [inserter]”, and furthermore to enable sutures to be received for the purposes of securing the device to the skin of a patient (see PP [0041] of Marczyk et al.). The modification as proposed would not alter the main operating principle of the James device, but would simply and predictably yield an improved combination configured for easier handling and for securement against the patient.
Regarding claim 5, James fails to disclose wherein a suture wing is formed at a rear end of the body part.
In the same field of surgical access assemblies (abstract), Marczyk et al. teaches an inserter (see 120 in Fig. 1, see also Fig. 2 for assembled view), wherein a suture wing (122 and 124) is formed at a rear end of a body part of the inserter (120, the wings are on a proximal side of the inserter, see Fig. 2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the James device according to the teachings of Marczyk et al. to include the wings as taught. One of ordinary skill in the art would have been motivated to perform this modification in order to “provide support for the fingers of a surgeon to aid in the insertion of the [inserter]”, and furthermore to enable sutures to be received for the purposes of securing the device to the skin of a patient (see PP [0041] of Marczyk et al.). The modification as proposed would not alter the main operating principle of the James device, but would simply and predictably yield an improved combination configured for easier handling and for securement against the patient.
Regarding claim 6, James as modified by Marczyk et al. further discloses wherein at least one fixing hole (210 in Fig. 2 of Marczyk et al., PP [0041]: “The second pair of wings 124 includes openings 210 (see FIG. 2) configured to receive sutures therethrough, thus suturing the sleeve 120 to the skin of a patient”) is formed in the suture wing (124).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over James (US Patent No. 5,279,551), as applied to claim 7 above, and further in view of Schaller et al. (US Patent No. 5,368,545).
Regarding claim 8, James fails to disclose a cover pad attached to a skin to cover the inserted chest tube inserter.
In the related field of laparoscopic operations (abstract), which is related due to its similar concern with the insertion of instruments through an incision, Schaller et al. teaches a cover pad (27 in Fig. 2) for attachment to a patient’s skin to cover a chest tube inserter (36 and 30 are radially covered as the cover pad 27 surrounds the inserted portions).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the James kit to incorporate the cover pad of the Schaller et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to protect the skin of the patient from any undesired contamination during the surgical procedure (col. 2, lines 38-54). The modification as proposed furthermore would not alter the main operating principle of the James kit, but would simply and predictably provide a barrier around the incision that would not affect the operations of the James kit.
Regarding claim 9, James as modified by Schaller et al. further discloses wherein a chest tube exposure hole (26 in Fig. 2) is formed in the cover pad (27) at a location where the chest tube passes through (see 36 entering along arrow 35 into ring 26).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shelton et al. (US PGPub 2019/0000441 A1) teaches a surgical access device (see Figs. 5-7) comprising wings (130) for receiving sutures (see suture passer 136 and thread 152 in Fig. 6) and a plurality of ports (124) configured to convey medication or surgical instruments such as chest tubes (PP [0084]: “Each surgical instrument channel (124) has an entrance end at proximal face (118) and an exit end at distal face (120), and is configured to guide a surgical instrument (not shown) distally through access device (100) and into a body cavity. Such surgical instruments may include various endoscopic instruments such as endoscopes, grasping instruments, and cutting instruments, for example. Proximal face (118) of insert (104) includes a plurality of instrument entry guide members (126), shown in the form of ring structures, configured to guide insertion of surgical instruments into the entrance ends of instrument channels (124)”).
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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