DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 26 July 2023. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 26 July 2023 are accepted by the examiner.
Specification
The amendment filed 26 July 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of International Patent Application No. PCT/US2022/014385 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 28 January 2022, see MPEP 1893.03(b). Therefore the specification amendment of 26 July 2023 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Note: This issue can be remedied by removing the statement "the entire content of which is incorporated by reference herein " from paragraph 0001 of the specification.
Claim Objections
Claim 1 is objected to because of the following informality:
In line 1, it appears that the phrase “procedures comprises” should read “procedures comprising.”
Claim 7 is objected to because of the following informalities:
In lines 2-3, it appears that the phrase “user’s skin” (i.e. three separate instances) should read “patient’s skin” for consistency (see line 2 of claim 6 for antecedent basis).
Claim 10 is objected to because of the following informalities:
In lines 2-3, it appears that the phrase “user’s body” (i.e. two separate instances) should read “patient’s body” for consistency (see line 2 of claim 6 for antecedent basis).
In line 3, it appears that the phrase “the point of interest” should read “a point of interest.”
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.
Claims 9-13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites the limitation "the inner cavity" in line 2. There is insufficient antecedent basis for this limitation in the claim. Since claims 10-13 are dependent upon claim 9, they contain the same issue.
Note: It appears that amending line 2 of claim 9 to read “an inner cavity” would overcome this rejection. For examination purposes, claim 9 will be treated as such.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christopher (U.S. Patent 6,585,642).
Regarding claims 1 and 2, Christopher discloses (as to claim 1) a system (see Figure 1) capable of being used to perform percutaneous procedures comprising a working channel (i.e. channel defined by 10 and 30), the working channel including an inner wall (i.e. wall defining 35 and contacting 40 as best seen in Figure 4); an outer wall (i.e. wall defining outer periphery of 30 as best seen in Figure 4) surrounding the inner wall; a side opening (35) formed between the inner wall and the outer wall along a length (see column 4, lines 22-24) of the working channel; a first end (i.e. end defining 22) having a first width (i.e. width defined by 22); a second end (i.e. end defining 36) having a second width (i.e. width defined by 36), wherein the second width is less than the first width (see Figure 1); and at least one tool (see column 4, lines 19-21) capable of being received in (i.e. received in 32) the working channel, wherein (as to claim 2) the system further comprises at least one fastener (38) connected to the working channel (see Figure 6), wherein the at least one fastener is capable of receiving a suction hose (40) connected to (i.e. via 44) a suction source (see column 5, lines 12-15) (see Figures 1-6, and column 3, line 65 – column 6, line 40).
Regarding claims 14 and 15, Christopher discloses (as to claim 14) a working channel (i.e. channel defined by 10 and 30) comprising an inner wall (i.e. wall defining 35 and contacting 40 as best seen in Figure 4); an outer wall (i.e. wall defining outer periphery of 30 as best seen in Figure 4) surrounding the inner wall; a side opening (35) formed between the inner wall and the outer wall along a length (see column 4, lines 22-24) of the working channel; a first end (i.e. end defining 22) having a first width (i.e. width defined by 22); and a second end (i.e. end defining 36) having a second width (i.e. width defined by 36), wherein the second width is less than the first width (see Figure 1), wherein (as to claim 15) the working channel further comprises at least one fastener (38) connected to the working channel (see Figure 6), wherein the at least one fastener is capable of receiving a suction hose (40) connected to (i.e. via 44) a suction source (see column 5, lines 12-15) (see Figures 1-6, and column 3, line 65 – column 6, line 40).
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.
Claims 1 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kornel (U.S. Patent 8,486,077) in view of Strauss et al. (U.S. Patent 8,696,560).
Regarding claims 1 and 6-13, Kornel discloses (as to part of claim 1) a system (see Figure 4) capable of being used to perform percutaneous procedures (see Abstract) comprising a working channel (42), the working channel including an inner wall (i.e. wall defining interior of U shape as best seen in Figure 4); an outer wall (i.e. wall defining exterior of U shape as best seen in Figure 4) surrounding the inner wall; a side opening (i.e. lower opening defining opening of U shape as best seen in Figure 4) formed between the inner wall and the outer wall along a length (see Figure 4) of the working channel; a first end (i.e. left-most end of 42 as best seen in Figure 4) having a first width (i.e. width defined by left-most end of 42); a second end (i.e. right-most end of 42 as best seen in Figure 4) having a second width (i.e. width defined by right-most end of 42); and at least one tool (e.g. 43) capable of being received in the working channel (see column 3, lines 24-30), wherein (as to claim 6) the at least one tool comprises a trocar (41) capable of making an incision in a patient's skin and extending into the patient's body, wherein (as to claim 7) the working channel is capable of entering the patient's skin with the first end positioned under the patient 's skin and the second end extending outside of the patient's skin (see Note below regarding functional language), wherein (as to claim 8) the trocar is capable of being received in the working channel and withdrawn therefrom after the trocar reaches a desired position in the patient's body (see Note below regarding functional language), wherein (as to claim 9) the system further comprising a second tool (e.g. a(n) dilator/endoscope/syringe/decorticator, see column 3, lines 24-30) capable of being received in an inner cavity (i.e. cavity defined by side opening and inner wall) of the working channel, wherein (as to claim 10) the second tool comprises a dilator (16) capable of expanding a path made by the trocar through the patient 's body and capable of being removed from the working channel after extending to the point of interest in the patient's body, wherein (as to claim 11) the second tool comprises an endoscope (see column 3, lines 24-30), wherein (as to claim 12) the second tool comprises a syringe (see column 3, lines 24-30), and wherein (as to claim 13) the second tool comprises a decorticator (see column 3, lines 24-30) (see Figures 1-4, and column 3, line 4 – column 4, line 51).
Kornel discloses the claimed invention except for wherein (as to the remainder of claim 1) the second width is less than the first width.
Strauss et al. teach the use of a working channel (100) including an inner wall (i.e. wall defining interior of 100 as best seen in Figure 1B); an outer wall (i.e. wall defining exterior of 100 as best seen in Figure 1B) surrounding the inner wall; at least one side opening (i.e. openings defined between 110 and 120 as best seen in Figure 1B) formed between the inner wall and the outer wall along a length (see Figure 1B) of the working channel; a first end (i.e. top-most end of 100 as best seen in Figure 1B) having a first width (i.e. width defined by top-most end of 100); a second end (i.e. bottom-most end of 100 as best seen in Figure 1B) having a second width (i.e. width defined by bottom-most end of 100), wherein the second width is less than the first width (i.e. due to funnel shape, see Figure 1B) (see Figures 1A-1C, and column 4, line 54 – column 6, line 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Kornel with wherein the second width is less than the first width in view of Strauss et al. in order to provide a well-known, obvious channel shape allowing for increased access space, visibility, and the ability to insert and remove additional tools at the first end without interfering with a surgeon’s ability to perform the surgery to yield predictable results.
Regarding claim 14, Kornel discloses (as to part of claim 14) a working channel (42) comprising an inner wall (i.e. wall defining interior of U shape as best seen in Figure 4); an outer wall (i.e. wall defining exterior of U shape as best seen in Figure 4) surrounding the inner wall; a side opening (i.e. lower opening defining opening of U shape as best seen in Figure 4) formed between the inner wall and the outer wall along a length (see Figure 4) of the working channel; a first end (i.e. left-most end of 42 as best seen in Figure 4) having a first width (i.e. width defined by left-most end of 42); and a second end (i.e. right-most end of 42 as best seen in Figure 4) having a second width (i.e. width defined by right-most end of 42) (see Figures 1-4, and column 3, line 4 – column 4, line 51).
Kornel discloses the claimed invention except for wherein (as to the remainder of claim 14) the second width is less than the first width.
Strauss et al. teach the use of a working channel (100) including an inner wall (i.e. wall defining interior of 100 as best seen in Figure 1B); an outer wall (i.e. wall defining exterior of 100 as best seen in Figure 1B) surrounding the inner wall; at least one side opening (i.e. openings defined between 110 and 120 as best seen in Figure 1B) formed between the inner wall and the outer wall along a length (see Figure 1B) of the working channel; a first end (i.e. top-most end of 100 as best seen in Figure 1B) having a first width (i.e. width defined by top-most end of 100); a second end (i.e. bottom-most end of 100 as best seen in Figure 1B) having a second width (i.e. width defined by bottom-most end of 100), wherein the second width is less than the first width (i.e. due to funnel shape, see Figure 1B) (see Figures 1A-1C, and column 4, line 54 – column 6, line 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Kornel with wherein the second width is less than the first width in view of Strauss et al. in order to provide a well-known, obvious channel shape allowing for increased access space, visibility, and the ability to insert and remove additional tools at the first end without interfering with a surgeon’s ability to perform the surgery to yield predictable results.
Note: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Claims 3-5 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kornel (U.S. Patent 8,486,077) in view of Strauss et al. (U.S. Patent 8,696,560), as applied to claim 1 above, further in view of Kogasaka et al. (U.S. Patent 6,371,968).
Regarding claims 3-5, Kornel in view of Strauss et al. disclose the claimed invention except for wherein (as to claim 3) the system further comprises an integral suction element formed in at least one of the inner wall and the outer wall of the working channel, wherein (as to claim 4) the inner wall includes at least one suction opening formed therein and in fluid communication with the integral suction element, and wherein (as to claim 5) the system further comprising a suction connector provided in at least one of the inner wall and the outer wall and capable of providing a connection between the integral suction element and a suction supply.
Kogasaka et al. teach the use of a working channel (1) including an inner wall (i.e. wall defining interior of 1 as best seen in Figure 21); an outer wall (i.e. wall defining exterior of 1 as best seen in Figure 21) surrounding the inner wall; an integral suction element (111a) formed in at least one of the inner wall and the outer wall of the working channel, wherein the inner wall includes at least one suction opening (i.e. opening defined at interior of 1 as bests seen in Figure 22) formed therein and in fluid communication with the integral suction element; and a suction connector (112) provided in at least one of the inner wall and the outer wall and capable of providing a connection between the integral suction element and a suction supply (see Figure 22, and column 21, line 59 – column 22, line 58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Kornel in view of Strauss et al. with wherein the system further comprises an integral suction element formed in at least one of the inner wall and the outer wall of the working channel, wherein the inner wall includes at least one suction opening formed therein and in fluid communication with the integral suction element, and wherein the system further comprising a suction connector provided in at least one of the inner wall and the outer wall and capable of providing a connection between the integral suction element and a suction supply in view of Kogasaka et al. in order to provide a well-known, obvious means for providing an air vent, water-suction, and/or a water supply without interfering with the inner cavity of the working channel to yield predictable results.
Regarding claims 16-17 and 19, Kornel in view of Strauss et al. disclose the claimed invention except for wherein (as to claim 16) the working channel further comprises an integral suction element formed in at least one of the inner wall and the outer wall, wherein (as to claim 17) the working channel further comprises at least one suction opening formed in the inner wall and in fluid communication with the integral suction element, and wherein (as to claim 19) the system further comprising at least one suction connector capable of providing a fluid connection between the integral suction element and a suction supply.
Kogasaka et al. teach the use of a working channel (1) including an inner wall (i.e. wall defining interior of 1 as best seen in Figure 21); an outer wall (i.e. wall defining exterior of 1 as best seen in Figure 21) surrounding the inner wall; an integral suction element (111a) formed in at least one of the inner wall and the outer wall of the working channel, wherein the inner wall includes at least one suction opening (i.e. opening defined at interior of 1 as bests seen in Figure 22) formed therein and in fluid communication with the integral suction element; and a suction connector (112) provided in at least one of the inner wall and the outer wall and capable of providing a fluid connection between the integral suction element and a suction supply (see Figure 22, and column 21, line 59 – column 22, line 58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Kornel in view of Strauss et al. with wherein the working channel further comprises an integral suction element formed in at least one of the inner wall and the outer wall, wherein the working channel further comprises at least one suction opening formed in the inner wall and in fluid communication with the integral suction element, and wherein the system further comprising at least one suction connector capable of providing a fluid connection between the integral suction element and a suction supply in view of Kogasaka et al. in order to provide a well-known, obvious means for providing an air vent, water-suction, and/or a water supply without interfering with the inner cavity of the working channel to yield predictable results.
Regarding claims 18 and 20, Kornel in view of Strauss et al. further in view of Kogasaka et al. disclose the claimed invention except for wherein (as to claim 18) the working channel further comprises a plurality of suction openings formed in the inner wall and in fluid communication with the integral suction element, and wherein (as to claim 20) the working channel further comprises a second integral suction element formed in a least one of the inner wall and the outer wall.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Kornel in view of Strauss et al. further in view of Kogasaka et al. with wherein the working channel further comprises a plurality of suction openings formed in the inner wall and in fluid communication with the integral suction element, and wherein the working channel further comprises a second integral suction element formed in a least one of the inner wall and the outer wall in order to provide multiple well-known and obvious means for providing air vents, water-suction, and/or water supplies without interfering with the inner cavity of the working channel to yield predictable results. Furthermore, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Richards et al. (U.S. Patent Application Publication 2005/0277811) disclose a system comprising a working channel including an inner wall, an outer wall, and a side opening.
Mather et al. (U.S. Patent 10,524,831) disclose a system comprising a working channel including an inner wall, an outer wall, and a side opening.
Lee et al. (U.S. Patent 5,645,519) disclose a system comprising a working channel including an inner wall, an outer wall, and a side opening.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775