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
Applicant's arguments filed 1/6/26 regarding claims 1, 9 and 10 have been fully considered but they are not persuasive.
Applicant argues the needles or blades of Debbas fail to extend beyond an outer perimeter of the trocar/casing tube while the housing tube remains positioned within the trocar.
However, Examiner notes the limitations “while the housing tube remains positioned within the trocar/casing tube such that the at least one cutting blade extends radially outward beyond an outer perimeter of the trocar/casing tube” are relative to a trocar/casing tube which is not positively recited in the claim. Therefore, the prior art is not required to explicitly show a casing tube or the deployment assembly deploying while positioned within the trocar/casing tube, but only blades or needles that extend radially outward and sized to be received within a trocar/casing tube to read on the claim limitations.
Applicant’s arguments with respect to claim(s) 1-11 have been considered but are moot because the new ground of rejection over Clark, III et al U S 2010/0228182 as discussed below.
New claims 13-17 have been newly added.
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.
Claim 10 is 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 10 recites the limitation "trocar" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the positioning structure” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the proximal portion of the trocar” on line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the stop mechanism” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 9 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Debbas US 2003/0171764.
Regarding claim 1, Debbas discloses a surgical instrument for insertion through a laparoscopic trocar/casing tube (closing an opening in which a trocar is used, paragraph 0002), the instrument comprising: a housing tube 2 sized for passage through a trocar/casing tube (may be sized to fit through any trocar/casing tube that is a larger size); a deployment assembly 3 at least partially disposed within the housing tube (paragraph 0029, received in tube 2, figure 7b); and at least one cutting blade coupled to the deployment assembly (needles 30, 31, figure 1a, 7a), the at least one cutting blade having a sharpened cutting edge (paragraphs 0012, needles 30, 31 pierce through tissue), and the at least one cutting blade movable between a retracted position within a perimeter diameter defined by the housing tube (for example, figures 1a, 5a, 7b) and an extended position projecting beyond the perimeter diameter (figures 3, 5b), wherein the deployment assembly is configured to deploy the at least one cutting blade while the housing tube remains positioned within the trocar/casing tube such that the at least one cutting blade extends radially outward beyond an outer perimeter of the trocar/casing tube (blades extend outward as shown in figure 5B), and wherein the at least one cutting blade is configured to cut tissue during simultaneous withdrawal of both the instrument and the trocar/casing tube from a body cavity (figure 5C, paragraph 0017; Examiner notes the trocar/casing tube is not positively claimed, and the deployment assembly may be configured to be inserted through a trocar/casing tube when inserted through tissue, the deployment assembly is retracted or withdrawn to cut through tissue, and may be configured to be withdrawn with the trocar/casing tube if positioned within the trocar/casing tube).
Regarding claim 9, Debbas discloses wherein the at least one cutting blade extends and retracts by pivoting, and wherein the at least one cutting blade pivots through a range of motion from a position substantially aligned with a longitudinal axis of the housing tube in the retracted position to a position extending radially outward at an angle to the longitudinal axis in the extended position (pivot the needles outward through slots 7, 8 in the tube, for example, figure 5a substantially aligned with the longitudinal axis, figure 5b extended outward at an angle).
Regarding claim 10, Debbas discloses wherein the tube has a proximal end 2a (figure 1b) and a distal end 2b (figure 1b), wherein the at least one cutting blade is at the distal end (needles 30, 31 attached at the distal end of threaded portion 12, figure 3), and wherein the sharpened cutting edge faces the proximal end when the at least one cutting blade is in the extended position (needle tip faces proximally up through tissue when extended, figure 5b), and wherein the sharpened cutting edge is oriented to cut tissue as the instrument and trocar are simultaneously withdrawn proximally from the body cavity (configured and sized to be within drawn with a trocar, Examiner notes the trocar/casing tube is not claimed).
Claim(s) 1, 13, 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark, III et al. US 2010/0228182.
Regarding claims 1 and 13, Clark, III et al. discloses a surgical instrument for enlarging a tissue opening or for insertion through or comprising a laparoscopic trocar/casing tube 2101 (for example, figure 21A), the instrument comprising: a housing tube 1801 sized for passage through a trocar/casing tube (deployment assembly may include outer housing 2101, paragraph 0154) and through a tissue opening (blades 1902 cut tissue); a deployment assembly (2002, 2004; figure 20) at least partially disposed within the housing tube (figure 20); and at least one cutting blade coupled to the deployment assembly (blades 1902, figure 20), the at least one cutting blade having a sharpened cutting edge (blades for cutting fibrous tissue, paragraphs 0136, 0137, 0144), and the at least one cutting blade movable between a retracted position within a perimeter diameter defined by the housing tube and an extended position projecting beyond the perimeter diameter (figure 20 shown in extended position, being positioned by moving deployment member 2002 to release from constrained position by pivoting, paragraph 0136, 0138), wherein the deployment assembly is configured to deploy the at least one cutting blade while the housing tube remains positioned within the trocar/casing tube such that the at least one cutting blade extends radially outward beyond an outer perimeter of the trocar/casing tube or tissue opening, and wherein the at least one cutting blade is configured to cut tissue or enlarge the opening during simultaneous withdrawal of both the instrument and the trocar/casing tube from a body cavity (Examiner notes the trocar/casing tube is not positively claimed, and the deployment assembly may be configured to be inserted through a trocar/casing tube, such as tube 2101, when inserted through tissue, the deployment assembly is retracted or withdrawn to cut through tissue, and may be configured to be withdrawn with the trocar/casing tube if at least partially positioned within the trocar/casing tube).
Regarding claim 14, Clark, III et al. discloses wherein the tissue opening is selected from the group consisting of: a natural body orifice, a surgical incision in skin, an opening in fascia, an opening in a vessel wall and an opening in an organ wall (configured to cut skin or a body orifice or vessel wall or connective tissue, paragraph 0131).
Regarding claim 15, Clark, III et al. discloses the instrument is configured for direct insertion through the tissue opening without requiring insertion through a separate trocar or casing tube (may include an outer or separate casing tube such as 2101, but not required to be inserted through a incision).
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.
Claim(s) 2 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark, III et al. US 2010/0228182 in view of Jinno US 2020/0253677.
Regarding claims 2 and 16, Clark, III et al. discloses an instrument comprising the deployment assembly (figure 20), the deployment assembly comprising a motor (paragraph 0142, support mechanisms are not intended to be exhaustive, the blades may use a switchblade like mechanism or electric motor to move the blades from a collapsed and extended position), but fails to disclose: a first pulley mechanically connected to the motor; a second pulley proximate a second end of the tube; a flexible belt extending longitudinally through the housing tube from the first pulley to the second pulley, the flexible belt having a length substantially equal to a length of the housing tube; and the at least one cutting blade coupled to the second pulley, wherein rotation of the first pulley causes movement of the flexible belt to rotate the second pulley, and wherein movement of the second pulley causes extension and retraction of the at least one cutting blade.
Jinno teaches an instrument for moving an end mechanism 10, a deployment assembly at least partially within a housing tube 20 (Figure 9), and end effector assembly 10 having an open and closed configuration (figure 3, blades or gripper members open), the deployment assembly comprising a, a first pulley mechanically 312 connected to the motor 311 (figure 9); a second pulley proximate a second end of the tube (pulley 316, figure 10, paragraph 0073); a flexible belt extending longitudinally through the housing tube from the first pulley to the second pulley (161 or 162, figure 10) , the flexible belt having a length substantially equal to a length of the housing tube (paragraph 0073, extends from motor in housing 304 through shaft 20 to end effector); and the at least one end effector coupled to the second pulley (paragraph 0073) , wherein rotation of the first pulley causes movement of the flexible belt to rotate the second pulley, and wherein movement of the second pulley causes extension and retraction of the at least one end effector jaw (paragraph 0045, 0073, belt or wire rotates around pulley and rotates the end effector gripper members in end portion 10), a housing 304 for the motor 311 may provide a positioning structure configured to engage the proximal end of the trocar as the stop mechanism (figure 9, housing extends laterally from shaft 20 and may be configured as a depth stop).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Clark, III et al. with a motor and first and second pulley system causing extension or retraction of the end effector of cutting blade, as taught by Jinno as known in the art to substitute a deployment assembly for moving blades or jaws by transmitting force along a belt or wire between a first and second pulley extending along a longitudinal axis of the housing tube.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark, III et al. US 2010/0228182 in view of Lichtman US 5308357.
Regarding claim 3, Clark, III et al. discloses an instrument comprising the deployment assembly (figure 20), but fails to disclose wherein the deployment assembly comprises: manually operable handles located at a proximal end of the instrument, the manually operable handles comprising first and second handles pivotally connected to a central rod; and a mechanical linkage connecting the handles to the at least one cutting blade, wherein the mechanical linkage comprises a spring mechanism that is exposed when the handles move together; and wherein movement of the manually operable handles causes extension and retraction of the at least one cutting blade, and wherein depressing a knob actuates the spring mechanism that causes the extension of the at least one cutting blade.
Lichtman teaches a handle mechanism for actuating instrument blades or jaws 14A, 14B (figure 17), wherein the deployment assembly comprises: manually operable handles(32A, 32B, or 132A, 132B figures 10, 11) located at a proximal end of the instrument (for example, figures 10, 11), the manually operable handles comprising first and second handles pivotally connected to a central rod (connected to rod 42 or operating rod 4); and a mechanical linkage connecting the handles to the at least one blades 14A, 14B (figures 10, 17, jaws 14A, 14B connected to handles through device and pivot block 20 or 120, for example, Examiner notes any connection or set of connections may be considered), wherein the mechanical linkage comprises a spring mechanism (76 or 76A, figures 10, 11) that is exposed when the handles move together (spring is always exposed, figures 10, 11); and wherein movement of the manually operable handles causes extension and retraction of the at least one blades (moving handles moves end effector jaws 14A, 14B), and wherein depressing a knob actuates the spring mechanism that causes the extension of the at least one cutting blade (knob 70 is affixed to spring 76 and handles and operating rod 4, when depressed the tissue may be released or blades expanded into the open position, column 9, lines 26-54).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Clark, III et al. with a deployment assembly comprising: manually operable handles located at a proximal end of the instrument, the manually operable handles comprising first and second handles pivotally connected to a central rod; and a mechanical linkage connecting the handles to the at least one cutting blade, wherein the mechanical linkage comprises a spring mechanism that is exposed when the handles move together; and wherein movement of the manually operable handles causes extension and retraction of the at least one cutting blade, and wherein depressing a knob actuates the spring mechanism that causes the extension of the at least one blade or end effector, as taught by Lichtman, to provide a deployment assembly comprising a handle assembly for moving blades or an end effector from an open to closed position for the desired procedure.
Claim(s) 6-8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clark, III et al. US 2010/0228182 in view of Zhu et al. US 5407427.
Regarding claims 6-8 and 11, Clark, III et al. discloses a surgical instrument comprising: a laparoscopic trocar/casing tube 2101 (for example, figure 21A), the instrument comprising: a housing tube 1801 sized having a diameter less than the trocar/casing tube (deployment assembly may include outer housing 2101, paragraph 0154); a deployment assembly (2002, 2004; figure 20) at least partially disposed within the housing tube (figure 20); the deployment assembly selected from the group consisting of a motor driven belt system, a manual system, and a rod retractor system (rod 2002 retracted, figure 20, may be a manual switchblade system or motorized, paragraph 0142), and at least one cutting blade coupled to the deployment assembly (blades 1902, figure 20), the at least one cutting blade having a sharpened cutting edge (blades for cutting fibrous tissue, paragraphs 0136, 0137, 0144), and the at least one cutting blade movable between a retracted position within a perimeter diameter defined by the housing tube and an extended position projecting beyond the perimeter diameter (figure 20 shown in extended position, being positioned by moving deployment member 2002 to release from constrained position by pivoting, paragraph 0136, 0138), wherein the deployment assembly is configured to deploy the at least one cutting blade while the housing tube remains positioned within the trocar/casing tube such that the at least one cutting blade extends radially outward beyond an outer perimeter of the trocar/casing tube, and wherein the at least one cutting blade is configured to cut through skin, fascia, and peritoneum during simultaneous withdrawal of both the instrument and the trocar/casing tube from a body cavity (Examiner the deployment assembly may be configured to be inserted through a trocar/casing tube, such as tube 2101, when inserted through tissue, the deployment assembly is retracted or withdrawn to cut through tissue, such as the skin, fascia or peritoneum, and may be configured to be withdrawn with the trocar/casing tube if at least partially positioned within the trocar/casing tube).
Clark, III et al. fails to further comprise a positioning structure disposed on the housing tube and configured to engage a proximal portion of the trocar, wherein the positioning structure serves as a stop mechanism indicating proper depth of insertion of the instrument within the trocar, a positioning element disposed on an exterior surface of the housing tube to separate the housing tube from an interior wall of the trocar, wherein the positioning element has a thickness selected based on an inner diameter of the trocar to provide a snug fit of the housing tube within the trocar, wherein the housing tube has an exterior diameter between 5 millimeters and 15 millimeters, and wherein the housing tube is configured to fit within a trocar having a corresponding inner diameter between 5 millimeters and 15 millimeters, or a positioning element maintaining alignment of the housing tube within the trocar/casing tube. Clark, III et al. discloses the shaft 2101 has an inner diameter sufficient to enclose cutting tool (paragraph 0155), but fails to explicitly disclose but fails to explicitly disclose wherein the housing tube has an exterior diameter between 5 millimeters and 15 millimeters, and wherein the housing tube is configured to fit within a trocar having a corresponding inner diameter between 5 millimeters and 15 millimeters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Clark, III et al. to have wherein the housing tube has an exterior diameter between 5 millimeters and 15 millimeters, and wherein the housing tube is configured to fit within a trocar having a corresponding inner diameter between 5 millimeters and 15 millimeters. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
Zhu et al. discloses a trocar facilitator comprising a shaft having a bump 68 depth engage with outer tube ledge 66 of outer cannula (figures 2 and 3) discloses a trocar assembly a positioning structure 68 disposed on the housing tube (inner tube 40) and configured to engage a proximal portion of the trocar (engages ledge 66 of outer tube, figure 4), wherein the positioning structure serves as a stop mechanism indicating proper depth of insertion of the instrument within the trocar (stop mechanism for the device, column 8, lines 20-28) , a positioning element disposed on an exterior surface of the housing tube to separate the housing tube from an interior wall of the trocar (figure 2), wherein the positioning element has a thickness selected based on an inner diameter of the trocar to provide a snug fit of the housing tube within the trocar (bump 68 engages with outer tubular member at ledge 68 with stop 64), or a positioning element maintaining alignment of the housing tube within the trocar/casing tube (bump 68 engages with ledge 66 of stop mechanism 64, figure 2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Clark, III et al., with a positioning structure disposed on the housing tube and configured to engage a proximal portion of the trocar, wherein the positioning structure serves as a stop mechanism indicating proper depth of insertion of the instrument within the trocar, a positioning element disposed on an exterior surface of the housing tube to separate the housing tube from an interior wall of the trocar, wherein the positioning element has a thickness selected based on an inner diameter of the trocar to provide a snug fit of the housing tube within the trocar, as taught by Zhu et al. to provide a bump on an inner shaft and a ledge on an outer shaft to allow for a depth gauge and to maintain alignment.
Allowable Subject Matter
Claims 4, 5 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record and at large fails to disclose wherein the deployment assembly comprises: a rod disposed longitudinally within the housing tube, the rod having a threaded portion at a distal end; a threaded ring at a distal portion of the housing tube, the threaded ring engaged with the threaded portion of the rod, wherein rotation of the rod causes longitudinal movement of the rod through the threaded ring; a link secured to the distal end of the rod and movable longitudinally with the rod; a first set of cutting blade-links, each cutting blade-link of the first set having a proximal end connected to the threaded ring at a first connection point and a distal end, wherein the cutting blade-links of the first set comprise cutting edges along radially outer portions; a second set of cutting blade-links, each cutting blade-link of the second set having a proximal end joined to the link at a second connection point and an intermediate portion joined to the distal end of a respective cutting blade-link of the first set at a third connection point, wherein the cutting blade-links of the second set comprise cutting edges along radially outer portions; wherein the first, second, and third connection points comprise pins allowing rotational movement; wherein rotation of the rod causes the link to move longitudinally, thereby causing the first set of cutting blade-links to pivot radially outward about the first connection point while the second set of cutting blade-links simultaneously pivot radially outward about the second connection point.
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.
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/C.C.L/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771