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 . 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.
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 18 and 38 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 18 recites the limitation "the controller" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the surgical device" in line 1. 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) 16, 17, 20-25, 27-31, and 33-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McClurken, U.S. 7,537,595 (hereinafter McClurken).
Regarding claim 16, McClurken discloses (note figs. 1, 7, 8, and 44-47) a system, comprising: a surgical device comprising a handle (note fig. 7), a shaft (19) extending from the handle, and a thermal assembly (note figs. 44-45) coupled to the shaft, the thermal assembly including a heating element (29a/30a) and an electrically insulative and thermally insulative substrate (‘26’ – note abstract and col. 21, line 49), the heating element including an electrically resistive material disposed on the substrate (note col. 10, line 30), wherein the thermal assembly comprises a blunted paraboloid having a distal tip end and a generally circular proximal end (note figs. 44-46); a source of energy (6) coupled to the heating element, the source of energy configured to apply an electrical current to the heating element; and a temperature detection mechanism (note col. 16, line 39; col. 26, line 42) configured to detect a temperature of the heating element, wherein the thermal assembly is operably coupled to a distal end of the shaft (see fig. 46), and the heating element comprises a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite sides of the substrate, each of the tabs coupleable to electrical conductors (21a-b) within the shaft such that electrical current is passed through the heating element ‘between’ the set of tabs (due to their opposing polarity – note col. 24, line 34) to necessarily heat (at least slightly) the thermal assembly (note col. 10, line 48).
Regarding claim 17, McClurken discloses (see above) a system wherein the handle comprises a switch electrically coupled to the source of energy, the switch configured to activate the source of energy to apply electrical current to the heating element (note col. 9, line 31).
Regarding claim 20, McClurken discloses (see above) a system wherein the system is capable of heating the thermal assembly to a temperature in the range of about 80 degrees Celsius to 110 degrees Celsius within one second of activation, wherein the system is capable of cooling the thermal assembly to a lower temperature within one second of deactivation.
Regarding claim 21, McClurken discloses (see above) a system wherein the heating element comprises a ‘double helical trace’ (see ‘29a’ and ‘30a’).
Regarding claim 22, McClurken discloses (see above) a system wherein the double helical trace necessarily covers the substrate ‘at’ the ‘distal tip end’ (note fig. 46).
Regarding claim 23, McClurken discloses (see above) a system wherein the substrate comprises an outlet port (44a) in fluidic communication with a fluid source, the outlet port capable of dispersing fluid from the thermal assembly such that the thermal assembly provides hemostatic sealing of bone or tissue using fluid application.
Regarding claim 24, McClurken discloses (note figs. 1, 7, 8, and 44-47) a surgical device, comprising: a handle (note fig. 7); a shaft (19) extending from the handle; and a thermal assembly (note figs. 44-45) coupled to the shaft, the thermal assembly including a heating element (29a/30a) and an electrically insulative and thermally insulative substrate (‘26’ – note abstract and col. 21, line 49), the heating element including an electrically resistive material disposed on the substrate (note col. 10, line 30), wherein the thermal assembly comprises a blunted paraboloid having a distal tip end and a generally circular proximal end (note figs. 44-46), wherein the thermal assembly is operably coupled to a distal end of the shaft (see fig. 46), and the heating element comprises a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite sides of the substrate, each of the tabs coupleable to electrical conductors (21a-b) within the shaft such that electrical current is passed through the heating element ‘between’ the set of tabs (due to their opposing polarity – note col. 24, line 34) to necessarily heat (at least slightly) the thermal assembly (note col. 10, line 48).
Regarding claim 25, McClurken discloses (see above) a surgical device wherein the handle comprises a switch electrically coupled to a source of energy, the switch configured to activate the source of energy to apply electrical current to the heating element (note col. 9, line 31).
Regarding claim 27, McClurken discloses (see above) a surgical device wherein the heating element comprises a ‘double helical trace’ (see ‘29a’ and ‘30a’).
Regarding claim 28, McClurken discloses (see above) a surgical device wherein the double helical trace necessarily covers the substrate ‘at’ the ‘distal tip end’ (note fig. 46).
Regarding claim 29, McClurken discloses (see above) a surgical device wherein the substrate comprises an outlet port (44a) in fluidic communication with a fluid source, the outlet port capable of dispersing fluid from the thermal assembly such that the thermal assembly provides hemostatic sealing of bone or tissue using fluid application.
Regarding claim 30, McClurken discloses (note figs. 1, 7, 8, and 44-47) a hemostatic sealer, comprising: a ‘handpiece’ having a source of energy (6), a handle (note fig. 7), and a thermal assembly (note figs. 44-45) including a heating element (29a/30a) and an electrically insulative and thermally insulative substrate (‘26’ – note abstract and col. 21, line 49), the heating element including an electrically resistive material disposed on the substrate (note col. 10, line 30), wherein the thermal assembly comprises a blunted paraboloid having a distal tip end and a generally circular proximal end (note figs. 44-46); and a shaft (19) extending from the handle, wherein the thermal assembly is operably coupled to a distal end of the shaft (see fig. 46), and the heating element comprises a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite sides of the substrate, each of the tabs coupleable to electrical conductors (21a-b) within the shaft such that electrical current is passed through the heating element ‘between’ the set of tabs (due to their opposing polarity – note col. 24, line 34) to necessarily heat (at least slightly) the thermal assembly (note col. 10, line 48).
Regarding claim 31, McClurken discloses (see above) a hemostatic sealer wherein the handle comprises a switch electrically coupled to the source of energy, the switch configured to activate the source of energy to apply electrical current to the heating element (note col. 9, line 31).
Regarding claim 33, McClurken discloses (see above) a hemostatic sealer wherein the heating element comprises a ‘double helical trace’ (see ‘29a’ and ‘30a’).
Regarding claim 34, McClurken discloses (see above) a hemostatic sealer wherein the double helical trace necessarily covers the substrate ‘at’ the ‘distal tip end’ (note fig. 46).
Regarding claim 35, McClurken discloses (see above) a hemostatic sealer wherein the substrate comprises an outlet port (44a) in fluidic communication with a fluid source, the outlet port capable of dispersing fluid from the thermal assembly such that the thermal assembly provides hemostatic sealing of bone or tissue using fluid application.
Claim(s) 16, 18, 20, 24, 30, and 36-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watkins, U.S. 6,393,314 (hereinafter Watkins).
Regarding claim 16, Watkins discloses (note figs. 1 and 3) a system, comprising: a surgical device comprising a handle (necessarily), a shaft (200) extending from the handle, and a thermal assembly (205) coupled to the shaft, the thermal assembly including a heating element (207) and an electrically insulative and thermally insulative substrate (note col. 3, line 66), the heating element including an electrically resistive material (note col. 3, line 66) disposed on the substrate, wherein the thermal assembly comprises a blunted paraboloid having a distal tip end and a generally circular proximal end (note fig. 3); a source of energy (157) coupled to the heating element, the source of energy configured to apply an electrical current to the heating element; and a temperature detection mechanism (note col. 4, line 53) configured to detect a temperature of the heating element, wherein the thermal assembly is operably coupled to a distal end of the shaft (see fig. 3), and the heating element comprises a set of ‘tabs’ (‘208’ – note col. 4, line 16) positioned on ‘opposite sides’ of the substrate (see fig. 2), each of the tabs coupleable to electrical conductors (‘210’ and ‘220’) within the shaft such that electrical current is passed through the heating element between the set of tabs to heat the thermal assembly (note col. 3, line 66 – col. 4, line 25).
Regarding claim 18, Watkins discloses (see above) a system wherein the source of energy is configured to receive a signal to apply electrical current to the heating element, wherein the temperature detection mechanism is configured to provide the detected temperature of the heating element to a controller (‘158’ - note col. 4, line 53), the controller configured to adjust the temperature of the heating element by controlling the source of energy (note col. 4, line 53).
Regarding claim 20, Watkins discloses (see above) a system wherein the system is capable of heating the thermal assembly to a temperature in the range of about 80 degrees Celsius to 110 degrees Celsius within one second of activation, wherein the system is capable of cooling the thermal assembly to a lower temperature within one second of deactivation.
Regarding claim 24, Watkins discloses (note figs. 1 and 3) a surgical device, comprising: a handle (necessarily); a shaft (200) extending from the handle; and a thermal assembly (205) coupled to the shaft, the thermal assembly including a heating element (207) and an electrically insulative and thermally insulative substrate (note col. 3, line 66), the heating element including an electrically resistive material (note col. 3, line 66) disposed on the substrate, wherein the thermal assembly comprises a blunted paraboloid having a distal tip end and a generally circular proximal end (note fig. 3), wherein the thermal assembly is operably coupled to a distal end of the shaft (see fig. 3), and the heating element comprises a set of ‘tabs’ (‘208’ – note col. 4, line 16) positioned on ‘opposite sides’ of the substrate (see fig. 2), each of the tabs coupleable to electrical conductors (‘210’ and ‘220’) within the shaft such that electrical current is passed through the heating element between the set of tabs to heat the thermal assembly (note col. 3, line 66 – col. 4, line 25).
Regarding claim 30, Watkins discloses (note figs. 1 and 3) a hemostatic sealer, comprising: a ‘handpiece’ having a source of energy (157), a handle (necessarily), and a thermal assembly (205) including a heating element (207) and an electrically insulative and thermally insulative substrate (note col. 3, line 66), the heating element including an electrically resistive material (note col. 3, line 66) disposed on the substrate, wherein the thermal assembly comprises a blunted paraboloid having a distal tip end and a generally circular proximal end (note fig. 3); and a shaft (200) extending from the handle, wherein the thermal assembly is operably coupled to a distal end of the shaft (see fig. 3), and the heating element comprises a set of ‘tabs’ (‘208’ – note col. 4, line 16) positioned on ‘opposite sides’ of the substrate (see fig. 2), each of the tabs coupleable to electrical conductors (‘210’ and ‘220’) within the shaft such that electrical current is passed through the heating element between the set of tabs to heat the thermal assembly (note col. 3, line 66 – col. 4, line 25).
Regarding claim 36, Watkins discloses (see above) a system wherein the surgical device does not include a fluid outlet port such that the thermal assembly is capable of providing hemostatic sealing of bone or tissue without application of fluid.
Regarding claim 37, Watkins discloses (see above) a surgical device wherein the surgical device does not include a fluid outlet port such that the thermal assembly is capable of providing hemostatic sealing of bone or tissue without application of fluid.
Regarding claim 38, Watkins discloses (see above) a hemostatic sealer wherein the surgical device (as best understood) does not include a fluid outlet port such that the thermal assembly is capable of providing hemostatic sealing of bone or tissue without application of fluid.
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClurken in view of Watkins.
Regarding claim 18, McClurken discloses (see above) a system comprising a temperature detection mechanism configured to detect a temperature of a heating element, and further comprising a controller necessarily configured to adjust the temperature of the heating element by controlling a source of energy (note col. 9, line 31), wherein the source of energy is necessarily configured to receive a signal to apply electrical current to the heating element (note col. 9, line 31). However, McClurken fails to explicitly disclose a system wherein the temperature detection mechanism is configured to provide the detected temperature of the heating element to the controller for controlling the source of energy. Watkins teaches a similar system comprising a controller (158), wherein a temperature detection mechanism is configured to provide a detected temperature of a heating element to the controller (note col. 4, line 53), and wherein the controller is configured to adjust the temperature of the heating element by controlling a source of energy (note col. 4, line 53). It is well known in the art that the use of temperature-based feedback (as taught by Watkins) would result in increased safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of McClurken (in view of Watkins) so that the temperature detection mechanism is configured to provide the detected temperature of the heating element to the controller for controlling the source of energy in order to increase safety and efficiency.
Response to Arguments
Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments concerning the cited references, Examiner respectfully disagrees. More specifically, Examiner maintains that the amended claims have been met by the cited references as they are currently written (at least partly due to their breadth), as can be seen in the updated rejections above. Therefore, Examiner asserts that the claims are still met by the cited references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 4,823,791 (D’Amelio).
THIS ACTION IS MADE FINAL. 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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/ Primary Examiner, Art Unit 3794
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