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.
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for the related application. That is, the parent application is referenced as a U.S. application even though it has issued as a patent. The paragraph should be amended to include the appropriate patent number.
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, 20, 25-29, and 31-35 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 is found to be indefinite, because Examiner is unsure of the scope of the “power source” and “voltage regulator” limitations. More specifically, the scope of the entire claim is unclear, since it is unclear how these limitations are tied to the rest of the claim features. Appropriate correction is required.
Claim 18 recites the limitation "a detected temperature" in line 4. The antecedent basis for this limitation is confusing, since it appears as though it has already been recited. Appropriate correction is required.
Claim 20 is found to be indefinite, because Examiner is unsure of what is meant by the limitations “the heating element is configured to heat the thermal assembly” and “the heating element is configured to cool the thermal assembly”. More specifically, the scope of the entire claim is unclear, since this appears contradictory to the claimed/disclosed relationship between the ‘heating element’ and the ‘thermal assembly’. It appears as though the ‘thermal assembly should be configured to heat/cool the heating element’. Appropriate correction is required.
Claims 25-29 recite the limitation "the system" in line 1. There is insufficient antecedent basis for this limitation in the claims. It appears as though these limitations should be replaced with -the surgical device-.
Claims 31-35 recite the limitation "the system" in line 1. There is insufficient antecedent basis for this limitation in the claims. It appears as though these limitations should be replaced with -the hemostatic sealer-.
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, and 19-35 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 44-46) 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 substrate (note abstract), 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.
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 19, McClurken discloses (see above) a system wherein the heating element comprises a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite sides of the substrate, wherein electrical current is passed through the heating element between the set of tabs.
Regarding claim 20, McClurken discloses (see above; as best understood by Examiner) a system wherein the heating element 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 heating element 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’) and a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite ends of the double helical trace.
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 44-46) 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 substrate (note abstract), 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).
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 26, McClurken discloses (see above) a surgical device wherein the heating element comprises a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite sides of the substrate, wherein electrical current is configured to be passed through the heating element between the set of tabs.
Regarding claim 27, McClurken discloses (see above) a surgical device wherein the heating element comprises a ‘double helical trace’ (see ‘29a’ and ‘30a’) and a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite ends of the double helical trace.
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 44-46) 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 substrate (note abstract), 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.
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 32, McClurken discloses (see above) a hemostatic sealer wherein the heating element comprises a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite sides of the substrate, wherein electrical current is configured to be passed through the heating element between the set of tabs.
Regarding claim 33, McClurken discloses (see above) a hemostatic sealer wherein the heating element comprises a ‘double helical trace’ (see ‘29a’ and ‘30a’) and a set of ‘tabs’ (‘29’ and ‘30’) positioned on opposite ends of the double helical trace.
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, 26, 30, and 32 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 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.
Regarding claim 18, Watkins discloses (see above) a system further comprising a ‘power source’ (121), a controller (158), and a ‘voltage regulator’ (151) ‘coupled’ to both the power source and the controller, 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 a detected temperature of the heating element to the controller (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 19, Watkins discloses (see above) a system wherein the heating element comprises a set of ‘tabs’ (‘208’ – note col. 4, line 16) positioned on opposite sides of the substrate, wherein electrical current is passed through the heating element between the set of tabs.
Regarding claim 20, Watkins discloses (see above; as best understood by Examiner) a system wherein the heating element 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 heating element 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 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).
Regarding claim 26, Watkins discloses (see above) a surgical device wherein the heating element comprises a set of ‘tabs’ (‘208’ – note col. 4, line 16) positioned on opposite sides of the substrate, wherein electrical current is configured to be passed through the heating element between the set of tabs.
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 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.
Regarding claim 32, Watkins discloses (see above) a hemostatic sealer wherein the heating element comprises a set of ‘tabs’ (‘208’ – note col. 4, line 16) positioned on opposite sides of the substrate, wherein electrical current is configured to be passed through the heating element between the set of tabs.
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 further comprising a power source and a voltage regulator, said voltage regulator coupled to both the power source and the controller, wherein the temperature detection mechanism is configured to provide a detected temperature of the heating element to the controller for controlling the source of energy. Watkins teaches a similar system comprising a ‘power source’ (121), a controller (158), and a ‘voltage regulator’ (151) ‘coupled’ to both the power source and the controller, 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 the 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) to comprise a power source and a voltage regulator (said voltage regulator coupled to both the power source and the controller), wherein the temperature detection mechanism is configured to provide a detected temperature of the heating element to the controller for controlling the source of energy in order to increase safety and efficiency.
Conclusion
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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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794