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.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, U.S. Provisional Patent Application No. 63/255,757 (which lacks a Specification), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the claims of this application.
The Examiner notes that support for the instant claims has only been found in the instant disclosure. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 10/14/2022, this being the filing date of the instant application.
Claim Objections
Claim 5 is objected to because of the following informalities: In line 1, “delivered” should be replaced with -supplied-. 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.
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 15-20 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 15 recites the limitation "the bracket member" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "an electrosurgical generator" in line 2 (also see line 3). The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “electrosurgical generator”.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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) 1, 3-10, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oron, U.S. 2016/0206882 (hereinafter Oron) in view of Partsch, U.S. 2014/0330068 (hereinafter Partsch).
Regarding claims 1 and 6, Oron discloses (note fig. 7) an electrosurgical device comprising: a ‘guide member’ (formed from ‘1254’ and ‘1264’) configured to be releasably fitted (note paragraph 174) to a portion of an ultrasound imaging transducer probe (1226); a ‘carriage member’ (1262) movably coupled to the guide member (note paragraph 172) and comprising at least one pair of needle probes (‘1260’ – note paragraph 154) configured to deliver therapeutic energy to tissue at a target site, the pair of needle probes extend from a ‘distal end’ of the carriage member and are movable (i.e., capable of being moved) between a fully retracted position in which a distal-most end of each needle probe does not extend past an operating distal end of the ultrasound imaging transducer probe and a fully deployed position in which the distal-most end of each needle probe extends past the operating distal end of the ultrasound imaging transducer probe and into tissue at the target site (note paragraph 173); and a power source (necessarily) supplying energy to the at least one pair of probes (note abstract; paragraph 154). While Oron discloses a device comprising a power source for stimulating nerves, Oron fails to explicitly disclose that this power source comprises an electrosurgical generator for supplying RF energy. Partsch teaches a similar device comprising a power source for stimulating nerves, wherein this power source may comprise an electrosurgical generator for supplying RF energy (note paragraph 35). It is well known in the art that a wide variety of energy modalities are widely considered to be interchangeable for this purpose (as can be seen in Partsch – note paragraph 35). 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 power source of Oron (in view of Partsch) to comprise an electrosurgical generator for supplying RF energy. This is because this modification would have merely comprised a simple substitution with a known energy modality in order to produce a predictable (and desirable) result (see MPEP 2143). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 3-5, Oron discloses (see above) an electrosurgical device that is capable of meeting the claimed functional limitations.
Regarding claims 7-8, Oron discloses (see above) an electrosurgical device comprising a pair of probes, but fails to explicitly disclose the spacing therebetween. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have further modified Oron accordingly, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Oron discloses (see above) an electrosurgical device comprising a pair of probes, but fails to explicitly disclose the thickness of each. It would have been an obvious matter of design choice to have further modified Oron accordingly, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 10, Oron discloses (see above) an electrosurgical device wherein the guide member necessarily comprises one or more ‘user-controlled inputs’ (at ‘1266’) for controlling movement (i.e., rotation) of the carriage member relative to the guide member (note paragraph 172).
Regarding claims 18-20, Oron discloses (see above; as best understood by Examiner) an electrosurgical device that is capable of meeting the claimed functional limitations (it should be noted that the ‘electrosurgical generator,’ and especially the ‘controller,’ are not positively recited by the language in these claims).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oron in view of Partsch as applied to claims 1, 3-10, and 18-20 above, and further in view of Lee, U.S. 2016/0045222 (hereinafter Lee).
Regarding claims 11-12, Oron discloses (see above) an electrosurgical device comprising guide and carriage members, but fails to explicitly disclose that these members are movably coupled to one another via a rack and pinion assembly. Lee teaches (note fig. 6) a similar device comprising ‘guide’ (see fig. 1D) and ‘carriage’ (see fig. 1C) members, wherein these members are movably coupled to one another via a rack member (‘68’ – defined on carriage member) and a pinion gear (‘77’ – defined on guide member). It is well known in the art that these different actuating configurations are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the apparatus of Oron (in view of Lee) so that the guide and carriage members would be movably coupled to one another via a rack and pinion assembly. This is because this modification would have merely comprised a simple substitution of interchangeable actuating configurations in order to produce a predictable result (see MPEP 2143).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oron in view of Partsch and Lee as applied to claims 11-12 above, and further in view of Hashimshony, U.S. 9,999,353 (hereinafter Hashimshony).
Regarding claims 13-14, Oron in view of Partsch and Lee teaches (see above) an electrosurgical device comprising guide and carriage members, wherein these members are movably coupled to one another, and wherein the guide member comprises a knob (8) operably associated with the pinion gear such that rotation of the knob/pinion causes subsequent curvilinear movement of the rack/carriage. However, this combination of references fails to expressly teach that the pair of probes are fixed to the carriage member, and that rotation of the knob/pinion causes subsequent linear movement of both the rack/carriage member and the probes. Hashimshony teaches (note figs. 14A-C; col. 14, line 64) a similar device comprising ‘guide’ (630) and ‘carriage’ (620) members that are movably coupled to one another via a rack and pinion assembly, wherein the guide member comprises a knob (1120) operably associated with a pinion gear such that rotation of the knob/pinion causes subsequent linear movement of both the rack/carriage member and a probe (600) that is fixed thereto. This design, which provides the user with increased control of probe movement, would necessarily 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 further modified the apparatus of Oron to comprise a guide member knob whose rotation causes subsequent linear movement of both the rack/carriage member and the probes, in order to increase safety and efficiency.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oron in view of Partsch, Lee, and Hashimshony as applied to claims 13-14 above, and further in view of Boudreaux, U.S. 8,939,974 (hereinafter Boudreaux).
Regarding claims 15-17, Oron in view of Partsch, Lee, and Hashimshony teaches (see above) an electrosurgical device comprising bracket/guide and carriage members, wherein these members are movably coupled to one another via a rack and pinion assembly. However, this combination of references fails to expressly teach that the bracket/guide member comprises a drive lever operably coupled with the pinion, and configured to move said pinion between states where it is engaged/disengaged with the rack. Boudreaux teaches (note col. 5, line 12; figs. 2 and 15) a device comprising a ‘drive lever’ (170) operably coupled with a pinion (see fig. 15), wherein the drive lever is configured to move said pinion between states where it is engaged/disengaged with a rack (i.e., between different drive system modes, wherein the disengaged state corresponds to ‘coarse’ movement of both the blade and jaws and the engaged state corresponds to ‘fine’ movement of just the blade). This design, which enables the use of two operating modes, and utilizes a single trigger to control the two different modes, would necessarily result in increased versatility 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 further modified the apparatus of Oron (in view of Boudreaux) to comprise a drive lever operably coupled with the pinion and configured to move said pinion between states where it is engaged/disengaged with the rack, in order to increase versatility and efficiency.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are either addressed below or rendered moot because they do not apply to the current rejections. Some of Applicant’s arguments rely on language solely recited in preamble recitations in the claims. When reading the preamble in the context of the entire claim, the recitation “electrosurgical device” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
As above, it should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, Examiner asserts that the claims have been met as they are currently written by the cited combination of references, as can be seen above.
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.
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