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 .
Information Disclosure Statements
The information disclosure statements (IDSs) filed June 12, 2025, August 21, 2024 and October 30, 2023 have been entered and the references cited therein have been considered by the examiner.
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 8 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 8 recites “the distal tip includes the hooked portion” when claim 1, from which claim 8 depends, recites the “hooked portion” in the alternative. For instance, if claim 1 is read as reciting a rounded distal end, “the hooked portion” would not have any relevance in claim 8 both because the rounded distal end is not disclosed as having a hooked portion and none of the other distal tips recited in claim 1 have a hooked portion as part of their elemental makeup. Thus, the recitation of “the distal tip includes the hooked portion” is vague and indefinite. Applicant should instead recite that the distal tip comprises a hooked portion.
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aldridge et al. (U.S. Patent No. 11,324,527).
In regard to claims 1-3, Aldridge et al. teach an ultrasonic surgical instrument 12 comprised of a handle assembly 12, an elongated shaft assembly 14, an ultrasonic transducer 16 and an end effector assembly 26 at the distal end of the elongated shaft assembly 14 (see Fig. 107). The ultrasonic transducer 16 is mechanically engaged to the elongated shaft assembly 14 and portions of the end effector assembly 25 and is electrically coupled to a generator 20 via cable 22 (see col. 14, lines 55-59). The generator 20 has an ultrasonic generator module 21 and an RF generator module 23 where the RF generator module 23 may be capable of supplying power to perform either bipolar or monopolar surgery (see col. 15, lines 4-51). The ultrasonic generator module 21 and the RF generator module 23 may be activated simultaneously (see col. 16, lines 48-67). The end effector assembly 26 includes a clamp arm assembly 64 (jaw member) and an ultrasonic blade 66 where the blade 66 is acoustically coupled to the ultrasonic transducer 16 (see Figs. 108-110 and col. 21, lines 13-19). Squeezing a trigger 32 in direction 33A moves the clamp arm assembly 64 in direction 62A from an open position, where the clamp arm assembly 64 and the blade 66 are disposed in a spaced relationship, to a clamped or closed position, where the clamp arm assembly 64 and the blade 66 cooperate to grasp tissue therebetween (see col. 21, lines 23-28). The clamp arm assembly 64 includes a clamp pad 69 (jaw liner) to engage tissue between the blade 66 and the clamp arm 64 (see col. 21, lines 29-31 and Figs. 108-110). Aldridge et al. teach various shapes for the distal tip of the blade 66, including a rounded distal tip (see Fig. 110) and a pointed edge facing away from the longitudinal axis of the blade 66 (see Figs. 115A-115D). In regard to claims 4-7, Aldridge et al. teach coating of the ultrasonic blade 5100 with an electrically insulative material 5102 to provide thermal insulation at the tissue contact area and to minimize adhesion of tissue to the blade 5100 (non-stick) (see Figs. 80-83 and col. 47, lines 29-32). Aldridge et al. disclose a lubricious coating 5102 similar to Telfon (see col. 47, lines 54-56). Aldridge et al. also teach that the blades may be partially coated (see Figs. 84-93) with coated portions 5202 and non-coated portions 5204 with a portion of the distal tip of the blade exposed (see col. 48, lines 3-24).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aldridge et al. (U.S. Patent No. 11,324,527) in view of Hood (U.S. Patent No. 6,254,622).
In regard to claim 8, as noted above, Aldridge et al. teach various shapes for the blade 66. Hood teaches an ultrasonic blade 12 having a distal tip with a hooked portion and a notch 22 proximally positioned with respect to the hooked portion (see Fig. 1). Hood thus demonstrates that ultrasonic blades with hooked portions having a notch were well known in the art for the purpose of creating an effective cutting action (see col. 2, lines 29-40). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Aldridge et al. with the hooked and notched blade of Hood as the blade 66 in order to provide a more effective cutting action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794