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 Statement
The information disclosure statement filed July 31, 2025 has been entered and the references cited therein have been considered by the examiner.
Preliminary Amendment
The preliminary amendment filed July 31, 2025 has been entered and made of record.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the handle 170 (Fig. 2C; para. 0056) and the hub 150 (Fig. 5; para. 0061) as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: the first element 110 (Fig. 1). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: controller in claims 1, 14, 16-18, 21, 23 and 27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-3, 5-8, 10, 14-18, 20, 21 and 23-27 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.
In claim 1, a “plurality of surgical instruments” is recited, followed by a recitation of “at least two surgical instruments.” These recitations are not equivalent in scope ad a plurality does not necessarily equate to at least two. In addition, “at least two working ends” is recited multiple times in claim 1 which relates to the recitation of “at least two surgical instruments” and not “a plurality of surgical instruments.”
In claims 18, 23 and 24, the phrase “and/or” renders the claims vague and ambiguous as the metes and bounds of the claims cannot be determined.
As claims 2, 3, 5-8, 10, 14-17, 20 and 21 depend from claim 1, they are likewise rejected. As claims 25-27 depend from claim 23, they are likewise rejected.
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.
Claim(s) 1-3, 5-8, 14-18, 20, 21 and 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCarlo et al. (U.S. Patent Application Publication No. 2010/0023002) in view of Brennan et al. (PCT Publication No. WO 2010/104752).
In regard to claims 1, 6, 7, 14, 23, 24, 26 and 27, DiCarlo et al. teach a tissue ablation system 10 comprised of a plurality of ablation probes 12 where each probe 12 has an array of electrode tines 32 carried by the distal end 28 of the probe shaft 26 (surgical tool at a working end) (see Figs. 2 and 3 and para. 0047). The electrode array 32 is deployable from the distal end 22 of a cannula 18 that overlies the probe shaft 26 (see para. 0049). Accordingly, when the electrode array 32 is deployed but before it is energized, it can perform the function of displacing tissue (see Figs. 3 and 11B). DiCarlo et al. teach that tissue impedance can be measured adjacent to the probe 12 (see para. 0072). A generator 14 is configured for generating RF power and is coupled to the probes 12 via a RF cables 13 from power multiplexor 16 (adaptor) and RF cable 15 between the power multiplexor 16 and the generator 14 (see Fig. 1 and paras. 0046 and 0052) and the power multiplexor 16 can be incorporated into RF generator 14 itself (see para. 0053). The power multiplexor 16 further comprises a switch device 59 comprising a plurality of switch elements 60 having an output terminal 66 coupled to an output connector 21 corresponding to each probe 12 (see Fig. 6). The power multiplexor 16 further comprises a control circuit 70 coupled to the control terminals 68 of switch elements 60 for controlling the timing of the switch elements 60 which controls the power to the probes 12 (see para. 0063 and Fig. 6). The use of sensed physiological feedback (such as tissue impedance) to the control circuit 70 allows the control circuit 70 to change the status of the switch device 59 thereby changing the power delivered to each probe 12 (see paras. 0069-0070). DiCarlo et al. are silent as to an accelerometer. However, Brennan et al. teach a similar surgical system having an accelerometer disposed on the probe tip and determining distances between objects using the accelerometer (see para. 0027). Brennan et al. thus demonstrate that the use of an accelerometer on a probe tip to determine distances between objects (such as adjacent probes) is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to equip the probes 12 of DiCarlo et al. with accelerometers in order to be able to measure the distances between the probe tips 12. Figure 11B of DiCarlo et al. shows that the current is delivered when the target tissue is positioned between the tip ends of the probes 12. Brennan et al. also teach the use of two probes where the probes have different structures and functions. In regard to claim 2, see para. 0051 of DiCarlo et al. In regard to claim 3, see Fig. 7 and paras. 0051 and 0074-0076 of DiCarlo et al. In regard to claim 5, see para. 0052 of DiCarlo et al. In regard to claim 8, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide more than one power multiplexor 16, 116 as it is well settled that duplication of parts is an obvious modification. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). With further respect to claim 14 and in regard to claim 15, Brennan et al. do not disclose a cutoff distance. However, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that having the probes 12 of DiCarlo et al. too close to each other is counterproductive (would char or overheat the target tissue) and thus a cutoff distance, such as 5 mm, would be utilized. In regard to claims 21 and 25, see para. 0099 of DiCarlo et al. In regard to claim 16, see paras. 0069 and 0072 of DiCarlo et al. In regard to claim 17, see para. 0051 of Brennan et al. In regard to claim 18, see paras. 0090-0091 of DiCarlo et al. In regard to claim 20, see para. 0068 of DiCarlo et al.
Allowable Subject Matter
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant should not the following prior art references teaching systems with multiple surgical instruments: Jayme et al., U.S. Patent Application Publication No. 2019/0274750; Coulson et al., U.S. Patent Application No. 2015/0032100; Zada, U.S. Patent No. 9,433,458 and Weiner et al. U.S. Patent No. 11,033,322.
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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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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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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