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 .
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: control mechanism that controls an amount of power supplied to the piezoelectric element AND stress concentration structure (aka, a structure for concentration stress) in claim 1. These correspond to a structural controller or processor at [0043] and to an elongate protruding structure from the jaw surface at [0041].
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the claim recites “biological tissue” in a manner which positively recites the biological tissue instead of functionally reciting it, such as “grip pieces that grip a biological tissue”. Thus, the claim positively recites a portion of a human organism, contravening 101 and AIA 33(a). It is suggested to amend this limitation to “grip pieces that are configured to grip a biological tissue” to overcome this rejection.
Claims 2-10 inherit the deficiency by virtue of their dependency on base claim 1.
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)(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) 1-3, 5-6, and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0258487 A1 to Jinbo et al. (hereinafter “Jinbo”) (cited in an IDS dated 01/05/2026).
Regarding claim 1, Jinbo discloses (see abstract; Figs. 1-23; and [0038]-[0127]) a surgical treatment device (as shown in the Figures) comprising: a treatment tool (1) including a transducer including a piezoelectric element (30) (see [0059]); an impedance matching circuit (104) for driving the piezoelectric element (see [0079]/[0082]); a power supply wiring line (31) that supplies power to the piezoelectric element (see [0054]); and a control mechanism (102, a controller which corresponds under 112(f) to the structure in the spec. for performing the function) that controls an amount of the power supplied to the piezoelectric element (see [0079]-[0083]), wherein the transducer is located at a distal end of the treatment tool (see Fig. 2 and [0060]-[0061]) and includes an opening/closing mechanism (12) that opens and closes grip pieces that grip a biological tissue (see Fig. 1 and [0044]), the piezoelectric element is installed on at least one of the grip pieces (see Fig. 2 and [0060]/[0061]), a stress concentration structure (25, an elongate structure protruding from the jaw surface which corresponds under 112(f) to the structure in the spec. for performing the function) is provided on at least one of the grip pieces (see Fig. 2 and [0055]-[0058]), the impedance matching circuit drives the piezoelectric element by using a first driving frequency and a second driving frequency that are frequencies different from each other (see [0078]-[0088]), and the piezoelectric element is driven by using the first driving frequency in a case in which the biological tissue is sealed ("hemostatic", [0088]), and is driven by using the second driving frequency in a case in which the biological tissue is incised ("dissection", [0088]) (see [0077]-[0078]).
Jinbo further discloses (claim 2) wherein the first driving frequency is a resonance frequency derived from a thickness dimension of the piezoelectric element, and the second driving frequency is a resonance frequency derived from a length dimension of the piezoelectric element (see [0100]-[0106]); (claim 3) wherein a frequency of the first driving frequency is in a range of 1 MHz or more and 10 MHz or less, and a frequency of the second driving frequency is in a range of 1 kHz or more and 1 MHz or less (see [0097]-[0098]); (claim 5) wherein power supply at the second driving frequency is executed in a second set period, and the grip is released in response to an end of the second set period (see [0078]-[0088], at the end of the dissection of the tissue, the jaws are understood to release and let go of the grip on the tissue because the procedure is complete); (claim 6) wherein switching from the first driving frequency to the second driving frequency is executed in a state in which the grip is maintained (see [0078]-[0088], there is no indication that the jaws must release the tissue prior to switching to the second frequency so it is understood that the jaws would remain gripped on the tissue); (claim 8) wherein during power supply at the first driving frequency, pressurization is performed such that a grip strength of the transducer becomes stronger than a grip strength at a start of the grip (see [0078]-[0099], this is an intended use or functional limitation and does not limit the structure of the apparatus in anyway - see MPEP 2114, the user is fully capable of progressively squeezing the actuator of the device to increase the pressure of the grip strength during the procedure if desired); (claim 9) wherein a grip strength of the transducer is controlled in a stepwise manner by a manual operation of a user (see [0078]-[0099], this is an intended use or functional limitation and does not limit the structure of the apparatus in anyway - see MPEP 2111-34, the user is fully capable of squeezing the actuator of the device in a stepwise manner to increase the pressure of the grip strength during the procedure if desired); (claim 10) wherein the stress concentration structure is linearly disposed from a vicinity of a distal end of the transducer toward the opening/closing mechanism, and is parallel to a longitudinal direction of the transducer (see Fig. 1).
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.
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) 4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jinbo in view of US 2010/0036405 A1 to Giordano et al. (hereinafter “Giordano”) (cited in an IDS dated 01/05/2026).
Jinbo discloses the invention substantially as claimed as discussed above, however, with respect to claim 4, Jinbo fails to specifically disclose wherein power supply at the first driving frequency is executed in a first set period in response to detection of the grip of the transducer. Further, with respect to claim 7, Jinbo fails to specifically disclose wherein the switching from the first driving frequency to the second driving frequency is automatically executed in response to an end of power supply at the first driving frequency. Giordano discloses (see abstract; Fig. 1; and [0029]-[0116]), in the same field of endeavor, a surgical treatment device comprising a treatment tool (100) including a transducer (50) including a piezoelectric element (see [0034]), a control mechanism that controls an amount of power supplied to the piezoelectric element (see [0034]), an opening/closing mechanism that opens and closes grip pieces (60/79) that grip a biological tissue (see Fig. 1 and [0040]), the piezoelectric element is driven using a first driving frequency and a second driving frequency that are frequencies different from each other (see [0060]-[0061]), wherein power supply at the first driving frequency is executed in a first set period in response to detection of the grip of the transducer (see [0061]-[0064]), wherein the switching from the first driving frequency to the second driving frequency is automatically executed in response to an end of power supply at the first driving frequency (see [0061]-[0064] and [0077]-[0079]) for the purpose of automating the transition from the first driving frequency to the second driving frequency sensing the impedance of the transducer as a function of the load on the blade caused by the gripped tissue in order to automatically switch to the second frequency when an impedance threshold is met (see [0062]-[0063]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Jinbo's device with the automated frequency transition mechanism taught by Giordano in order to automate the transition from the first driving frequency to the second driving frequency sensing the impedance of the transducer as a function of the load on the blade caused by the gripped tissue in order to automatically switch to the second frequency when an impedance threshold is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing ultrasonic devices operating at two different frequencies for performing different functions on tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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