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.
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: “the torque protection mechanism is configured to prevent…” in claims 1-14.
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 Objections
Claims 2 and 3 are objected to because of the following informalities: “each of the probe tip control cables” in line 2 of claim 2 should state “each of the plurality of probe tip control cables”. 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 1-14 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 1 is directed to “a device for torque protection in an instrument to be articulated”; however, dependent claims 2-13 are directed to “the transesophageal transducer”.
Claim 1 recites the limitation "the probe tip control cable" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-13 recites the limitation "the transesophageal transducer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “a plurality of probe tip control cables” in line 1. It is unclear as to whether “a plurality of probe tip control cables” includes “the probe tip control cable” of claim 1 or if it is a separate “probe tip control cable”.
Claim 2 recites the limitations “the transesophageal handle”, "the transesophageal probe tip" and “the probe tip” in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 discloses “comprising a torque protection mechanism”. It is unclear as to whether this is the same as “a torque protection mechanism” as set forth in claim 1 or if it is an additional mechanism.
Claims 4 and 5 discloses “at least one probe tip control cable”; however, claim 1 discloses “the probe tip control cable” not “at least one”.
Claims 4 and 5 recites the limitation "the probe tip" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the patient’s tissue" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The term “approximately 0.3 Nm” in claim 8, “approximately 0.4 Nm” in claim 9 and “approximately 0.3 Nm and 0.4 Nm” in claim 10 are relative terms which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term "approximately" is a relative term for which the written description has not provided upper and lower bounds.
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) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takayuki (JP2003339630).
Regarding claim 1, Takayuki discloses a device for torque protection in an instrument to be articulated, the device comprising:
a handle (operating unit 12 - fig.1);
an articulation control attached to the handle (knob 20 – fig.2);
an articulated tip (tip 23 – fig.1);
a control cable extending from the handle to the articulated tip, wherein the control cable transmits force to the articulated tip, the force generated in response to movement of the articulation control, the force to cause at least one of rotation and flexing of the articulated tip in one or more directions (bending the bending portion in the forward and reverse directions via the driving wire – claim 7);
a torque protection mechanism positioned between the handle and the probe tip control cable, wherein the torque protection mechanism is configured to prevention rotation or flexing of the instrument at a threshold pressure, wherein the torque protection mechanism is a breakaway torque component (when an excessive tensile force is applied to the bending operation wire W1 for some reason, the thin wire connecting member 35a, which has the weakest strength in the extension of the bending operation wire W1, is formed. Diameter bridge 35a is broken – p.5, last two paragraphs).
Regarding claim 2, Takayuki discloses a plurality of probe tip control cables extending from the handle to the probe tip, each of the probe tip control cables controlling a different flexing of the probe tip (driving wires – p.3, last paragraph, driving wires 31a and 31b – fig.4; a first knob 20a for lateral bending and a second knob 20b for vertical bending – p.3, paragraph 8). Examiner notes “the transesophageal handle” and “the transesophageal probe tip” have not been positively recited and do not provide any further patentable weight. In view of the lack of positive recitation, this limitation is considered a typographical error which is intended to state “the handle” and “the articulated tip” as set forth in claim 1.
Regarding claim 3, Takayuki discloses each of the plurality of probe tip control cables comprising a torque protection mechanism (driving wires 31a and 31b and small diameter bridging portion 35a and 35b – fig.4).
Regarding claim 4, Takayuki discloses wherein the at least one probe tip control cable control anteflexion and retroflexion of the probe tip (a first knob 20a for lateral bending and a second knob 20b for vertical bending – p.3, paragraph 8).
Regarding claim 5, Takayuki discloses wherein the at least one probe tip control cable controls flexing of the probe tip to the right and to the left (bending operation mechanism for the left and right directions – p.7, paragraph 3).
Regarding claim 6, Takayuki discloses wherein the breakaway torque component is attached to the control cable (when an excessive tensile force is applied to the bending operation wire W1 for some reason, the thin wire connecting member 35a, which has the weakest strength in the extension of the bending operation wire W1, is formed. Diameter bridge 35a is broken – p.5, last two paragraphs).
Regarding claim 7, Takayuki discloses wherein the torque protection mechanism is preset to prevent torque above a predetermined measurement for the threshold pressure, the predetermined measurement configured to prevent damage to the patient’s tissues (when an excessive tensile force is applied to the bending operation wire W1 for some reason, the thin wire connecting member 35a, which has the weakest strength in the extension of the bending operation wire W1, is formed. Diameter bridge 35a is broken – p.5, last two paragraphs).
Allowable Subject Matter
Claims 8-14 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571)272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797
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