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 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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a person of ordinary skill in the art. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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.
Claim(s) 98 and 103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richter (US 2008/0294037A1) in view of Ramakrishna et al. (US 2017/0215837A1, “Ramakrishna”).
Regarding claim 1, Richter discloses an endovascular apparatus for crossing through an obstruction in a blood vessel. The apparatus includes an electrically-driven source (50) transmits energy to a transducer that generates ultrasonic energy [0025, 0035, 0045]. A coupling (41, 42) is capable of exciting an endovascular wire (30), in use, to transmit ultrasonic energy along the wire from the source thereby coupled to the wire to an active tip (92) at the distal end of the wire. However, Richter does not disclose a signal acquisition and processing system configured to capture and respond to operational parameters of the apparatus as the active tip approaches or crosses through an obstruction in use, monitor variations in frequency of vibration of the wire via the coupling, and infer displacement of the active tip of the wire from waveforms in the wire determined from said variations in frequency of vibration of the wire.
In the same field of endeavor, wires using energy to travel through obstructions, Ramakrishna teaches a guidewire (100) having an acoustic sensor (122; [0069]) disposed at any point desired along the length of the guidewire. The sensor differentiates between different lesions based on the sound waves received when the distal tip (120) of the guidewire comes into contact with lesions and/or FFR (fractional flow reserve-a procedure to measure sever blockages). The guidewire includes a signal processing system in communication with the sensor [0070]. The signal processing system analyzes the frequency (variations in vibrations/sound) and amplitude of the sound waves (capture and respond to operational parameters of the apparatus as the active tip approaches or crosses through an obstruction in use), provides information regarding the occlusion, displays alphanumeric information and other characteristics (monitor variations in frequency of vibration of the wire via the coupling, infer displacement of the active tip of the wire from waveforms). It is noted that ultrasound is a type of sound wave above 20kHz. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the ultrasonic energy of Richter with a signal processing system in communication with a sensor that is configured to capture and respond to operational parameters of the apparatus as the active tip approaches or crosses through an obstruction in use, monitor variations in frequency of vibration of the wire via the coupling, and infer displacement of the active tip of the wire from waveforms in the wire determined from said variations in frequency of vibration of the wire, as taught by Ramakrishna, to provide means for differentiating between different lesions and obstructions.
Allowable Subject Matter
Claims 99-102 and 104-111 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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. Ranucci et al. (US 6,695,782) discloses an ultrasonic tissue device including a wire coupled to vibrating means.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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