DETAILED ACTION
A complete action on the merits of claims 1-9 follows below.
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 .
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 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.
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.
Claims 2-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mathematical expression without significantly more. The claims recite “wherein in a case where the driving frequency of the probe is denoted by f, the resonance frequency is denoted by fr, and an anti-resonance frequency is denoted by fa, a range of the driving frequency, within the impedance characteristic of the treatment start temperature of the probe alone, satisfies the following expression (1), 4fr - 3fa ≤ f < fr (1)/ (2), 2.5fr - 1.5fa ≤ f ≤ 1.5fr - 0.5fa (2)/ (3), f = 2fr - fa (3)”. This judicial exception is not integrated into a practical application because the claims do not include additional elements sufficient to amount to significantly more than the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because abstract ideas, laws of nature, and natural phenomenon "are the basic tools of scientific and technological work", the Supreme Court has expressed concern that monopolizing these tools by granting patent rights may impede innovation rather than promote it. See Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has also emphasized that an invention is not considered to be ineligible for patenting simply because it involves a judicial exception. Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)). See also Thales Visionix Inc. v. United States, 850 F.3d. 1343, 1349, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017) (“That a mathematical equation is required to complete the claimed method and system does not doom the claims to abstraction.”). Accordingly, the Court has said that integration of an abstract idea, law of nature or natural phenomenon into a practical application may be eligible for patent protection. See, e.g., Alice, 573 U.S. at 217, 110 USPQ2d at 1981 (explaining that “in applying the §101 exception, we must distinguish between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the building blocks into something more” (quoting Mayo, 566 U.S. at 89, 110 USPQ2d at 1971) and stating that Mayo “set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts”); Mayo, 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that the Court in Diamond v. Diehr found “the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,” but the Court in Gottschalk v. Benson “held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle”); Bilski v. Kappos, 561 U.S. 593, 611, 95 USPQ2d 1001, 1010 (2010) (“Diehr explained that while an abstract idea, law of nature, or mathematical formula could not be patented, ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.’” (quoting Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)) (emphasis in original)); Diehr, 450 U.S. at 187, 192 n.14, 209 USPQ at 10 n.14 (explaining that the process in Parker v. Flook was ineligible not because it contained a mathematical formula, but because it did not provide an application of the formula). See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972); Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978).
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 and 7 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). Claim 1 recites the limitation “an opening and closing mechanism that grips biological tissue” and Claim 7 recites the limitation “wherein the biological tissue is soft tissue including blood vessels”. Claim 1 positively claims biological tissue as opposed to functionally reciting the action and claim 7 also positively claims “soft tissue including blood vessels” which are excluded from the scope of patentable subject matter. Clarification and 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 1-9 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “a probe that includes a piezoelectric element; a power supply circuit for driving the piezoelectric element; a power supply wiring line to the piezoelectric element; a flexible tubular sheath; a control mechanism for the amount of power supplied to the piezoelectric element; and an impedance matching circuit, wherein the probe has electrode layers for power supply on both surfaces of the piezoelectric element and an opening and closing mechanism that grips biological tissue, the flexible tubular sheath includes the power supply wiring line to the piezoelectric element and a part of the opening and closing mechanism of the probe, and the impedance matching circuit sets a driving frequency used in the power supply to the piezoelectric element to a frequency lower than a resonance frequency in an impedance characteristic at a treatment start temperature of the probe and a frequency at which a reactance component of impedance becomes 0 Ω”. First, the claim is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: It is unclear how the probe, a piezoelectric element, a power supply wiring line, a flexible tubular sheath, a control mechanism and an impedance matching circuit are structurally related to one another. It is also unclear how and in what structural relationship the probe has electrode layers for power supply on both surfaces of the piezoelectric element. It is unclear the piezoelectric has two surfaces or more and how the electrode layers are provided on both surfaces. Moreover, it is unclear where an opening and closing mechanism are provided that grips biological tissue. Furthermore, it is unclear how and in what structural relation the flexible tubular sheath includes the power supply wiring line to the piezoelectric element and a part of the opening and closing mechanism of the probe. Finally, it is unclear how the impedance matching circuit sets a driving frequency used in the power supply to the piezoelectric element to a frequency lower than a resonance frequency in an impedance characteristic at a treatment start temperature of the probe and a frequency at which a reactance component of impedance becomes 0 Ω. Without claiming a processor, controller and/or user interface, it is unclear how the impedance matching circuit can “set” any frequency limits and how it determines the frequency such that it is a frequency lower than a resonance frequency in an impedance characteristic at a treatment start temperature of the probe and a frequency at which a reactance component of impedance becomes 0 Ω. It is also unclear what “an impedance characteristics” refers to. Clarification and appropriate correction is required.
Claim 9 recites the limitation “the maximum reaching temperature of the piezoelectric element is equal to or lower than the resonance frequency in the impedance characteristic at the treatment start temperature”. There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the maximum” is referring to since no maximum values have been introduced prior to this recitation. It is further unclear how this maximum reaching temperature of the piezoelectric element is found to be and/or set to be equal to or lower than the resonance frequency in the impedance characteristic at the treatment start temperature. Clarification and appropriate correction is required.
Claims 2-8 are rejected due to dependency over a rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites the limitation “wherein the biological tissue is soft tissue including blood vessels”. It is therefore unclear how this limitation further limits the surgical treatment apparatus of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1, 5-6 and 8-9 would be allowable if rewritten or amended 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.
As best understood in view of the 112 rejections above, the closest reference to Claim 1, Sinelnikov (US Pub. No. 2014/0350401) teaches a surgical treatment apparatus (“Axial Directed Energy (ADE) device 77 that directs energy in an axial direction from within a forceps catheter 73 configured for grasping or saddling upon an intercarotid septum” [0192], Fig. 10) comprising:
a probe (“an endovascular catheter, which may be steerable or used over a guide wire” [0185], “forceps catheter 73” [0192] Fig. 10) that includes a piezoelectric element (“Axial emitting sonodome 46 comprises a singular or an array of piezoelectric transducers configured for emitting ultrasonic energy at tissue ablating levels in an axial direction as depicted by ultrasonic energy emission cone 47” [0185], “catheter 52” [0186] Fig. 7, “ADE device is configured to deliver directed energy 78 between forceps arms 96. Forceps pads 75 provide an atraumatic bifurcation wall contact with a secure grasping force” [0192], “Catheter 207 can be equipped with a balloon 204 that is inflatable and can be filled with liquid that conducts ultrasound waves from an emitter that can be a piezoelectric crystal 202 that is the source of the ultrasonic waves and mechanical energy of ultrasound” [0215]);
a power supply circuit for driving the piezoelectric element ([0185], [0214]-[0215] and [0300]); a power supply wiring line to the piezoelectric element (“catheter 207 contains wires that conduct the excitation electric current to the emitter” [0215]);
a flexible tubular sheath (an endovascular catheter [0185], forceps catheter 73 Fig. 10, catheter 52 Fig. 7, catheter 205 Fig. 20, various figures show an endovascular flexible tubular sheath);
a control mechanism for the amount of power supplied to the piezoelectric element (“ablation depth can be controlled by varying the frequency at which the ultrasound is emitted. Additionally, the properties of the piezoelectric material used in the transducer effect the depth of ablation. In the embodiments herein, the transmitters are configured to emit high intensity ultrasound energy” [0214]); and
an impedance matching circuit (“transducer efficiency may be enhanced to reduce transducer self-heating by a means of electrical and acoustic impedance matching” [0251]),
wherein the probe has electrode layers for power supply on both surfaces of the piezoelectric element and an opening and closing mechanism that grips biological tissue (both tissue facing surfaces of the forceps configuration in Fig. 10 and “FIG. 29A shows an exemplary piezoelectric transducer element 150 with a top (or front) electrode 151 and bottom (or back) electrode 152” [0253]), the flexible tubular sheath includes the power supply wiring line to the piezoelectric element and a part of the opening and closing mechanism of the probe ([0192]), and the impedance matching circuit sets a driving frequency used in the power supply to the piezoelectric element (“ablation depth can be controlled by varying the frequency at which the ultrasound is emitted. Additionally, the properties of the piezoelectric material used in the transducer effect the depth of ablation” [0214])
although teaches “In some embodiments the effectiveness of a therapeutic high energy mode transducer operating in continuous mode at or near resonance frequency can be optimized by including a matching layer made of material with acoustical impedance lower than the acoustical impedance of soft tissue or water” in [0252], neither alone or in combination teaches the impedance matching circuit sets a driving frequency used in the power supply to the piezoelectric element to a frequency lower than a resonance frequency in an impedance characteristic at a treatment start temperature of the probe and a frequency at which a reactance component of impedance becomes 0 Ω.
Claims 5-6 and 8-9 depend on claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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