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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 09/21/2022. It is noted, however, that applicant has not filed a certified copy of the Chinese applications as required by 37 CFR 1.55.
Claim Objections
Claims 1, 2, 4, 7, 8, and 10 are objected to because of the following informalities:
Claim 1 recites “a first end of the central wire movably passing through” and “a first end of the resilient stent movably passing through”, although the lines do not rise to the level of being indefinite, as the lines are understood by the Examiner to be functional limitations and not recited as method steps in an apparatus claim, the Examiner suggests the lines be amended to read “a first end of the central wire configured to through” and “a first end of the resilient stent configured to move through” for the purpose of maintaining consistent language for an apparatus claim;
Claims 1 (lines 10,13), 5 (lines 2,3), 7 (line 7), 8 (line 2,3), and 10 (line 3,4) recites “the ultrasonic transducer”, although the lines are understood by the Examiner to mean “the at least one ultrasonic transducer” as previously defined, the Examiner suggests the lines be amended to read “the at least one ultrasonic transducer” for the purpose of maintaining consistent language throughout the claims;
Claim 2 recites “the resilient stent is formed into a mesh shape”, although the line does not rise to the level of being indefinite, as the line is understood by the Examiner to be functional limitation and not recited as a method step in an apparatus claim, the Examiner suggests the line be amended to read “the resilient stent is a mesh comprising a plurality of intertwined stent threads” for the purpose of maintaining consistent language for an apparatus claim;
Claim 4 recites “for any two adjacent ultrasonic transducers” in line 5, although the line is understood by the Examiner to mean “for any two adjacent ultrasonic transducers of the plurality of ultrasonic transducers” as the “ultrasonic transducers” were previously defined, the Examiner suggests the line be amended to read “for any two adjacent ultrasonic transducers of the plurality of ultrasonic transducers” for the purpose of maintaining consistent language throughout the claims;
Claim 7 recites “a cold medium periodically flows” in line 6, although the line does not rise to the level of being indefinite, as the line is understood by the Examiner to be functional limitation and not recited as a method step in an apparatus claim, the Examiner suggests the line be amended to read “a cold medium configured to periodically flow” for the purpose of maintaining consistent language for an apparatus claim;
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 3, 4, 7, and 8 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.
Regarding claims 3 and 4, the phrase "a plurality of ultrasonic transducers" renders the claim indefinite because it is unclear if Applicant is intending for the “plurality of ultrasonic transducers” (for each claim) to encompass the “u
Claim 7 recites the limitation "the cold medium supply" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 is rejected for being dependent on an indefinite claim.
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.
(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.
Claims 1, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pikus et al (US 2015/0105715 A1).
Regarding claim 1, Pikus discloses an ultrasonic ablation catheter (system 200) (title, abstract, paragraphs [0007], [0040], and Fig. 2), comprising:
a central cavity tube (guide sheath 222) with a central hole being provided along an axial direction of the central cavity tube (paragraph [0048] and Fig. 2);
a central wire (shaft 208) being provided with at least one ultrasonic transducer (transducer 210) (paragraph [0040] and Fig. 2), and a first end (distal end – end shown in Fig. 2) of the central wire (shaft 208) movably passing through the central hole, to switch between a contracted state (state when covered by the sheath 222) and an extended state (state shown in Fig. 2) (paragraph [0051]); and
a resilient stent (basket 212) (paragraph [0045]) being preformed into a set shape and being nested on the central wire (paragraph [0048] and Fig 2), and a first end (end 215) of the resilient stent movably passing through the central hole, to switch between a compressed state and an expanded state, wherein when the central wire is in the contracted state, the ultrasonic transducer and a second end of the resilient stent are accommodated in the central cavity tube together with a second end (end 213) of the central wire, for the resilient stent to be in the compressed state (Examiner’s note: as stated in paragraphs [0045] and [0048] the basket 212 (i.e., the stent) is affixed to the shaft 208 (i.e., the wire), is self-expandable, and is deployed (i.e., expanded) via the retraction of the sheath 222 (i.e., cavity tube); therefore, the basket 212 (i.e., the stent) is movably past the central hole (i.e., the distal opening of the sheath 222) to switch between the compressed state and the expanded state); and
when the central wire is in the extended state, the ultrasonic transducer and the second end of the resilient stent extend out of the central cavity tube together with the second end of the central wire, for the resilient stent to be in the expanded state and restore to the set shape (paragraph [0048] and Fig. 2).
Regarding claim 9, Pikus discloses further comprising a connecting member (retaining element 218) connected and fixed to the second end (end 215) of the resilient stent and the second end of the central wire (shaft 208) (paragraph [0045] and Fig. 2).
Regarding claim 11, Pikus discloses an ultrasonic ablation device (system 200) (title, abstract, paragraphs [0007], [0040], and Fig. 2), comprising the ultrasonic ablation catheter according to claim 1 (paragraphs [0040 – 0048] and Fig. 2).
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 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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Pikus et al (US 2015/0105715 A1), as applied to claim 1 above, and further in view of Sinelnikov (US 2014/0350401 A1).
Regarding claim 2, as discussed above, Pikus discloses the ultrasonic ablation catheter of claim 1.
However, Pikus is silent regarding (i) the resilient stent is formed into a mesh shape by intertwining a plurality of stent threads.
As to the above, Sinelnikov teaches, in the same field of endeavor, an ablation catheter comprising an ultrasonic transducer surrounded by an expandable structure (e.g., a balloon, cage, basket, mesh, or coil; which is equated to the basket 212 of Pikus) to position, align, or maintain stable position of the transducer in the vessel (abstract, paragraph [0247], and Figs. 20B,28C).
It should be understood that Pikus and Sinelnikov are known references in the art that teach an ablation catheter with an ultrasonic transducer surrounded by an expandable structure (title, abstract, paragraphs [0007], [0040], and Fig. 2 – Pikus ; abstract, paragraph [0247], and Figs. 20B,28C – Sinelnikov); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one expandable structure for another (i.e., a mesh for a basket), and the results of the substitution would have been predictable and resulted in the modified expandable structure of Pikus being able to function as intended to properly position/ provide stability to the transducer within the vessel. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Claims 5 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pikus et al (US 2015/0105715 A1), as applied to claim 1 above, and further in view of Cheung et al (US 2022/0378461 A1).
Regarding claims 5 – 7, as discussed above, Pikus discloses the ultrasonic ablation catheter of claim 1.
However, Pikus is silent regarding [claim 5] (i) a balloon wrapped around the ultrasonic transducer between the resilient stent and the ultrasonic transducer, [claim 6] (ii) a cooling pipe is disposed in the central hole, a first end of the cooling pipe is configured to be connected to a cold medium supply apparatus, and a second end of the cooling pipe extends out of the central cavity tube, to correspond to a position of the ultrasonic transducer when the central wire is in the extended state, and [claim 7] (iii) a first channel and a second channel communicated with each other are provided in the central wire, the first channel is configured to be communicated with a liquid outlet of the cold medium supply apparatus, and the second channel is configured to be communicated with a liquid inlet of the cold medium supply apparatus, to jointly form a cooling circulation loop; and a cold medium periodically flows in the cooling circulation loop, to cool the ultrasonic transducer.
As to the above, Cheung teaches, in the same field of endeavor, an ultrasonic ablation catheter (catheter 102) comprising a central cavity tube (catheter shaft 214) an inner wire (backing member 218), an ultrasonic transducer (transducer 111), a resilient stent (basket 290), a balloon (balloon 112) for centering the transducer within the body (paragraph [0125]), a cold media supply apparatus (cartridge 130 and reservoir 110) (paragraphs [0140 – 0141] and Fig. 3C), a first end of a cooling pipe / a first channel (fluid outlet path) and a second end of a cooling pipe / second channel (fluid inlet path) forming a cooling circulation loop wherein a cold medium periodically flows to cool the ultrasonic transducer (paragraphs [0142 – 0145] and Fig. 3C) (abstract, paragraphs [0031], [0092], [0098 – 0100], [0105], [0109], [0118], [0125], [0126], [0128], [0141], and Figs. 2B,2F,3C).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Pikus to incorporate a balloon, based on the teachings of Cheung, for the purpose of aiding in centering the transducer (paragraph [0125] – Cheung); and it would be obvious to modify the system of Pikus to incorporate the cooling system as claimed for the purpose of cooling the transducer and/or to protect non-target tissue (paragraphs [0113 – 0114]). Furthermore, it would be obvious to one of ordinary skill in the art to have the cooling pipe extending distally from the central cavity tube for the purpose of having the cooling pipe extend to the transducer; and/or it would be obvious to one of ordinary skill in the art to have the outlet channel (i.e., the first channel) and the inlet channel (i.e., the second channel) extend through the central wire for the purpose of having a more condensed system.
Regarding claim 8, as discussed above, the combination of Pikus and Cheung makes obvious the device of claim 7. Additionally, Pikus discloses the ultrasonic transducer is mounted on an outer side of the central wire by pasting and/or embedding to partially cover the central wire (paragraph [0041]), and the central wire is capable of rotating around an axial direction of the central wire in 360 degrees to drive the ultrasonic transducer to rotate in 360 degrees (Examiner’s note: the entire medical device is capable of being rotated, therefore, the central wire of Pikus is capable of being rotated).
However, the combination of Pikus and Cheung is silent regarding (i) the width of the ultrasonic transducer being less than a diameter of the central wire.
As to the above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pikus in view of Cheung to have the transducer have a width less than the diameter of the central wire since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the transducer of Pikus in view of Cheung would not operate differently with the claimed width and since the transducer is intended to reside on the central wire and only partially cover the outer diameter of the central wire then the transducer would function appropriately having the claimed width. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the width “may” be within the claimed ranges (specification pp. [0066]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pikus et al (US 2015/0105715 A1), as applied to claim 1 above, and further in view of Fuimaono et al (US 2004/0019349) and Fjield et al (US 2003/0050632 A1).
Regarding claim 10, as discussed above, Pikus discloses the ultrasonic ablation catheter of claim 1.
However, Pikus is silent regarding (i) the resilient stent is provided with a transparent region corresponding to the ultrasonic transducer and an opaque region and (ii) where the transparent region is a refractive region to refract ultrasonic waves emitted by the ultrasonic transducer.
As to (i), Fuimaono teaches, in the same field of endeavor, an ultrasonic ablation catheter (abstract, paragraphs [0035 – 0040], Figs. 5, ) comprising a central wire (inner support 30), an expandable member (balloon 26; which equates to the basket 112 of Pikus), surrounding a transducer (ablation element 28; which equates to the transducer 111 of Pikus) on the central wire (inner support 30); wherein the expandable member comprises an opaque region (regions covered via a filter 68) for the purpose of shielding non-targeted tissue from the ablation energy and a transparent region (region without the filter 68 – 70) that corresponds to the ultrasonic transducer for the purpose of allowing the ablation energy to flow to the targeted tissue (paragraphs [0098 – 0099] and Fig. 9A).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the resilient stent (basket 112) of Pikus to include opaque regions and a transparent regions, based on the teachings of Fuimaono, for the purpose of shielding non-targeted tissue from the ablation energy (paragraphs [0098 – 0099] – Fuimaono).
As to (ii), Fjield teaches, in the same field of endeavor, an ultrasonic ablation catheter comprising an ultrasonic transducer (transducer 20) on a central wire (catheter 16) (abstract, paragraph [0045], and Fig. 1), and an expandable member (balloon 28; which is equated to the basket 112 of Pikus) comprising a transparent region with a refractive element thereon for the purpose of focusing the ablation energy to a specific location (paragraph [0092]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the opaque region of Pikus in view of Fuimaono to add a refractive element to the transparent region for the purpose focusing the ablation energy of the transducer to the desired targeted location (paragraph [0092] – Fjield). Therefore, the modified device makes obvious the limitations of claim 10.
Allowable Subject Matter
Claims 3 and 4 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
McDaniel (US 2008/0086073 A1), Gross et al (US 2018/0250054 A1), and Matsukuma et al (US 2007/0149963 A1) teach an ablation catheters with a central wire within a central tube, a resilient stent, and an ultrasonic transducer.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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