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 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 27-32 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 14 now recites “the radiofrequency ablation device further comprising a sensor arranged on the electrode, wherein the sensor is connected to the electrical connector through a sensor lead which is located between the outer tube and the inner tube.” Each of claims 27-32 that depend either directly or indirectly from claim 14 recite “further comprising a sensor arranged on the electrode, wherein the sensor is connected to the electrical connector through a sensor lead which is located between the outer tube and the inner tube.” It is unclear whether the second recited “a sensor” is the same or different sensor than the one previously recited in claim 14. The examiner will examine the claims taking the position that there is only one sensor being claimed (that of claim 14). Clarification is requested.
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.
Claim(s) 14-24 and 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (CN112754650, hereinafter Wang) in view of Chang et al (US2006/0004286, hereinafter Chang).
As best understood based on the translation of Wang et al provided herein, regarding claim 14, Wang discloses an intra atrial septum ostomy system (100) that reads on the claimed radiofrequency ablation device, comprising: an electrode (60) in a shape of a mesh, which has a contracted state (4/11 in the Detailed Description section of the translation) that shrinks together under restriction and an expanded state that automatically expands outward without restriction, and is connected to an external electrical connector (56) through an electrode lead (278); a balloon (224) located at an inner side of the electrode, which pushes against the electrode when it is in an expanded state; a delivery tube comprising an outer tube (54) and an inner tube (55), the electrode lead is located between the outer tube and the inner tube (28 in the Detailed Description section of the translation), the delivery tube further comprises a balloon catheter communicating with one end of the balloon, which is located at the inner side of the inner tube and has a gap with the inner tube (Fig.4). Wang does not disclose the radiofrequency ablation device further comprising a sensor arranged on the electrode, wherein the sensor is connected to the electrical connector through a sensor lead which is located between the outer tube and the inner tube. In an analogous electrosurgical probe device, Chang teaches the desirability of mounting sensors on the distal end of the instrument shaft to be inserted into the patient’s body (para. 0016). Chang further shows sensors (16) on the electrodes having leads (14) that extend between an inner tube (102a) and outer tube (100a) [see Figures 4E and 4F]. This is advantageous to keep the electrical components safe and out of the way of any procedure being performed. It would have been obvious to one having ordinary skill in the art to place a sensor on the electrode of Wang and have the leads to said sensor extend between an inner and an outer tube of the probe as taught by Chang in order to allow for a sensor inserted into the body to have the leads protected from the environment and to prevent them from interfering with the medical procedure.
Regarding claim 15, the electrode of Wang is formed of Nickel alloy (111) which is a well-known memory alloy. The recitation of “by cutting a memory alloy” is regarded as a product-by-process limitation. “{E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claims 16-18, the electrode (21) is provided with an ablation zone (60), which is located on a raised part of the electrode; the raised part comprises an end of the electrode; the ablation zone is located on the end of the electrode; and, wherein a free end of the electrode extends outward, all as broadly as claimed. The examiner interprets the outer edge as an ‘end’ as broadly as claimed and as shown below by arrow.
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Regarding claim 19, Wang further shows a distance between the free end of the electrode and a central axis of the electrode is smaller than the distance between the raised part and the central axis of the electrode or smaller than a radius of a bronchus. The raised portion shown in heavy black above sits on the outer end of the electrode and therefore is further away from the central axis than the unraised portion of the electrode.
Regarding claims 20-21, Wang teaches the free end of the electrode is provided with several anti-scratch structures (shown in Fig. 1, labeled as 2532 in Fig 5), wherein each of the anti- scratch structures is provided with a small hole (2535) and a connecting line passes through adjacent small holes in turn to form a spacing ring.
Regarding claim 22, Wang teaches the balloon (224), when inflated, has a diameter greater than the diameter of the electrode at a point where the balloon abuts against the electrode (Fig. 4), suitable for pushing the electrode toward an inner wall of a bronchus.
Regarding Claim 23, Wang discloses the invention of claim 14 as discussed, supra. In a separate embodiment, Fig. 13, Wang discloses an alternative coolant flow path through micropores 220 directly in the balloon. It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have additional fluid flow directly through the balloon in order to better cool the tissue as it is ablated.
Regarding claim 24, the balloon catheter of Wang is provided with an input cavity (550) adapted to input coolant into the balloon, and an output cavity adapted to provide a passage for the coolant to flow out (22) of the balloon.
Regarding claims 27-32, in light of the 112 (b) rejection, supra, the limitations are met by Chang as discussed above with respect to claim 14.
Claim(s) 26 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (CN112754650, hereinafter Wang) in view of Chang et al (US2006/0004286, hereinafter Chang) and further in view of Waldstreicher et al (US 2021/0146126).
Regarding claims 26 and 33, Wang discloses the instant invention as discussed, supra. Wang further comprises a negative plate; a radiofrequency device, electrically connected to the negative plate and connected to the electrical connector; a pressure pump, connected to a balloon connector through a first butt tube; a circulating pump, connected to a coolant connector through a second butt tube as required in claims 26 and 33.
Wang does not discuss the ablative device for use for a bronchus with a bronchoscope.
Waldstreicher et al discloses an analogous ablation device having a mesh style electrode and balloon application and teaches its specific use in the bronchus with a bronchoscope (Fig. 8). Waldstreicher et al further discusses the benefits of an endoscopic visualization device (10314). It is further well known to provide an endoscope with multiple working channels to accommodate for all necessary instrumentation.
Waldstreicher et al further discusses the beneficial use of sensors ({] 0318) to monitor temperature throughout the bronchial procedure so as to prevent damage to the tissue and harm to the patient. Waldstreicher et al further envisions the placement of the sensors in any suitable location (10412). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the device of Wang with a bronchoscope in the area of the bronchus to effectively treat the bronchus. In addition, it would have been obvious to add sensors as desirably taught by Waldstreicher et al in order to most effectively protect the patient from injury or tissue damage.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDA C DVORAK whose telephone number is (571)272-4764. The examiner can normally be reached Monday-Friday 7 am-4 pm EST.
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LINDA C. DVORAK
Supervisory Patent Examiner
Art Unit 3739
/LINDA C DVORAK/Primary Examiner, Art Unit 3794