DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 06/29/23.
The examiner acknowledges the amendments to the claims and specification.
Claims 1-9 are pending in this application.
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 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites in the last clause “wherein the conveying steel catheter conveys the separation point to a location of a hemangioma, and an external implant connected to the separation point is conveyed into a hemangioma cavity, the electrical separator is turned on, the electrical separator is turned on, the second anode and the second cathode connect the positive path and the negative path by means of electrolyte in blood to form a low-resistance circuit, and the separation point is electrochemically dissolved and fractured to be separated from an implant, and the implant remains within the hemangioma cavity.” It is unclear if these limitations are functional claim language and whether or not “an external implant” is being positively recited, since the preamble recites “a conveying apparatus” (i.e. capable of conveying an external implant).
For examination purposes, the limitation in claim 1 will be read as functional claim language and positively reciting the external implant, and instead read as:--wherein the conveying steel catheter is capable of conveying the separation point to a location of a hemangioma, and an external implant connected to the separation point is capable of being conveyed into a hemangioma cavity, such that when the electrical separator is turned on, the second anode and the second cathode connect the positive path and the negative path by means of electrolyte in blood to form a low-resistance circuit, and the separation point is electrochemically dissolved and fractured to be separated from the implant, and the implant remains within the hemangioma cavity--.
Claims 2-9 are rejected due to their dependency on Claim 1.
Claim 2, lines 2-3 recite “wherein the conveying steel catheter is a taper-grinding stainless steel catheter or nickel-titanium catheter”. It is unclear how a steel catheter can also be a nickel-titanium catheter, since steel does not comprise nickel-titanium.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ford et al., hereinafter “Ford” (U.S. Pub. No. 2009/0062726), cited in IDS filed 06/29/2023.
Regarding claim 1, Ford discloses a conveying (delivery) apparatus capable of realizing rapid electrical separation (see abstract), comprising:
a conveying conductor 94 (Figure 5; [0085]), wherein a proximal end of the conveying conductor is coated with an insulative material (Id.) and connected to a first cathode 102 (which serves as a cathodic, or negative terminal 30 as in Figure 1; [0090]-[0091]) of an external electrical separator 16 (Figure 1; [0063]);
a conductive catheter 98 (Figure 5; [0089]) sleeved on an outer side of the insulative material (Id.), wherein the conductive catheter is connected to a first anode (Id.; proximal end of hypotube 98 serves as an anodic, or positive terminal 28 as in Figure 1) of the electrical separator 16;
a support spring 92 (Figure 5; [0084]) connected to a distal end of the conveying conductor (via 88);
a second cathode 86 ([0079]) located at a distal end of the support spring;
a cathode conductive wire 88 (Figure 5; [0085]) having a proximal end (electrically) connected to the proximal end of the conveying conductor 94, a distal end of the cathode conductive wire is connected to the second cathode 86, and the second cathode, the cathode conductive wire and the conveying conductor form a negative path (return electrical path; [0090]) of the electrical separator 16;
a second anode 20 (Figure 5; [0078]) located at a distal end of the second cathode, wherein the second anode is provided with a separation point (severable portion of joint 20); and
an anode conductive wire 80 (Figure 5; [0076]), wherein a proximal end of the anode conductive wire is connected to the conductive catheter 98 ([0089]), a distal end 83 of the anode conductive wire penetrates through the distal end of the support spring 92 (Figure 5) and is connected to the second anode 20, and the second anode, the anode conductive wire and the conductive catheter form a positive path (forward electrical path; [0089]) of the electrical separator 16;
wherein the conveying conductor is capable of conveying the separation point to a location of a hemangioma (the apparatus is capable of being delivered in vasculature), and an external implant 22 (Figures 1 and 5, [0060]) connected to the separation point (of joint 20) is capable of being conveyed into a hemangioma cavity, such that when the electrical separator 16 is turned on, the second anode 20 and the second cathode 68 connect the positive path and the negative path by means of electrolyte in blood to form a low-resistance circuit, and the separation point is electrochemically dissolved and fractured to be separated from the implant, and the implant remains within the hemangioma cavity ([0006], [0063]).
However, Ford does not disclose the conveying conductor being a conveying steel catheter with a proximal end provided with a grinding part, an outer side of the grinding part is sleeved with an insulating catheter (instead of insulative coating material over a wire), and the cathode conductive wire inserted in the conveying steel catheter, wherein a proximal end of the cathode conductive wire is connected to the proximal end of the conveying steel catheter, and the anode conductive wire inserted in the conveying steel catheter.
In another embodiment of Ford, as shown in Figure 10, a conveying conductor can be in the form of a conveying catheter 498. It would have been obvious to one of ordinary skill before the effective filing date to modify the conveying conductor to be a conveying catheter, since Ford teaches in [0017] that instead of conveying conductor wire 94, a sheath or catheter may be utilized to advantageously increase the conductance of the electrically conductive path between the terminal and the severable joint or return electrode. Although Ford does not teach the conveying catheter being steel, Ford teaches that a suitable electrically conductive material is stainless steel ([0076]) and in another embodiment, a conveying catheter 299 made of steel ([0110]). It would have been obvious to one of ordinary skill to modify the conveying catheter to be steel since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. It is also noted that when the modification is made such that the conveying conductor wire 94 is a conveying steel catheter, the anode conductive wire 80 in Figure 5 would be inserted in the conveying steel catheter, as it runs through the center of the apparatus and is positioned radially inward of the conveying conductor 94 (also see anode conductive wire 481 inserted in conveying catheter 498 in Figure 10).
Furthermore, when the conveying conductor is modified to be a conveying steel catheter, instead of the insulative coating material as discussed above, an insulating catheter may be used as a sleeve to fully insulate the conveying catheter, as taught by ([0028], [0086]) which would maintain insulation of the return/negative path. Also, Ford teaches in Figure 8 a conveying element 380 proximal end provided with a grinding part (as in ground, tapered, or reduced in diameter), with an insulative catheter 396 disposed over the grinding part ([0122]). It would have been obvious to one of ordinary skill before the effective filing date to modify the conveying steel catheter with a grinding part sleeved with an insulating catheter, in order to facilitate connection between the conveying steel catheter and the insulating catheter and provide flexibility to facilitate passing through a curved body lumen or tortuous vasculature, while also electrically insulating the return electrical path.
Additionally, Ford teaches in another embodiment, shown in Figure 7, a cathode conductive wire 294 inserted in a conveying catheter 99, wherein a proximal end of the cathode conductive wire is connected to the proximal end of the conveying steel catheter. It would have been obvious to one of ordinary skill before the effective filing date to modify the conductive wire 88 (Figure 5) to instead be inserted and connected to the proximal end of the conveying steel catheter, as taught in Figure 7, since doing so would be since doing so would be substitution of one known conductive wire for another, which would yield predictable results, namely forming an electrically conductive bath extending between a terminal proximal end and a distal end of the conveying apparatus. See MPEP 2143.
Regarding claim 2, Ford as modified teaches the conveying steel catheter is a taper-grinding stainless steel catheter ([0076], [0110]) or nickel-titanium catheter, as discussed above, but does not expressly teach the conveying steel catheter having a diameter of 0.3mm to 0.6mm. However, in [0110] Ford teaches a conveying steel catheter 299 having a diameter of 0.012 inches (0.3 mm). It would have been obvious to one of ordinary skill before the effective filing date to modify the diameter of the conveying steel catheter to be 0.3mm to 0.6mm, 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 modified device of Ford would not operate differently with the claimed diameter range. Further, the Applicant places no criticality on the range claimed, stating that the diameter of the stainless steel catheter “preferably” is 0.3 mm to 0.6 mm (present application publication; [0015]).
Regarding claim 3, Ford as modified teaches the second anode 20 is a stainless steel wire ([0082]), except does not teach the second anode having a diameter of 0.02mm to 0.08mm. However, one of ordinary skill in the art would acknowledge that the diameter of the second anode, or severable joint 20 is a result effective variable which could be optimized to decrease the detachment time of the implant at the separation point ([0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the second anode to have a diameter of 0.02mm to 0.08mm since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Ford as modified teaches the claimed invention, as discussed above, including the anode conductive wire 80 externally provided with an insulating layer ([0076]) and the cathode conductive wire 88 being a noble metal wire and externally provided with an insulating layer ([0079;] 88 [part of 86] can be made of silver and coated with an electrically insulative material). However, Ford as modified does not teach the anode conductive wire also being a noble metal alloy wire, and diameters of the anode conductive wire and the cathode conductive wire being both within a range of 0.05mm to 0.1mm. It would have been obvious to one of ordinary skill to modify the anode conductive wire to be a noble metal alloy wire, since noble metals are old and well known in the art for being advantageously resistant to corrosion and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. Additionally, in [0085] Ford teaches a conductor wire 94 has a wire diameter being 0.0015 inches (0.04 mm). It would have been obvious to one of ordinary skill before the effective filing date to modify the anode conductive wire and the cathode conductive wire diameters to be within a range of 0.05mm to 0.1mm, 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 modified device of Ford would not operate differently with the claimed diameter range. Further, the Applicant places no criticality on the range claimed, stating that the diameter of the anode and cathode conductive wires are is 0.05mm to 0.1mm (present application publication; [0017]).
Regarding claim 5, Ford as modified teaches the second cathode is ring-shaped or spring-shaped (return electrode coil 86; Figure 5) and has an outer diameter of 0.2mm to 0.5mm ([0079]; outer diameter of 0.0095 inches is 0.24 mm, which is within the claimed range).
Regarding claim 6, Ford as modified teaches the claimed invention, as discussed above, except for material of the second cathode 86 is a stainless steel wire or a platinum alloy. However, in [0079], Ford teaches that second cathode 86 is made of a suitably electrically conductive material, which one of ordinary skill in the art would recognize includes steel ([0076], [0110]). It would have been obvious to one of ordinary skill to modify the second cathode to be stainless steel since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Regarding claim 7, Ford as modified teaches the support spring 92 is made by winding a wire with a diameter of 0.03mm to 0.08mm ([0084]; wire diameter is 0.002 inches, which is 0.05 mm and within the claimed range), and the support spring has an outer diameter of 0.2mm to 0.6mm (Id.; outer diameter of 0.009 inches, which is 0.23 mm and within the claimed range). Although the support spring is not made of stainless steel, but rather is a marker coil made of platinum (Id.), in another embodiment shown in Figure 7, instead of marker coil, there can be a support spring in the form of steel flex coil 295 ([0106]) while the marker coil 292 can be placed within the steel flex coil.
It is also noted that the claimed phrase “made by winding a wire” is being treated as a product by process limitation; that is the product covered by the claim is not expressly limited by the process steps set forth in the claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Regarding claim 8, Ford as modified teaches a middle part of the support spring 295 (Figure 7) has a support core wire, and the support core wire is a stainless steel wire and has a diameter of 0.05mm to 0.36mm ([0106]; flex coil 295 has outer diameter of 0.0105 inches, which is 0.27 mm and within the claimed range). Although the stainless steel wire is not taught as being “taper-grinding” (as in ground, tapered, or reduced in diameter), one of ordinary skill in the art would find it obvious to reduce the middle portion diameter in order to facilitate connection with the marker coil 292 and the return coil 286 with an electrically conductive adhesive ([0106]).
Regarding claim 9, Ford as modified teaches the claimed invention, as discussed above, except for a distance between the second anode and the second cathode is 0.1mm. However, in [0010], Ford teaches that there is an effective distance between the anodic severable joint and cathodic return electrode, thereby decreasing the detachment time and increasing the reliability, repeatability, and uniformity of the detachment process. Therefore, one of ordinary skill in the art would acknowledge that the distance between the second anode and the second cathode is a result effective variable which could be optimized to decrease the detachment time of the implant at the separation point. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distance between the second anode and the second cathode to be 0.1mm since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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