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 § 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 21, 23-24, 26-27, 29-31, 35, 37, and 39-43 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi et al. (U.S. PGPub 2018/0264237) in view of Chen et al.
Claim 21: Palushi discloses a method of manufacturing a surgical guidewire (200), the surgical guidewire including: (i) an outer coil assembly (214/250 - paragraphs 80 and 84) having a proximal portion (left in Figs. 9 and 11) and a distal portion (right, Id.), (ii) a position sensor (270 - paragraph 86), (iii) an adhesive (used throughout - e.g. paragraphs 80, 82, 88-89), (iv) a core wire (240), and (v) a hollow tube (260), and an atraumatic tip (264 - paragraph 89), the method comprising: securing the atraumatic tip to a distal end of the tube (Id.; Fig. 13); securing the outer coil assembly (250) to the proximal end of the tube (paragraph 85; Fig. 13); soldering, brazing, or welding the core wire to an inner diameter of the tube (e.g. soldering other suitable technique - paragraph 90); and securing the position sensor within the tube (paragraph 88).
Palushi discloses that “any suitable…configuration(s) may be used to form hypotube” (paragraph 85), but does not disclose the hollow tube assembly as having both a proximal tube and a distal tube, and securing the distal tube to the proximal tube with the adhesive. However, Chen et al. teaches a guidewire wherein a distal tube may comprise either monolithic tube or an assembly between a proximal tube (e.g. 620a) and a distal tube (620b, Id.) “bonded together” (Fig. 8; paragraphs 77-80). It would have been obvious to one of ordinary skill in the at the time of invention to have formed the hollow tube of Palushi from an assembly between a proximal tube and a distal tube in order to have achieved certain benefits such as smooth transition in flexibility or improving the bond with the core wire and tip (Id.). Regarding the use of the adhesive to secure the distal tube to the proximal tube, Chen describes them as being “bonded together”, and uses adhesive for bonding purposes, which may be applied to any “bond” disclosed therein (e.g. paragraph 34). Palushi also uses adhesive throughout the guidewire assembly for bonding various components together as cited above. Thus it would have been obvious to have used adhesive for the bond between the tubes. Given the two-part tube construction, the atraumatic tip would be analogously secured to a distal end of the distal tube, the outer coil assembly would be secured to the proximal tube, the core wire would be secured to an inner diameter of at least one of the proximal tube or the distal tube, and the position sensor would be secured within at least one of the proximal tube or the distal tube.
Palushi and Chen do not necessarily teach after soldering, brazing, or welding the core wire, securing the position sensor within at least one of the proximal tube or the distal tube. However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation. In any case, the parts would have been assembled together as desired. Additionally or alternatively, it would have been obvious to have positioned the sensor after soldering, brazing, or welding the core wire since there would otherwise be very little space within the hypotube in which to fit the requisite soldering/brazing/welding tool (see e.g. paragraphs 91-92 and Fig. 13).
Claim 23: Referring to Palushi, the surgical guidewire comprises a communication wire (220), and the method further comprises providing communication of signals from the position sensor via the communication wire (paragraph 79).
Claim 24: Palushi further discloses routing the communication wire through the outer coil assembly to the position sensor (paragraphs 79, 84, and 86).
Claim 26: Palushi further discloses affixing the core wire to the proximal portion of the outer coil assembly (paragraph 82).
Claim 27: As modified, Palushi would further result in affixing the proximal tube to the distal portion of the outer coil assembly (paragraph 85; Fig. 13).
Claim 29: Palushi and Chen do not teach that the step of securing the atraumatic tip to the distal end of the distal tube is performed before the step of securing the distal tube to the proximal tube with the adhesive. However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation. In this case, whether the tip is secured to the tubes before or after the tubes are secured to each other, either order of steps would be expected to result in the same final assembly between the tubes and tip.
Claim 30: Palushi further discloses that the tip may be secured to the tube via adhesive or other suitable methods “apparent to those of ordinary skill in the art” (paragraph 89), but not necessarily laser welding. However, Chen teaches using laser welding for various welded portions of the guidewire (e.g. paragraphs 46, 60, 75), including as an alternative to other techniques such as adhesives. It thus would have been obvious to have used laser welding specifically since it is known in the art to be fast and precise, for example.
Claim 31: Palushi further discloses that the outer coil assembly comprises a bend (paragraph 31).
Claim 41: Securing the position sensor within at least one of the proximal tube or the distal tube comprises securing the position sensor relative to the core wire (at least indirectly by virtue of the hypotube).
Claim 42: Securing the position sensor within at least one of the proximal tube or the distal tube comprises avoiding damaging heat exposure to the position sensor (e.g. the sensor may “avoid” damaging heat exposure by virtue of being shielded by the tube(s)). Additionally or alternatively, Palushi is presumed not to damage the sensor as otherwise the disclosed method would be for making an inoperable product. The prior at is presumed to be operable (MPEP 2121 I.).
Claim 43: Securing the distal tube to the proximal tube with the adhesive comprises encapsulating the position sensor within the hollow tube assembly (the sensor is encapsulated within the tube - Fig. 13; paragraph 88).
Claim 35: Palushi discloses a method of manufacturing a surgical guidewire (200) comprising an outer coil assembly (214/250 - paragraphs 80 and 84) having a proximal portion (left in Figs. 9 and 11) and a distal portion (right, Id.), a position sensor (270 - paragraph 86), an adhesive (used throughout - e.g. paragraphs 80, 82, 88-89), a core wire (240), and a hollow tube (260), and an atraumatic tip (264 - paragraph 89), the method comprising: securing the atraumatic tip to a distal end of the tube (Id.; Fig. 13); soldering, brazing, or welding a distal end of the core wire to an inner diameter of the tube (e.g. soldering other suitable technique - paragraph 90); securing the proximal end of the hollow tube to the distal portion of the outer coil assembly (paragraph 85; Fig. 13), securing a proximal end of the core wire to the proximal portion of the outer coil assembly (paragraphs 81-82); and positioning the position sensor within the tube (Fig. 13; paragraph 88).
Palushi discloses that “any suitable…configuration(s) may be used to form hypotube” (paragraph 85), but does not disclose the hollow tube assembly as having both a proximal hollow tube and a distal hollow tube, and securing a proximal end of the distal hollow tube to the distal end of the proximal hollow tube. However, Chen et al. teaches a guidewire wherein a distal tube may comprise either monolithic tube or an assembly between a proximal tube (e.g. 620a) and a distal tube (620b, Id.) “bonded together” (Fig. 8; paragraphs 77-80). It would have been obvious to one of ordinary skill in the at the time of invention to have formed the hollow tube of Palushi from an assembly between a proximal tube and a distal tube in order to have achieved certain benefits such as smooth transition in flexibility or improving the bond with the core wire and tip (Id.). Given the two-part tube construction, the atraumatic tip would be analogously secured to a distal end of the distal tube, the core wire would be secured to an inner diameter of at least one of the proximal tube or the distal tube, the proximal hollow tube would be secured to the distal portion of the outer coil assembly; and the position sensor would be secured within at least one of the proximal hollow tube or the distal hollow tube.
Palushi and Chen do not necessarily teach after soldering, brazing, or welding the distal end of the core wire, positioning the position sensor within at least one of the proximal hollow tube or the distal hollow tube. However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation. In any case, the parts would have been assembled together as desired. Palushi is presumed not to damage the sensor as otherwise the disclosed method would be for making an inoperable product. The prior at is presumed to be operable (MPEP 2121 I.). Additionally or alternatively, it would have been obvious to have positioned the sensor after soldering, brazing, or welding the core wire since there would otherwise be very little space within the hypotube in which to fit the requisite soldering/brazing/welding tool (see e.g. paragraphs 91-92 and Fig. 13).
Claim 37: As modified, Palushi would further result in securing the position sensor to at least one of the proximal hollow tube or the distal hollow tube (paragraph 88).
Claim 39: Palushi discloses a method of manufacturing a surgical guidewire (200) comprising an outer coil (214/250 - paragraphs 80 and 84) extending from a proximal portion (left in Figs. 9 and 11) to a distal portion (right, Id.), a position sensor (270 - paragraph 86), a communication wire (220), a core wire (240), and a hollow tube (260), and an atraumatic tip (264 - paragraph 89), the method comprising: connecting the communication wire to the position sensor (paragraph 86; Fig. 13); securing a first end of the core wire to the proximal portion of the outer coil (paragraphs 81-82) and soldering, brazing, or welding (soldering) a second end of the core wire to an inner diameter of the proximal hollow tube (paragraph 90); installing the position sensor within the proximal hollow tube (paragraph 88; Fig. 13) for avoiding heat exposure to the position sensor (e.g. by virtue of shielding the sensor from external heat by the tube); affixing the atraumatic tip to a distal end of the tube (Id.; Fig. 13).
Palushi does not explicitly disclose soldering, brazing, or welding the first end of the core wire to the proximal end of the outer coil, but does so “via an adhesive, via an epoxy, or using any other suitable means or techniques as will be apparent to those of ordinary skill in the art in view of the teachings herein” (paragraph 82). The examiner submits that in view of paragraph 90, which uses solder to secure the other end of the core wire, one of ordinary skill would have recognize that soldering would be another suitable means or technique and thus would have been an obvious provision.
Palushi discloses that “any suitable…configuration(s) may be used to form hypotube” (paragraph 85), but does not disclose the hollow tube as having both a proximal hollow tube and a distal hollow tube, and affixing a proximal end of the distal hollow tube to the distal end of the proximal hollow tube. However, Chen et al. teaches a guidewire wherein a distal tube may comprise either monolithic tube or an assembly between a proximal tube (e.g. 620a) and a distal tube (620b, Id.) “bonded together” (Fig. 8; paragraphs 77-80). It would have been obvious to one of ordinary skill in the at the time of invention to have formed the hollow tube of Palushi from an assembly between a proximal tube and a distal tube in order to have achieved certain benefits such as smooth transition in flexibility or improving the bond with the core wire and tip (Id.). Given the two-part tube construction, the atraumatic tip would be analogously secured to a distal end of the distal hollow tube, the core wire would be soldered/brazed/welded to an inner diameter of the proximal tube (paragraph 90 and Fig. 13, solder joint 242 at proximal half of the tube), and the position sensor would be secured within at the proximal hollow tube (it occupies essentially the entire length of the tube).
Palushi and Chen do not necessarily teach after the soldering, brazing, or welding the core wire to the proximal hollow tube, installing the position sensor. However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation. In any case, the parts would have been assembled together as desired. Palushi is presumed not to damage the sensor as otherwise the disclosed method would be for making an inoperable product. The prior at is presumed to be operable (MPEP 2121 I.). Additionally or alternatively, it would have been obvious to have positioned the sensor after soldering, brazing, or welding the core wire since there would otherwise be very little space within the hypotube in which to fit the requisite soldering/brazing/welding tool (see e.g. paragraphs 91-92 and Fig. 13).
Claim 40: Palushi and Chen do not necessarily teach the step of affixing the atraumatic tip to the distal hollow tube being performed before the step of affixing the proximal end of the distal hollow tube to the distal end of the proximal hollow tube. However, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation. In this case, whether the tip is secured to the tubes before or after the tubes are secured to each other, either order of steps would be expected to result in the same final assembly between the tubes and tip.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Palushi et al. and Chen et al. as applied to claim 21 above, and further in view of Sela et al. (U.S. PGPub 2011/0152721).
Palushi and Chen teach a method substantially as claimed except for the adhesive including instant glue. However, Sela teaches the use of instant glue (e.g. cyanoacrylate - paragraph 76, noting that “instant glue” is interpreted by the examiner as referring to cyanoacrylate adhesive, or so-called “super glue”, or similar adhesives) for use in bonding various guidewire components together, including adjacent tube segments (764 and 762 - paragraph 78). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used instant glue since it is generally understood to bond quickly and strongly. Furthermore, 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 as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation.
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Palushi et al. and Chen et al. as applied to claim 21 above, and further in view of Gill et al. (U.S. PGPub 2020/0222067, cited in IDS).
Claim 33: Palushi and Chen teach a method substantially as claimed except for wherein the atraumatic tip comprises a distal tip portion and a proximal tip portion, the proximal tip portion having an outside diameter, the method further comprising inserting the outside diameter of the proximal tip portion into an inside diameter of the distal tube. However, Gill teaches several alternative geometries of tips for a guidewire, some including a proximal tip portion (e.g. stem 66 in Figs. 10A-E) having an outside diameter configured for being inserted into an inner diameter of a mating section (paragraph 78). It would have been an obvious matter for one of ordinary skill to have provided a similar tip for the purpose of providing a mechanical male/female joint, as is generally known in the art of forming joints between parts.
Claim 34: Palushi may use an adhesive to attach the tip to the tube (paragraph 89). Gill also mentions using adhesive to attach the tips (paragraph 86). In view of the above, the examiner submits that it would have been an obvious matter for one of ordinary skill to have applied glue to the external diameter of the proximal tip portion (i.e. an outer diameter surface of the extension 66) which is inserted into an inner diameter of the hollow tube, since it provides additional surface area for gluing in addition to the mechanical male/female joint, as is generally known in the art of forming joints between parts. Regarding applying the adhesive before the step of inserting the outside diameter of the proximal tip portion into the inside diameter of the distal tube, the examiner notes that adhesive is typically applied to a part before the part is adhered to a mating part, and so applying adhesive beforehand would have been obvious. Furthermore, it has been held that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Please note that in the instant application, Applicant has not disclosed any criticality for the claimed limitation. In any case, the parts would have been adhered together as desired.
Response to Arguments
Applicant's arguments filed 5/7/2026 have been fully considered.
The rejections based upon Meller have been withdrawn in view of the independent claims requiring soldering, brazing, or welding the core wire to the tube. Meller only attaches the core wire indirectly via encapsulant (meant to be electrically insulative) as opposed to a solder/weld/braze which would presumably be conductive.
The rejections based upon Palushi have been substantially maintained.
Applicant’s arguments otherwise continue to rely on the premise that the claimed order of steps is “critical” to the claimed invention. Applicant asserts that “[t]he amendments to the abstract and specification serve to underscore the criticality of the claimed step order in claims and are supported by the present application” (Remarks, page 7). However, while the amendments find literal support, for example in paragraph 83 or the specification as originally filed, they merely reiterate part of what was already disclosed and do not necessarily add anything to the conversation regarding the alleged criticality of the order of steps. The examiner notes that if new information could be gleaned from the entry of this amendment, then it may constitute new matter.
The examiner disagrees that the disclosed order of steps is “critical” as asserted by Applicant. Upon further consideration as necessitated by Applicant’s remarks, the disclosure does not necessarily provide a direct nexus between the specific order of steps, for example as discussed in [00083] and Fig. 18. [00083] recites an “exemplary set of steps”, and [00084] then states “In the present example, position sensor (430) is assembled into guidewire ( 400) in an isolated enclosure (i.e., hypotube assembly (470)) [after the steps of securing the core wire to the proximal hollow tube via soldering, brazing, or welding] without introducing any heat that could otherwise damage position sensor (430).” The disclosure does not necessarily state that the lack of damaging heat is by virtue of the specific order listed. The amendment to the specification reiterates an aspect of the order recited in [00083] but does not cure the above deficiency. The terms “heat”, “damage”, or the like are not discussed in this context elsewhere. One could see how the order of steps may result in such a benefit, but the “criticality” is not clear. Other factors besides step order may also play into whether the sensor is damaged, such as time of exposure, proximity to the heat source, and the robustness of the sensor.
Applicant also argues that the avoidance of damaging heat exposure is a new or unexpected result (Remarks, page 11). However, as noted in the previous Office Action, to properly assert unexpected results requires evidence, and such evidence is lacking in the record. Applicant also admits that one of ordinary skill understands that the claimed securing techniques are indeed hot, and that such heat would damage a position sensor. The examiner thus questions whether avoiding heat damage to a sensor by avoiding positioning of said sensor near a heat source (e.g. soldering, welding, brazing) is really unexpected or surprising. One of ordinary skill would not be particularly motivated to expose a sensor known to be sensitive to heat to such known sources of heat. It could then even be argued that performing the steps of the prior art in such a way as to minimize heat expose is common sense.
Applicant’s remaining arguments rely on those addressed above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P TRAVERS whose telephone number is (571)272-3218. The examiner can normally be reached 10:00AM-6:30PM.
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/Matthew P Travers/Primary Examiner, Art Unit 3726
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