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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 39, 42, and 44-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 39 recites “after permitting cooling of the proximal hollow tube from the soldering, brazing, or welding, installing the position sensor…”. Claims 44 and 45 similarly recite “before the installing the position sensor within the proximal hollow tube, the method comprises permitting the proximal hollow tube and the distal hollow tube to cool”. The specification does not describe any step involve permitting cooling prior to any subsequent step.
Claim 39 recites “installing the position sensor within the proximal hollow tube for avoiding heat exposure to the position sensor”. Claim 42 similarly recites “wherein securing the position sensor within at least one of the proximal tube or the distal tube comprises avoiding heat exposure to the position sensor”. The disclosure mentions assembling the position sensor into the guidewire “without introducing any heat that could otherwise damage position sensor”. It does not support avoiding heat entirely as claimed. For example, after the sensor is positioned within the hypotube, the parts of the hypotube are subsequently joined via techniques such as welding, brazing, or soldering, which apply heat to the hypotube with the sensor inside (paragraph 83). Only heat to a level which would actually damage the sensor is implicitly avoided.
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, 27, 29-31, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Meller et al. (U.S. PGPub 2012/0172761, cited in IDS) in view of Chen et al. (U.S. PGPub 2008/0064989).
Claim 21: Meller et al. discloses a method of manufacturing a surgical guidewire (36), the surgical guidewire including: (i) an outer coil assembly (52) having a proximal portion (toward 40) and a distal portion (toward proximal end of tube 48), (ii) a position sensor (44, e.g. title and paragraphs 39-40), (iii) an adhesive (adhesives used in various locations - e.g. paragraph 33, 36) (iv) a core wire (42), and (v) a hollow tube assembly having: a tube (48) and an atraumatic tip (50 - paragraph 33), the method comprising: securing the atraumatic tip to a distal end of the hollow tube (paragraph 33); securing the outer coil assembly to a proximal end of the tube (paragraph 36); securing the distal end of the core wire to an inner diameter of the tube (generally to the hollow tube, at least indirectly via the tip 50, see paragraph 33 - noting the securement would be at least indirect via encapsulant, see paragraph 42); and securing the position sensor within the tube (Id.).
Meller 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 Meller 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). Meller 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 outer coil would also be secured specifically to the proximal tube, and the core wire and the position sensor would be secured to/within at least one of the proximal and distal tubes.
Meller and Chen do not necessarily teach after securing 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.
Claim 23: Referring to Meller, the surgical guidewire comprises a communication wire (54), and the method further comprises providing communication of signals from the position sensor via the communication wire (paragraph 45).
Claim 24: Meller routs the communication wire through the outer coil assembly to the position sensor (e.g. paragraph 33; Fig. 3).
Claim 27: Meller further discloses affixing the proximal end of the hollow tube (and thus the proximal tube as modified by Chen) to the distal end of the outer coil assembly (paragraph 36).
Claim 29: Meller 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: Meller further discloses securing the atraumatic tip to the distal tube (distal end of the tube 48) with welding (paragraph 33). The welding is not laser welding. However, Chen teaches using laser welding for certain welded portions of the guidewire (e.g. paragraphs 46, 60, 75). It 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: The outer coil assembly includes a bend broadly in the sense that a coil is in essence one continuous helical bend. Alternatively, the device is expected to be bent during its use (e.g. Meller, paragraph 8, 36), and so it would have been obvious to have provided a bend in the device at least during its use.
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 (Meller, paragraph 42).
Claim 42: Securing the position sensor within at least one of the proximal tube or the distal tube comprises avoiding heat exposure to the position sensor (e.g. the sensor may “avoid” exposure to heat by virtue of being shielded by the tube(s)). Additionally or alternatively, Meller does not necessarily require any assembly steps requiring heat, as all steps mentioning soldering or welding alternatively offer adhesive as an option.
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 - paragraph 42).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Meller 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).
Meller 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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Meller et al. and Chen et al. as applied to claim 21 above, and further in view of Jenkins et al. (U.S. PGPub 2016/0310041, cited in IDS).
Claim 26: Meller does not disclose affixing the core wire to the proximal portion of the outer coil assembly. However, Jenkins teaches affixing a core wire to the proximal end of an outer coil of a guidewire (e.g. paragraph 83). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fixed the proximal end of core wire to the proximal end of the outer coil since it provides additional structural integrity to the outer coil and may prevent or restrict longitudinal stretching of outer coil (Id.).
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Meller 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: Meller 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: Meller may use an adhesive to attach the tip to the tube (paragraph 33). 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.
Claim 31 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Meller et al. and Chen et al. as applied to claim 21 above, and further in view of Sema et al. (U.S. PGPub 2018/0214216).
Alternatively to the bend scenarios discussed above, Sema discloses forming a preformed bend (256) in the coil of a guidewire (paragraph 71). It would have been obvious to one of ordinary skill in the art to have included such a bend in the coil of Meller depending upon the surgical procedure to be performed using the guidewire.
Claims 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Meller et al. in view of Chen et al. and Jenkins et al.
Claim 35: Meller et al. discloses a method of manufacturing a surgical guidewire (36) comprising an outer coil assembly (52) having a proximal portion (toward 40) and a distal portion (toward proximal end of tube 48), a position sensor (44, e.g. title and paragraphs 39-40), an adhesive (adhesives used in various locations - e.g. paragraph 33, 36), a core wire (42), and a hollow tube assembly having: a tube (48) and an atraumatic tip (50 - paragraph 33), the method comprising: securing the atraumatic tip to a distal end of the hollow tube (paragraph 33); securing the proximal end of the hollow tube to the distal portion of the outer coil assembly (paragraph 36); and securing the position sensor within the tube (paragraph 33).
Meller 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. 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 Meller from an assembly between a proximal tube secured to 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.). Meller, as modified by Chen would thus further teach: securing the atraumatic tip specifically to the distal hollow tube; securing the distal end of the core wire to an inner diameter of at least one of the proximal hollow tube or the distal hollow tube (generally to the hollow tube, at least indirectly via the tip 50, see paragraph 33 - noting the securement would be at least indirect via encapsulant, see paragraph 42); securing the proximal hollow tube to the distal portion of the outer coil assembly; positioning the position sensor within at least one of the proximal tube or the distal tube (i.e., the sensor 44 is within the tube 48); and securing (bonding, see Chen as cited above) the proximal end of the distal hollow tube to the distal end of the proximal hollow tube.
Meller and Chen do not necessarily teach after securing 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.
Meller and Chen do not teach securing a proximal end of the core wire to the proximal portion of the outer coil assembly. However, Jenkins teaches affixing a proximal end of a core wire to the proximal end of an outer coil of a guidewire (e.g. paragraph 83). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fixed the proximal end of core wire to the proximal end of the outer coil since it provides additional structural integrity to the outer coil and may prevent or restrict longitudinal stretching of outer coil (Id.).
Claim 37: Meller (as modified by Chen) secures the position sensor to at least one of the proximal tube or the distal tube (e.g. paragraphs 33-34).
Claims 21, 23-24, 26-27, 29-31, 35, 37, and 39-45 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); securing the core wire to an inner diameter of the tube (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 securing 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.
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 reducing heat exposure to the position sensor (e.g. the sensor may “avoid” exposure to heat by virtue of being shielded by the tube(s)). Additionally or alternatively, Palushi does not necessarily require any assembly steps requiring heat, as the assembly steps of the hypotube and related components mentioning soldering or welding alternatively offer adhesive as an option.
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 44: The securing the core wire comprises applying heat (e.g. solder - paragraph 90). Palushi does not explicitly disclose before the installing the position sensor within the proximal hollow tube, permitting the proximal hollow tube and the distal hollow tube to cool. However, assuming the order of steps as taught above, then the examiner submits that any amount of time between securing the core wire and securing the position sensor would inherently lead to some degree of cooling (loss of residual heat to the environment) once the heat of soldering is no longer applied.
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); securing a distal end of the core wire to an inner diameter of the tube (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 securing 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.
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 45: The securing the core wire comprises applying heat (e.g. solder - paragraph 90). Palushi does not explicitly disclose before the installing the position sensor within the proximal hollow tube, permitting the proximal hollow tube and the distal hollow tube to cool. However, assuming the order of steps as taught above, then the examiner submits that any amount of time between securing the core wire and securing the position sensor would inherently lead to some degree of cooling (loss of residual heat to the environment) once the heat of soldering is no longer applied.
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, 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. Following from this, Palushi does not explicitly disclose permitting cooling of the proximal hollow tube from the soldering, brazing, or welding before the installing the position sensor. However, assuming the order of steps as taught above, then the examiner submits that any amount of time between securing the core wire and securing the position sensor would inherently lead to some degree of cooling (loss of residual heat to the environment) once the heat of soldering is no longer applied.
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 10/27/2025 have been fully considered.
Applicant’s arguments partially rely on amendments to the claims, where the amended claims have been addressed in the rejection above.
Applicant’s arguments otherwise rely on the premise that the claimed order of steps is “critical” to the claimed invention. For example, “Applicant believes that the criticality…of the order of the steps is apparent to a person of skill in the art” (Remarks, page 8); “this order is critical for preserving the integrity of the position sensor” (top of page 9). See also:
(Page 9) Thus, the assembly order is critical because it isolates the position sensor from exposure to elevated temperatures generated during the attachment of the core wire…This sequence is detailed in [0076], where the method comprises: "As a first step, the atraumatic tip (410) is secured (e.g., welded, brazed, soldered, adhered, etc.) to the distal end (476) of the distal hypotube (473) (block 500). The core wire (460) is secured (e.g., welded, brazed, soldered, adhered, etc.) to the proximal hypotube (471) (block 510). After the core wire (460) is secured to the proximal hypotube (471), the proximal hypotube (471) is secured (e.g., welded, brazed, soldered, adhered, etc.) to the distal portion ( 424) of the core wire assembly (420) (block 520). The position sensor (430) is inserted and secured (e.g., glued, etc.) within the proximal hypotube (471) (block 530). Next, the proximal end (474) of the distal hypotube (473) is secured (e.g., welded, brazed, soldered, adhered, etc.) to the distal end (454) of the proximal hypotube (471) (block 540).
(Page 10) Without this specific order, the guidewire's navigation capabilities-critical for precise ENT procedures like sinuplasty-would be unreliable, potentially resulting in surgical errors. Thus, the order is not arbitrary but indispensable for producing a functional, safe device.
The examiner finds Applicants arguments regarding criticality unconvincing. MPEP 2172.01 states that broad language in the disclosure (including the abstract) omitting an allegedly critical feature tends to rebut the argument of criticality. The abstract, for example, makes no mention of the order of steps. The instant disclosure even states that “none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors” (paragraph 86), where argument by counsel is presumably not necessarily by “the inventors or by a successor in interest to the inventors”. The disclosure generally makes no explicit mention of the criticality, necessity, or essential nature of these features. Per MPEP 2164.08(c) and 2172.01, the instant claims may be subject to rejection under various subsections of 35 U.S.C. 112 for failing to recite the specific sequence of steps outlined above and described as “critical” by Applicant. The claims as currently written include incomplete aspects thereof, and do not all require heating which is the premise of the alleged criticality. If the features in question are indeed critical, then they must be claimed in their entirety in every independent claim. Their absence from the claims contradicts Applicant’s assertions of criticality. The examiner had, in previous Office Actions/interviews, suggested that the alleged benefits of the order of steps are only realized for the full sequence steps per the disclosure (e.g. paragraphs 83-84), but the benefits are also only relevant if a heating method is used for the securement, which is not necessarily the case for independent claims 21 and 35. Paragraphs 83-84 don’t even necessarily attribute the avoidance of damaging heat to the order of steps, but only mention that the exemplary method as a whole does not introduce a level of heat sufficient to damage the sensor.
Applicant references [0004] of the instant application, which mentions nothing about heating or avoiding exposure to heat, and contrary to Applicant’s assertions, suggests nothing about traditional methods that “involve heat ( e.g., ovens) or imprecise adhesives that risk sensor damage or detachment, underscoring the criticality of the claimed sequence to avoid these issues”.
Applicant also alleges that the order of steps produce “unexpected results” (top of page 9; pages 10-11). However, per MPEP 716.01(c) I-II, allegations of unexpected results require evidence, such as in the form of an affidavit. None has been presented herein. Applicant also acknowledges (see page 9) that one of ordinary skill would recognize that techniques such as soldering, welding, and brazing produce high heat, and that such heat could damage the types of sensors used in the present application. Can it really be considered "unexpected results" that performing the heat-producing steps prior to introduction of the sensor as opposed to after (where there would be limited options for assembly order in actual practice) would reduce heat exposure to the sensor? Even if the prior art, which does perform heat-producing assembly steps at certain points, were to perform the assembly in a different order from that claimed, they presumably do so without destroying the sensor, and so can the order really be said to be "critical", i.e. absolutely necessary, to the invention? Exposure to heat would depend on other factors, such as time of exposure and proximity of the sensor to the heat sources.
Applicant’s remaining arguments rely on those addressed above.
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