DETAILED ACTION
The following is a Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 6/16/2026.
Applicant’s amendments are sufficient to overcome the specification objection set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action except for Par. 12 to claim 14.
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 14 is 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 recites the limitation "where the conductive material portion has a viscosity less than or equal to about 10,000 centipoise". It is unclear how the conductive material can have a viscosity on the device since this would indicate that during use, the material could flow off the device. The Examiner notes that the limitation for the conductive material portion to have a viscosity less than or equal to about 10,000 centipoise will be treated as a product-by-process limitation, where the material has the claimed viscosity during manufacturing.
Claim Interpretation
Claim 14 recites the limitation "wherein the conductive material portion has a longitudinal resistance of less than or equal to about twenty Ohms". The Examiner notes that this limitation will be interpreted as being the resistance of the conductive material portion along the length of the conductive material portion.
Claim Rejections - 35 USC § 102/103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 8-9, 11, 13, 19 & 21 is/are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by Rydell (5,035,696, previously cited), or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134).
Concerning claim 1, as illustrated in at least Figs. 1, 3, 5 & 8, Rydell discloses a bipolar sphincterotome to perform a sphincterotomy at a treatment site (sphincterotome 10; Col. 3, ll. 37-43), the bipolar sphincterotome comprising:
an elongate tubular member (plastic tube 12; Col. 3, ll. 37-64);
a cutting wire disposed within the elongate tubular member and extends to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member (cutting wire 26 has a cutting edge outside plastic tube 12 and emerges from small lateral aperture 28; Col. 3, ll. 37-64, Col. 4, ll. 46-63);
a return path comprising:
a return wire disposed within the elongate tubular member (conductor 24 connects to a contact passing through the wall of the slot 56 and a conductor 80 joins thereto and leads to the other output terminal of the electrosurgical generator; Col. 4, ll. 46-63); and
a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (conductive silicone layer 88 // or // conductive polymer 92 connects to electrical conductor 24 that runs through lumen 82 along the length of plastic tube 12 and can be a bare wire or coated with an insulating layer to prevent short circuiting if running in a single lumen with electrical conductive/wire 26; Col. 3, ll. 37-64, Col. 4, ll. 46-63, Col. 5, ll. 10-37),
wherein the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening (conductive silicone layer 88 // or // conductive polymer 92 extends alongside cutting wire 26 and proximally past aperture 28; Col. 3, ll. 37-64, where “proximally” can be defined as “toward or near a proximal part or point” and “past” can be defined as “so as to reach and go beyond a point near at hand” (www.merriam-webster.com) and thus, under BRI, the conductive silicone layer 88 // or // conductive polymer 92 “extends” toward or near a proximal part or point so as to reach and go beyond a point near “the opening”. In the alternative, Rydell teaches conductive material portions to have various surface areas and locations (e.g., Fig. 6: circumferential surface area extending between opening 28 and anchor 30; Fig. 7: partial circumferential surface area extending between opening 28 to the distal most end; Fig. 8: partial circumferential surface area located only between opening 28 and anchor 30 (Fig. 6-10) and thus contemplates differing sizes and locations for the return electrode. Woloszko et al. teach a bipolar device where the surface area of the return electrode is greater than that of the active electrode and that the greater the return electrode to active electrode surface area ratio, the greater the current density at the active electrode, wherein the surface area ratio is affected by the relative lengths and/or perimeter dimensions of the return and active electrode ([0029]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Rydell such that the conductive material portion longitudinally extends from a point that is located more proximally than the opening along a longitudinal axis of the device as a matter of design choice in order to provide the benefit of a desired current density at active cutting electrode wire as taught by Woloszko et al.).
Concerning claim 2, Rydell discloses the conductive material portion (88 // or // 92) comprises a circumferential disposition that provides visual access to a wire guide lumen (lumen connecting to distal ejection port 32) longitudinally extending within the elongate tubular member (12) (Fig. 1 & 8).
Concerning claim 8, Rydell discloses a lumen (18) disposed and longitudinally extending within the elongate tubular member (12), wherein the lumen (18) has two or more functions (Col 3, ll. 37-64 & Col. 5, ll. 10-19 & 32-37; Fig. 7).
Concerning claim 9, Rydell discloses the lumen (18) comprises an injection lumen (18), wherein another of the two or more functions is to deliver contrast to a treatment site (Col 3, ll. 37-64; Fig. 1 & 7).
Concerning claim 11, Rydell discloses a lumen (82) disposed and longitudinally extending with the elongate tubular member (12), wherein the lumen (82) has a single function, the single function being to house the return wire (82) (Col. 5, ll. 32-37; Fig. 5).
Concerning claim 13, Rydell discloses the conductive material portion (88 // or // 92) distally extends past an anchor point (30) where a distal end of the cutting wire (26) is fixedly attached to the elongate tubular member (12) (Col. 3, ll. 37-64; Fig. 7-8)
Concerning claim 19, as illustrated in at least Figs. 1, 3, 5 & 7, Rydell discloses a bipolar sphincterotome to perform a sphincterotomy at a treatment site within a patient (sphincterotome 10; Col. 3, ll. 37-43), the bipolar sphincterotome comprising:
an elongate tubular member (plastic tube 12; Col. 3, ll. 37-64);
a cutting wire disposed within the elongate tubular member, except for a cutting edge of the cutting wire, wherein the cutting edge protrudes from the elongate tubular member via an opening (cutting wire 26 has a cutting edge outside plastic tube 12 and emerges from small lateral aperture 28; Col. 3, ll. 37-64, Col. 4, ll. 46-63);
a return path comprising:
a return wire disposed within the elongate tubular member (conductor 24 connects to a contact passing through the wall of the slot 56 and a conductor 80 joins thereto and leads to the other output terminal of the electrosurgical generator; Col. 4, ll. 46-63); and
a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (conductive silicone layer 88 // or // conductive polymer 92 connects to electrical conductor 24 that runs through lumen 82 along the length of plastic tube 12 and can be a bare wire or coated with an insulating layer to prevent short circuiting if running in a single lumen with electrical conductive/wire 26; Col. 3, ll. 37-64, Col. 4, ll. 46-63, Col. 5, ll. 10-37),
wherein proximal end of the conductive material portion is disposed proximal the opening (conductive silicone layer 88 // or // conductive polymer is disposed proximal aperture 28; Col. 3, ll. 37-64, where “proximal” can be defined as “situated close to” (www.merriam-webster.com), and thus, under BRI, the conductive silicone layer 88 // or // conductive polymer is disposed situated close to aperture 28. In the alternative, Rydell teaches conductive material portions of different sizes (circumferential surface area, length) (Fig. 6-10). In the alternative, Rydell teaches conductive material portions to have various surface areas and locations (e.g., Fig. 6: circumferential surface area extending between opening 28 and anchor 30; Fig. 7: partial circumferential surface area extending between opening 28 to the distal most end; Fig. 8: partial circumferential surface area located only between opening 28 and anchor 30 (Fig. 6-10) and thus contemplates differing sizes and locations for the return electrode. Woloszko et al. teach a bipolar device where the surface area of the return electrode is greater than that of the active electrode and that the greater the return electrode to active electrode surface area ratio, the greater the current density at the active electrode, wherein the surface area ratio is affected by the relative lengths and/or perimeter dimensions of the return and active electrode ([0029]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Rydell such that the conductive material is disposed proximally of the opening along a longitudinal axis of the device as a matter of design choice in order to provide the benefit of a desired current density at active cutting electrode wire as taught by Woloszko et al.).
Rydell fails to disclose the opposite side to that picture in Fig. 7, and thus fails to disclose the circumferential disposition in which, within a cross-section perpendicular to a longitudinal axis of the elongate tubular member, no portion of the conductive material portion overlaps a geometric line that extends in the cross-section and that intersects circumferential ends of the conductive material portion and a geometric center of the elongate tubular member. However, in the embodiment of Fig. 8, Rydell discloses the conductive material portion (92) to be formed by filling a lumen with a conductive polymer at its distal end and then grinding away sidewall (82) of elongate member (12), thus leading to a symmetrical disposition of the conductive material portion (92) on the elongate tubular member. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the embodiment of Fig. 7 such that the circumferential disposition of the conductive material portion has a circumferential disposition that extends equally around the elongate tubular member as taught by the embodiment of Fig. 8, and thus also comprising a circumferential disposition that covers half the circumference of the elongate tubular member in which, within a cross-section perpendicular to a longitudinal axis of the elongate tubular member, no portion of the conductive material portion overlaps a geometric line that extends in the cross-section and that intersects circumferential ends of the conductive material portion and a geometric center of the elongate tubular member, in order to provide the benefit of an appropriately sized return electrode that allows for better control over depth of tissue destruction since the current path is concentrated in the area of surgery as taught by Rydell. (Col. 2, ll. 56-63, Col. 5, ll. 26-31; Fig. 5 & 7-8) and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Concerning claim 21, Rydell discloses an anchor point (30) disposed distal the opening (28), wherein the cutting wire (26) is fixedly attached to the elongate tubular member (12) via the anchor point (30) (Col. 3, ll. 37-64; Fig. 1, 3, 5 & 8).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3-4 & 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134), as applied to claims 1 & 19, in further view of Winkler (5,417,208, previously cited).
Concerning claims 3-4 & 20¸Rydell or Rydell/Woloszko et al. fail to disclose a conductive cannula disposed about the outer surface of the elongate tubular member, the conductive cannula electrically coupling the conductive material portion to the return wire, wherein at least a portion of the conductive material portion is further disposed over at least a portion of the conductive cannula to electrically couple the conductive material portion to the return wire. However, Winkler discloses an elongate tubular member (20) comprising a conductive cannula (51) disposed about an outer surface of the elongate tubular member (20), the conductive cannula (51) electrically coupling a conductive portion (30) to a conductive wire (45), wherein at least a portion of the conductive portion (30) is further disposed over at least a portion of the conductive cannula (51) to electrically couple the conductive portion (30) to the conductive wire (45). At the time of the invention, it would have been obvious to one ordinary skill in the art to modify the invention of Rydell or Rydell/Woloszko et al. to further comprise a conductive cannula disposed about the outer surface of the elongate tubular member, the conductive cannula electrically coupling the conductive material portion to the return wire, wherein at least a portion of the conductive material portion is further disposed over at least a portion of the conductive cannula to electrically couple the conductive material portion to the return wire in order to provide the benefit of a reliable adhesive free electrical contact to the conductive wire as taught by Winkler (Col. 2, ll. 30-36, Col. 6, ll. 51-22; Fig. 1 & 4-5).
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134), as applied to claim 4, in further view of Tegg et al. (2008/0161761, previously cited).
Concerning claim 5, Rydell, or Rydell in view of Woloszko, and in view of Winkler fail to disclose a shrink tube disposed over the conductive cannula. However, Tegg et al. disclose using shrink wrap coatings as desired over electrical connections. At the time of the invention, it would have been obvious to one ordinary skill in the art to modify the invention of Rydell, or Rydell in view of Woloszko, and in view of Winkler to further comprise a shrink tube disposed over the conductive cannula in order to provide the benefit of a conventional electrical connection coating as taught by Tegg et al. ([0062]).
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134), as applied to claim 1, in further view of Swanson et al. (5,991,650, previously cited).
Concerning claim 7, Rydell, or Rydell in view of Woloszko et al., fail to disclose a skive in the elongate tubular member extending from the outer surface to a location within the elongate tubular member that is in communication with a distal end of the return wire, wherein the conductive material portion extends within the skive to be electrically coupled to the return wire. However, Swanson et al. disclose a medical device (12) comprising a skive (80) in an elongate tubular member (26) extending from an outer surface to a location within the elongate tubular member (26) that is in communication with a distal end of a return wire (38), wherein a conductive material portion (24) extends within the skive (80) to be electrically coupled to the return wire (38). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Rydell, or Rydell in view of Woloszko, to further comprise a skive in the elongate tubular member extending from the outer surface to a location within the elongate tubular member that is in communication with a distal end of the return wire, wherein the conductive material portion extends within the skive to be electrically coupled to the return wire in order to provide the benefit of a bonded connection between the conductive material portions and lead wires as taught by Swanson et al. (Col. 5, II. 7-13, Col. 6-7, II. 52-30; Fig. 1 & 7-8)
Claim 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134), as applied to claim 1, in further view of McGaffigan (2004/0015162, previously cited).
Concerning claim 12, Rydell, or Rydell in view of Woloszko et al., fail to disclose the elongate tubular member is made of a substantially clear material. However, McGaffigan discloses a treatment device comprising an elongate tubular member (41/46) made of a substantially clear material. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Rydell, or Rydell in view of Woloszko et al., such that the elongate tubular member is made of a substantially clear material in order to provide the benefit of viewing the tip with an eyepiece on the device as taught by McGaffigan. ([0022], [0029]; Fig. 1)
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134), as applied to claim 1, in further view of Salahieh et al. (2012/0071870).
Concerning claim 14, Rydell, or Rydell in view of Woloszko et al., fail to disclose the specifics of the thickness, particles, viscosity, or longitudinal resistance of the conductive material. However, Salahieh et al. discloses a treatment device comprising a conductive material portion of conductive ink having a thickness of less than about 500 micrometers ([0144]). It would have been obvious to one having ordinary skill in the art at the time the invention was made for the thickness of the conductive material portion is less than or equal to about 500 micrometers as taught by Salahieh et al. since Applicant appears to have placed no criticality on the claimed range (Par. [0028] indicating the thickness “may have a thickness in a range of about 20-40 micrometers (microns), although other thicknesses may be used, including up to 500 microns”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It would have been obvious to one having ordinary skill in the art at the time the invention was made for the conductive material portion to comprise conductive ink particles having sizes in a range of about 3 to about 30 micrometers, where the conductive material portion has a viscosity less than or equal to about 10,000 centipoise, and wherein the conductive material portion to have a longitudinal resistance of less than or equal to about 20 Ohms, since Applicant appears to have placed no criticality on the claimed ranges (Par. [0028] indicated “Particles of the conductive ink may have a size in a range of about 3-30 microns. Also, the particles may be made of silver and/or may be suspended in a polyester binder. Additionally, the conductive ink may have a viscosity of about 250 centipoise (cP), although other viscosities may be used, including up to about 10,000 cP. Also, a resistance of the conductive ink portion 126 may be in a range of about zero (or substantially zero) to ten Ohms, when measured longitudinally.”) and 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 device of Rydell would not operate differently with the claimed ink particle size, conductive material portion viscosity, nor conductive ink longitudinal resistance.
Claim 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134), as applied to claim 1, in further view of Hebborn (5,480,399, previously cited).
Concerning claim 15, Rydell discloses cabling (80) that electrically couples the return path (24, 88 // 92) to a return port of a power source (Col. 4, ll. 46-63; Fig. 1). Rydell, or Rydell in view of Woloszko et al., fail to disclose the cabling comprises a first wire and a second wire, the first and second wires being shorted together at distal ends of the first and second wires, and wherein the first and second wires are connected to a proximal end of the return wire at the distal ends. However, Hebborn discloses a treatment device comprising a return path having a conductive material portion (21) and a return wire (22') and cabling (wires of P1, P2) that electrically couples the return path (21, 22') to a return port (60) of a power source, the cabling (wires of P1, P2), comprising a first wire (wire of P1) and a second wire (wire of P2), the first and second wires (wires of P1, P2) being shorted together at distal ends of the first and second wires, and wherein the first and second wires are connected to a proximal end of the return wire (21') at the distal ends. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Rydell, or Rydell in view of Woloszko et al., for the cabling to comprise a first wire and a second wire, the first and second wires being shorted together at distal ends of the first and second wires, and wherein the first and second wires are connected to a proximal end of the return wire at the distal ends in order to provide the benefit of determining if the return path is connected properly as taught by Hebborn (Col. 1, II. 47-59, Col. 2-3, II. 54- 4, Col. 4, II. 7-24; Fig. 1 & 3B).
Claims 16-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited) in view of Hebborn (5,480,399, previously cited), or in the alternative, Rydell (5,035,696, previously cited), or, in the alternative, Rydell (5,035,696, previously cited) in view of Woloszko et al. (2005/0251134) and Hebborn (5,480,399, previously cited), as applied to claim 15, in further view of Shilev (2010/0331835, previously cited) and Brannan (2011/0208184, previously cited).
Concerning claims 16-18, Rydell, or in the alternative, Rydell in view of Woloszko et al., in view of Hebborn fail to disclose a resistive element is included in one of the first wire or the second wire, wherein a resistance value of the resistive element configured to cause the power source to recognize the bipolar sphincterotome as using a split neutral electrode or a solid neutral electrode, nor a first resistive element is included in the first wire, and wherein a second resistive element is included in the second wire, wherein a sum of a resistance value of the first resistive element and a resistive value of the second resistive element configured to cause the power source to recognize the bipolar sphincterotome has a solid or split neutral electrode. However, Shilev discloses a medical system (10) comprising a return electrode detection and monitoring system that identifies whether a return or neutral electrode coupled to an electrosurgical generator is a split or non-split (solid) resistive electrode based on an electrode’s capacitance ([0026], [0045-0046]; Fig. 6). Further, Brannan discloses a medical system (1) comprising an identification system that utilizes an resistive element identifier to identify a probe type ([0034]; Fig. 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention Rydell, or in the alternative, Rydell in view of Woloszko et al., in view of Hebborn to comprise a resistive element included in at least one of the first wire or the second wire or a first and second resistive element is included in the first and second wires, respectively, wherein a resistance value of the resistive element, or a sum of the resistive values of the first and second resistance elements configured to cause the power source to recognize the bipolar sphincterotome as using a split neutral electrode or a solid neutral electrode in order to provide the benefit of combined universal recognition feature in a conventional ESU as taught by Shilev and to specifically identify the return electrode type connected to the generator as taught by Brannan.
Double Patenting
Claims 1-2, 7-9, & 11-19 of this application are patentably indistinct from claims 1-2, 7-9, & 11-19 of Application No. 18/497767. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-2, 7-9, & 11-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-2, 7-9, & 11-19 of copending Application No. 18/497767 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9,844,407. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a bipolar sphincterotome to perform a sphincterotomy at a treatment site (bipolar sphincterotome to perform a sphincterotomy at a treatment site), the bipolar sphincterotome comprising: an elongate tubular member (an elongate tubular member); a cutting wire disposed within the elongate tubular member and extends to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member (a cutting wire disposed within the elongate tubular member; a wire guide lumen disposed and longitudinally extending within the elongate tubular member, the cutting wire disposed outside of the wire guide lumen); a return path (a return path) comprising: a return wire disposed within the elongate tubular member (a return wire electrically coupled to the conductive material portion, the return wire disposed within the elongate tubular member and outside of the wire guide lumen); and a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (conductive material portion covering an outer surface at a distal portion of the elongate tubular member, the conductive material portion having a circumferential disposition about the outer surface that provides visual access to the wire guide lumen), wherein the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening (the conductive material portion distally extends past an anchor point where a distal end of the cutting wire is fixedly attached to the elongate tubular member).
Claims 1-9 & 11-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 & 13-20 of U.S. Patent No. 9,844,407 in view of Rydell et al. (5,035,696, previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a bipolar sphincterotome to perform a sphincterotomy at a treatment site (bipolar sphincterotome to perform a sphincterotomy at a treatment site), the bipolar sphincterotome comprising: an elongate tubular member (an elongate tubular member); a cutting wire disposed within the elongate tubular member and extends to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member (a cutting wire disposed within the elongate tubular member; a wire guide lumen disposed and longitudinally extending within the elongate tubular member, the cutting wire disposed outside of the wire guide lumen); a return path (a return path) comprising: a return wire disposed within the elongate tubular member (a return wire electrically coupled to the conductive material portion, the return wire disposed within the elongate tubular member and outside of the wire guide lumen); and a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (conductive material portion covering an outer surface at a distal portion of the elongate tubular member, the conductive material portion having a circumferential disposition about the outer surface that provides visual access to the wire guide lumen). The patent fails to disclose wherein the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening. However, Rydell discloses a bipolar sphincterotome having a conductive material portion (88 or 92) that longitudinally extends alongside at least a portion of the cutting edge and proximally past an opening (28) for a cutting wire (26) (conductive silicone layer 88 // or // conductive polymer 92 extends alongside cutting wire 26 and proximally past aperture 28; Col. 3, ll. 37-64, where “proximally” can be defined as “toward or near a proximal part or point” and “past” can be defined as “so as to reach and go beyond a point near at hand” (www.merriam-webster.com) and thus, under BRI, the conductive silicone layer 88 // or // conductive polymer 92 “extends” toward or near a proximal part or point so as to reach and go beyond a point near “the opening”. Rydell also teaches conductive material portions to have various surface areas and locations (e.g., Fig. 6: circumferential surface area extending between opening 28 and anchor 30; Fig. 7: partial circumferential surface area extending between opening 28 to the distal most end; Fig. 8: partial circumferential surface area located only between opening 28 and anchor 30 (Fig. 6-10) and thus contemplates differing sizes and locations for the return electrode. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening in order to provide the benefit of an appropriately sized return electrode such that resulting current path is localized to the tissue present between the active wire electrode and the return electrode as taught by Rydell (Col. 2, ll. 42-55) and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite bipolar sphincterotome to perform a sphincterotomy at a treatment site within a patient (bipolar sphincterotome to perform a sphincterotomy at a treatment site), the bipolar sphincterotome comprising: an elongate tubular member (an elongate tubular member); a cutting wire disposed within the elongate tubular member, except for a cutting edge of the cutting wire, wherein the cutting edge protrudes from the elongate tubular member via an opening (a cutting wire disposed within the elongate tubular member; a wire guide lumen disposed and longitudinally extending within the elongate tubular member, the cutting wire disposed outside of the wire guide lumen); a return path (a return path) comprising: a return wire disposed within the elongate tubular member (a return wire electrically coupled to the conductive material portion, the return wire disposed within the elongate tubular member and outside of the wire guide lumen); and a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (a conductive material portion covering an outer surface at a distal portion of the elongate tubular member, the conductive material portion having a circumferential disposition about the outer surface that provides visual access to the wire guide lumen). The patent fails to disclose wherein a proximal end of the conductive material portion is disposed proximal the open. However, Rydell discloses a bipolar sphincterotome having a conductive material portion (88 or 92) that longitudinally extends alongside at least a portion of the cutting edge and proximal, or situated closet to, to an opening (28) for a cutting wire (26). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such a proximal end of the conductive material portion is disposed proximal the open in order to provide the benefit of an appropriately sized return electrode such that resulting current path is localized to the tissue present between the active wire electrode and the return electrode as taught by Rydell (Col. 2, ll. 42-55) and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of co-pending application no. 18/497767. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite A bipolar sphincterotome to perform a sphincterotomy at a treatment site, the bipolar sphincterotome comprising: an elongate tubular member; a cutting wire disposed within the elongate tubular member and extending to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member; a return path comprising: a return wire disposed within the elongate tubular member; and a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member, wherein the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening, an anchor point disposed distal the opening, wherein the cutting wire is fixedly attached to the elongate tubular member via the anchor point.
Claims 1-9 & 11-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending application no. 18/385728 in view of Rydell (5,035,696). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a bipolar sphincterotome to perform a sphincterotomy at a treatment site (bipolar sphincterotome to perform a sphincterotomy at a treatment site), the bipolar sphincterotome comprising: an elongate tubular member (an elongate tubular member); a cutting wire disposed within the elongate tubular member and extends to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member (a cutting wire disposed within the elongate tubular member and extends to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member); a return path (a return path) comprising: a return wire disposed within the elongate tubular member (a return wire disposed within the elongate tubular member); and a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member, wherein the conductive material portion circumferentially extends less than halfway around the elongate tubular member). The co-pending application fails to disclose wherein the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening. However, Rydell discloses a bipolar sphincterotome having a conductive material portion (88 or 92) that longitudinally extends alongside at least a portion of the cutting edge and proximally past an opening (28) for a cutting wire (26) (conductive silicone layer 88 // or // conductive polymer 92 extends alongside cutting wire 26 and proximally past aperture 28; Col. 3, ll. 37-64, where “proximally” can be defined as “toward or near a proximal part or point” and “past” can be defined as “so as to reach and go beyond a point near at hand” (www.merriam-webster.com) and thus, under BRI, the conductive silicone layer 88 // or // conductive polymer 92 “extends” toward or near a proximal part or point so as to reach and go beyond a point near “the opening”. Rydell also teaches conductive material portions to have various surface areas and locations (e.g., Fig. 6: circumferential surface area extending between opening 28 and anchor 30; Fig. 7: partial circumferential surface area extending between opening 28 to the distal most end; Fig. 8: partial circumferential surface area located only between opening 28 and anchor 30 (Fig. 6-10) and thus contemplates differing sizes and locations for the return electrode. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the co-pending application such that the conductive material portion longitudinally extends alongside at least a portion of the cutting edge and proximally past the opening in order to provide the benefit of an appropriately sized return electrode such that resulting current path is localized to the tissue present between the active wire electrode and the return electrode as taught by Rydell (Col. 2, ll. 42-55) and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite bipolar sphincterotome to perform a sphincterotomy at a treatment site within a patient (bipolar sphincterotome to perform a sphincterotomy at a treatment site), the bipolar sphincterotome comprising: an elongate tubular member (an elongate tubular member); a cutting wire disposed within the elongate tubular member, except for a cutting edge of the cutting wire, wherein the cutting edge protrudes from the elongate tubular member via an opening (cutting wire disposed within the elongate tubular member and extends to outside of the elongate tubular member via an opening, wherein a cutting edge comprises a portion of the cutting wire that is outside of the elongate tubular member); a return path (a return path) comprising: a return wire disposed within the elongate tubular member (a return wire disposed within the elongate tubular member; and a conductive material portion electrically coupled to the return wire); and a conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member (conductive material portion electrically coupled to the return wire, the conductive material portion covering an outer surface at a distal portion of the elongate tubular member, wherein the conductive material portion circumferentially extends less than halfway around the elongate tubular member). The co-pending application fails to disclose wherein a proximal end of the conductive material portion is disposed proximal the open. However, Rydell discloses a bipolar sphincterotome having a conductive material portion (88 or 92) that longitudinally extends alongside at least a portion of the cutting edge and proximal, or situated closet to, to an opening (28) for a cutting wire (26). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such a proximal end of the conductive material portion is disposed proximal the open in order to provide the benefit of an appropriately sized return electrode such that resulting current path is localized to the tissue present between the active wire electrode and the return electrode as taught by Rydell (Col. 2, ll. 42-55) and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and an appropriate terminal disclaimer is submitted.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination teaches “a tube having an inner surface coated with a conductive material to electrically couple the conductive material portion with the conductive cannula” in combination with claim 3 claiming “a conductive cannula disposed about the outer surface of the elongate tubular member, the conductive cannula electrically coupling the conductive material portion to the return wire”.
Response to Arguments
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive; however, in order to move prosecution forward, the rejections of claims 1 & 19 above are now rejected under pre-AIA 35 USC 102(b) and, in the alternative, pre-AIA 35 USC 103(a).
In response to Applicant’s arguments that Rydell fails to disclose the “conductive segment (20/22/86/88/92) to longitudinally extend proximally past the aperture 28”, the Examiner respectfully disagrees. For reference, “proximally” can be defined as “toward or near a proximal part or point and “past” can be defined as “so as to reach and go beyond a point near at hand” (www.merriam-webster.com). Thus, under BRI, the claim recites that conductive material “extends” toward or near a proximal part or point beyond “the opening”. The claim fails to positively recite the conductive material longitudinally extending directly from a first position directly to a second position, where the opening is located distally with respect to the first position along a longitudinal axis of the device or the opening is located between the first and second positions along the longitudinal axis.
In response to Applicant’s arguments that Rydell fails to disclose “a proximal end” of conductive segment (20/22/86/88/92) “is disposed proximal the opening”, the Examiner respectfully disagrees. For reference, “proximal” can be defined as “situated close to” (www.merriam-webster.com). Thus, under BRI, the claim recites that the proximal end of conductive material is “situated close to” the opening 28. The claim fails to positively recite the conductive material longitudinally extending directly from a first position directly to a second position, where the opening is located distally with respect to the first position along a longitudinal axis of the device or the opening is located between the first and second positions along the longitudinal axis.
In response to Applicant’s arguments that the interpretation of “proximal” is in error, the Examiner respectfully disagrees as no specific definition of “proximal” (nor “distal”) with respect to a longitudinal axis of the device is stated in the originally filed disclosure.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights