DETAILED ACTION
The following is a 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 6/16/2016.
Applicant’s amendments to the specification are sufficient to overcome the specification objection set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action except for Par. 11 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.
Claim 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 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 of for the conductive ink 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 ink 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 material along the length of the ink.
Claim Rejections - 35 USC § 102
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, 11 & 13 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Rydell (5,035,696, previously cited).
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; 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 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 circumferentially extends less than halfway around the elongate tubular member (conductive polymer 92 is created by grinding away side wall of tube 12 to exposed conductive polymer 92 that fills one of the lumens of bilumen tube 12 which is less than halfway around tube 12; Col. 5, ll. 32-37).
PNG
media_image1.png
438
1096
media_image1.png
Greyscale
Concerning claim 2, Rydell discloses the conductive material portion (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 (82) disposed and longitudinally extending within the elongate tubular member (12), wherein the lumen (82) has two or more functions, one of the two or more functions being to house the return wire (24) (Col 3, ll. 37-64 & Col. 5, ll. 10-19 & 32-37; Fig. 5 & 8).
Concerning claim 11, Rydell discloses a lumen (82) disposed and longitudinally extending with the elongate tubular member, wherein the lumen 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 (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)
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 1-2, 8-9, 11, 13 & 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited).
Concerning claim 1, as illustrated in at least Figs. 1, 3, 5 & 7, 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; 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 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).
While Rydell discloses the conductive material portion (88) extends circumferentially less than the entire way around the elongate tubular member (12), Rydell fails to specifically disclose the conductive material portion circumferentially extends less than halfway around the elongate tubular member. However, in the alternative embodiment of Fig. 8, Rydell discloses a conductive material portion (92) that extends less than halfway around the elongate tubular member (12) (Col. 5, ll. 10-37).
PNG
media_image2.png
342
857
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of Rydell’ 696 Fig. 7 such that the conductive material portion circumferentially extends less than halfway around the elongate tubular member as taught by Rydell in Fig. 8 and is thus of whatever desired or expedient size since Applicant places no criticality on the size (Par. [0046]: “Figs. 2 and 3 show that the circumferential disposition of the conductive ink portion 126 extends about halfway around the tubular member (i.e., the dotted line 208, 308 extends through the center or origin of the tubular member 102)…[i]n alternative configurations, the circumferential disposition of the conductive ink portion 126 may extend less than halfway or more than halfway around the tubular member” 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 2, Rydell discloses the conductive material portion (88) 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 & 7).
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, one of the two or more functions being to house the return wire (24) (Col 3, ll. 37-64 & Col. 5, ll. 10-19 & 32-37; Fig. 5 & 8).
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 & 5).
Concerning claim 11, Rydell discloses a lumen (82) disposed and longitudinally extending with the elongate tubular member, wherein the lumen 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) 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)
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 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 comprises a circumferential disposition (conductive silicone layer 88 has a circumferential disposition).
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, a first geometric line extending in the cross-section intersects a geometric center of the elongate tubular member and the cutting edge, a second geometric line extending in the cross-section is perpendicular to the first geometric line and intersect the geometric center, and no portion of the conductive material portion overlaps the second geometric line. 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 circumferential exposure of the conductive material portion that is slightly less than half the circumference, and on where within a cross-section perpendicular to a longitudinal axis of the elongate tubular member, a first geometric line extending in the cross-section intersects a geometric center of the elongate tubular member and the cutting edge, a second geometric line extending in the cross-section is perpendicular to the first geometric line and intersect the geometric center, and no portion of the conductive material portion overlaps the second geometric line as shown in annotated Fig. 5.
PNG
media_image3.png
745
1538
media_image3.png
Greyscale
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).
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), as applied to claims 1 & 19, in further view of Winkler (5,417,208, previously cited).
Concerning claims 3-4¸Rydell fails 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 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) in view of Winkler (5,417,208, previously cited), as applied to claim 4, in further view of Tegg et al. (2008/0161761, previously cited).
Concerning claim 5, Rydell in view of Winkler fails 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 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), as applied to claim 1, in further view of Swanson et al. (5,991,650, previously cited).
Concerning claim 7, Rydell fails 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 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 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), as applied to claim 1, in further view of Habib et al. (2010/0049191, previously cited).
Concerning claim 10, Rydell fails to disclose the return wire is an integral part of the elongate tubular member. However, Habib et al. disclose a medical device comprising an electrical conductor (17) that may either be embedded in the wall of an elongated tubular member, or mounted in a channel within the wall of the elongated tubular member. 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 return wire is an integral part of the elongate tubular member since Habib et al. teach embedding a conductor wire to be an equivalent in the art for the predictable result of connecting a distal electrode to a proximal energy source. ([0023])
Claim 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696, previously cited), as applied to claim 1, in further view of McGaffigan (2004/0015162, previously cited).
Concerning claim 12, Rydell fails 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 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), as applied to claim 1, in further view of Salahieh et al. (2012/0071870, previously cited).
Concerning claim 14, Rydell fails to disclose the specifics of the thickness, particles, viscosity, or longitudinal resistance of the conductive ink. 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 ink 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 material 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), 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 fails 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 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), 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 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 causes 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 causes 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 of Rydell 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 causes 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
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,844,407 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; 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 the conductive material portion circumferentially extends less than halfway around the elongate tubular member. However, Rydell discloses a conductive material portion (92) that extends less than halfway around the elongate tubular member (12) (Col. 5, ll. 10-37).
PNG
media_image2.png
342
857
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of the patent such that the conductive material portion circumferentially extends less than halfway around the elongate tubular member as taught by Rydell in Fig. 8 and is thus of whatever desired or expedient size, since Applicant places no criticality on the size (Par. [0046]: “Figs. 2 and 3 show that the circumferential disposition of the conductive ink portion 126 extends about halfway around the tubular member (i.e., the dotted line 208, 308 extends through the center or origin of the tubular member 102)…[i]n alternative configurations, the circumferential disposition of the conductive ink portion 126 may extend less than halfway or more than halfway around the tubular member” 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) 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, wherein the conductive material portion comprises a circumferential disposition (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 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 patent 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).
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of co-pending application nos. 18/385698 & and claims 1-20 18/497767 (noting claims are substantial duplicates in the listed co-pending applications) 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 (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). The co-pending application nos. fail to disclose the conductive material portion circumferentially extends less than halfway around the elongate tubular member. However, Rydell discloses a conductive material portion (92) that extends less than halfway around the elongate tubular member (12) (Col. 5, ll. 10-37).
PNG
media_image2.png
342
857
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the invention of the patent such that the conductive material portion circumferentially extends less than halfway around the elongate tubular member as taught by Rydell in Fig. 8 and is thus of whatever desired or expedient size, since Applicant places no criticality on the size (Par. [0046]: “Figs. 2 and 3 show that the circumferential disposition of the conductive ink portion 126 extends about halfway around the tubular member (i.e., the dotted line 208, 308 extends through the center or origin of the tubular member 102)…[i]n alternative configurations, the circumferential disposition of the conductive ink portion 126 may extend less than halfway or more than halfway around the tubular member” 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, wherein the conductive material portion comprises a circumferential disposition (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 co-pending application nos. fail to disclose the circumferential disposition in which, within a cross-section perpendicular to a longitudinal axis of the elongate tubular member, a first geometric line extending in the cross-section intersects a geometric center of the elongate tubular member and the cutting edge, a second geometric line extending in the cross-section is perpendicular to the first geometric line and intersects the geometric center, and no portion of the conductive material portion overlaps the second geometric line. 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, which, within a cross-section perpendicular to a longitudinal axis of the elongate tubular member, a first geometric line extending in the cross-section intersects a geometric center of the elongate tubular member and the cutting edge, a second geometric line extending in the cross-section is perpendicular to the first geometric line and intersects the geometric center, and no portion of the conductive material portion overlaps the second geometric line. At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the co-pending application nos. 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, a first geometric line extending in the cross-section intersects a geometric center of the elongate tubular member and the cutting edge, a second geometric line extending in the cross-section is perpendicular to the first geometric line and intersects the geometric center, and no portion of the conductive material portion overlaps the second geometric line, 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).
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 ink 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.
In response to Applicant’s arguments that Fig. 8 shows polymer 92 extending halfway, not less than halfway, around the tube 12, the Examiner respectfully disagrees. Rydell teaches the side wall of the lumen 82/84 is ground away to expose conductive polymer 92 that fills either of lumen 82 or 84. Since there is an interior wall splitting the tube 12 into the two lumens, anything that fills either of the lumens 82/84, would not extend halfway as shown in annotated Fig. 5 in a magnified view:
PNG
media_image4.png
1006
1408
media_image4.png
Greyscale
From Fig. 5, it is physically impossible for the conductive polymer to circumferentially extend halfway or more due to the interior lumen wall separating the lumens 82, 84.
In response to Applicant’s arguments that Rydell fails to disclose the newly amended limitation of claim 19, the Examiner respectfully disagrees. As shown in the annotated Fig. 5 in the rejection of claim 19 (copied below), the exposed area of lumen 82/84 is less than half the circumferential area of the tube
PNG
media_image3.png
745
1538
media_image3.png
Greyscale
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights