DETAILED ACTION
The following is a First Action, 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121 & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 15/845550, 14/139214 & 61/746162 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 12/27/2012
Specification
The disclosure is objected to because of the following informalities: amend Par. [0001] to include updated status information for 15/845550.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “extends” to -extending- in ll. 4. Appropriate correction is required.
Claims 16, 17 & 18 are objected to because of the following informalities: amend “causes” to -is configured to cause- in ll. 2 (claims 16 & 17) or 4 (claim 18). Appropriate correction is required.
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 3-6, 14 & 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the conductive ink" in ll. 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be interpreted as -the conductive cannula electrically coupling the conductive material portion to the return wire, wherein the conductive material portion comprises a conductive ink portion-.
Claims 4-6 depend from claim 1 and are thus also rejected.
Claim 14 recites the limitation "where the conductive ink portion has a viscosity less than or equal to about 10,000 centipoise". It is unclear how the ink can have a viscosity on the device since this would indicate that during use, the ink could flow off the device. The Examiner notes that the limitation 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 14 recites the limitation "the conductive ink portion" in ll. 5. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be interpreted as -the conductive material portion-.
Claim 20 recites the limitation "the conductive ink" in ll. 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be interpreted as -the conductive cannula electrically coupling the conductive material portion to the return wire, wherein the conductive material portion comprises a conductive ink portion-.
Claim Interpretation
Claim 14 recites the limitation "wherein the conductive ink 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 ink along the length of the ink.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2, 8-9, 11, 13 & 19 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Rydell (5,035,696).
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 past aperture 28; Col. 3, ll. 37-64).
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, or near, aperture 28; Col. 3, ll. 37-64).
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).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3-4 & 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rydell (5,035,696), as applied to claims 1 & 19, in further view of Winkler (5,417,208).
Concerning claims 3-4 & 20¸Rydell fails to disclose a conductive cannula disposed about the outer surface of the elongate tubular member, the conductive cannula electrically coupling the conductive ink portion to the return wire, wherein at least a portion of the conductive ink portion is further disposed over at least a portion of the conductive cannula to electrically couple the conductive ink 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 ink portion to the return wire, wherein at least a portion of the conductive ink portion is further disposed over at least a portion of the conductive cannula to electrically couple the conductive ink 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) in view of Winkler (5,417,208), as applied to claim 4, in further view of Tegg et al. (2008/0161761).
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), as applied to claim 1, in further view of Swanson et al. (5,991,650).
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), as applied to claim 1, in further view of Habib et al. (2010/0049191).
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), as applied to claim 1, in further view of McGaffigan (2004/0015162).
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), as applied to claim 1, in further view of Salahieh et al. (2012/0071870).
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 ink 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 ink 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), as applied to claim 1, in further view of Hebborn (5,480,399).
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) in view of Hebborn (5,480,399), as applied to claim 15, in further view of Shilev (2010/0331835) and Brannan (2011/0208184).
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
Claims 1-20 of this application are patentably indistinct from claims 1-20 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 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 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 1-20 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. 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). 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 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). 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).
Claims 1-20 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). 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 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). 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).
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 ink portion to the return wire”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Eggers et al. (5,843,019) teach a conductive shaft as a return electrode. Newton et al. (4,416,277) teach a return electrode monitoring system to detect a split or solid electrode.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794