DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
3. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
4. Claims 1-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kachaamy U.S. 2020/0375656 (herein referred to as “Kachaamy” and in view of Sharma U.S. U.S. 2023/0372007 (herein referred to as “Sharma”).
5. Regarding Claim 1, Kachaamy teaches a sphincterotome (Fig. 5, ref num 100) with two guide wires (Fig. 8, ref num 142, 152) and four cavities (Fig. 8, ref num 124, 134, 144, 154), comprising
a. a handle assembly (Fig. 5, ref num 110), a sheath-tube assembly (Fig. 5, ref num 104) and a head assembly which are connected in sequence (Fig. 5, ref num 106; para 0025),
b. the handle assembly comprising a handle body (Fig. 5, ref num 110 has a handle body) an electrode being connected with a cutting wire (Fig. 5, ref num 116; para 0025, “The cutting wire 116 may comprise a conductor”),
c. wherein the sheath-tube assembly comprises a four-cavity tube internally (Fig. 8, ref nums 124, 134, 144, 154) provided with an injection cavity (Fig. 8, ref num 124), a cutting wire cavity (Fig. 8, ref num 114) and two guide wire cavities which axially run through the four-cavity tube (Fig. 8, ref nums 144, 154), and
d. an injection inlet communicating with the injection cavity (Fig. 5, ref num 120; para 0034) and two guide wire inlets communicating with the two guide wire cavities are formed in the four-cavity tube (Fig. 5, ref num 140, 150; para 0027);
e. the head assembly comprises a head tube (Fig. 6, ref num 106 has a head tube), and an injection outlet (fig. 6, ref num 126) communicating with the injection cavity (para 0031, 0034, “proximal fluid lumen 124 fluidly connects the proximal fluid entry port 120 with the proximal fluid exit port 126”) and two guide wire outlets communicating with the two guide wire cavities are formed in the head tube (Fig. 7, ref num 146, 156; para 0029-0030);
f. and one end, away from the electrode, of the cutting wire passes through the cutting wire cavity to protrude from the head tube, and is fixedly connected to the head tube (see Fig. 6, ref num 116 protrudes from the head tube, and is fixedly connected to ref num 106).
Kachaamy fails to teach the electrode arranged on the handle body.
Sharma teaches a device of analogous art (Fig. 1), wherein the device comprises an electrode (Fig. 3, ref num 38) arranged on a handle body (Fig. 3, ref num 38 arranged on handle, ref num 28). This provides an electrical connection to cutting wire (para 0060, “an electrical connection 38 for an energy source (e.g., a radiofrequency energy source, or the like) to energize the wire filament 30 and facilitate cutting tissue”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kachaamy to have arranged the electrode on the handle body in order to produce the same expected result of providing energy to the cutting wire to facilitate cutting.
6. Regarding Claim 2, Kachaamy fails to teach an outer diameter of the head tube is gradually decreased from the sheath-tube assembly to an end, away from the four-cavity tube, of the head tube, and the end of the head tube is hemispherical.
However, it would have been an obvious matter of design choice to have the outer diameter gradually decrease from the sheath-tube assembly to an end, 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). It also would have been an obvious matter of design choice to make the different portions of the head tube whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
7. Regarding Claim 3, Kachaamy teaches the injection inlet is an injection connector arranged on the four-cavity tube and communicating with the injection cavity (para 0026, “fluid can be provided at the proximal fluid entry port 120 for infusion”); the two guide wire inlets comprise a first guide wire connector and a second guide wire connector (Fig. 5, ref num 140, 150), the two guide wire cavities comprise a first guide wire cavity and a second guide wire cavity (Fig. 8, ref num 144, 154), the first guide wire connector communicates with the first guide wire cavity (para 0027, “proximal guidewire entry port 140”; para 0034), and the second guide wire connector communicates with the second guide wire cavity (para 0027, 0034); and the two guide wire outlets comprise a first guide wire outlet and a second guide wire outlet (Fig. 6, ref num 146, 156), the first guide wire outlet communicates with the first guide wire cavity (para 0030), and the second guide wire outlet communicates with the second guide wire cavity (para 0029).
8. Regarding Claim 4, Kachaamy teaches the first guide wire outlet and the injection outlet are arranged on the end, away from the four-cavity tube, of the head tube (Fig. 7, ref num 146 and 126 are arranged on one end away from the four-cavity tube end), the second guide wire outlet is arranged on a side of the head tube (see Fig. 7, ref num 156 is arranged on a side of the head tube), and a distance between the first guide wire outlet and the second guide wire outlet is 3-5 mm (para 0030, “proximal guidewire exit port 146 can be on a cutting wire side of the shaft 160, e.g., approximately 0.2 to 0.25 inches (approximately 0.5 to 1.0 centimeters) away from the distalmost tip of the shaft 160”; 0.5 cm is equal to 5 mm, therefore, the distance falls within the range).
9. Regarding Claim 5, Kachaamy teaches the handle body comprises a core bar (Fig. 5, ref num 112), an other end of the core bar is provided with the end cap (see Fig. 5, ref num 106 is on an end of ref num 112), the core bar is provided with a sliding handle (Fig. 5, ref num 112 is a sliding handle; para 0025); and the head tube is made of a bendable material (Fig. 5, ref num 106 is the head tube; para 0033 describes the bendable material that ref num 106 is made of).
Kachaamy fails to teach one end of the core bar is provided with a thumb ring, and the four-cavity tube is fixedly connected to the end cap; the sliding handle is provided with an electrode holder and the electrode is mounted on the electrode holder.
Sharma teaches the handle assembly comprises a core bar (Fig. 3, ref num 28a) and one end of the core bar is provided with a thumb ring (Fig. 3, ref num 28b). Sharma also teaches a tube that is fixedly connected to an end cap of the core bar (Fig. 3, ref num 26 is connected to end cap 46). The handle assembly may also include a sliding handle (Fig. 3, ref num 28a) wherein an electrode holder with the electrode mounted thereon is provided therein (Fig. 3, ref num 38). This configuration allows the user to position the distal end of the device, or the cutting wire, relative to the target tissue (para 0054-0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kachaamy to configure the handle assembly as described above in order to position the cutting wire relative to the target tissue.
10. Regarding Claim 7, Kachaamy teaches a notch is formed at the second guide wire outlet (Fig. 6, ref num 156, it is understood there is a notch/opening and the guide wire outlet). Kachaamy fails to explicitly teach that the notch is arc-shaped. However, it would have been an obvious matter of design choice to make the notch whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
11. Regarding Claim 8, Kachaamy teaches a distance from the first guide wire connector communicating with the first guide wire outlet to the end of the head tube is larger than a distance from the second guide wire connector to the end of the head tube (see Figs. 5 and 6, the distance between ref num 140 to the end of ref num 160 is greater than the distance between ref num 150 and the end of ref num 160 because ref num 140 is positioned proximally to ref num 150; therefore, it is understood that the distance would be greater; para 0027).
12. Regarding Claim 9, Kachaamy teaches the four-cavity tube is of a circular structure (see Fig. 8), the four-cavity tube is provided with a first symmetry axis and a second symmetry axis vertical to each other (see Fig. 8, there are two axes of symmetry), the first guide wire cavity and the second guide wire cavity are symmetrically arranged on both sides of the first symmetry axis respectively (see Fig. 8, ref num 144 and 154 are arranged on both sides of the first symmetry axis), and the injection cavity and the cutting wire cavity are symmetrically arranged on both sides of the second symmetry axis respectively (see Fig. 8, ref nums 124, 134 are arranged on both sides of the second symmetry axis).
13. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kachaamy and Sharma, and further in view of Slanda WO 99/17669 (herein referred to as “Slanda”).
14. Regarding Claim 6, Kachaamy fails to teach one end, close to the thumb ring, of the sliding handle is provided with a limiting block slidably arranged on the core bar.
Slanda teaches a device of analogous art (Fig. 4), wherein the handle assembly comprises that one end, close to a thumb ring, of the sliding handle is provided with a limiting block slidable arranged on the core bar (Fig. 7, ref num 90). This limits the movement of the sliding handle in order to properly manipulate the device to the target tissue (pg. 15, lines 20-34). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kachaamy to include a limiting block in order to limit the movement of the device so that the cutting wire is placed at the target tissue.
15. Claims 10-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kachaamy and Sharma, and further in view of McLawhorn U.S. 2025/0235259 (herein referred to as “McLawhorn”).
16. Regarding Claim 10, Kachaamy fails a section, close to the head tube, of the cutting wire is an exposed section (see Fig. 6, ref num 116 is exposed close to ref num 106).
Kachaamy fails to teach an insulating sleeve sleeves on the cutting wire.
McLawhorn teaches a device of analogous art (Fig. 1), wherein an insulating sleeve sleeves on the cutting wire (Fig. 1, ref num 148 insulates cutting wire, ref num 124; para 0033, “The cover 148 may serve as and also be referred to as a protector, in that it insulates and/or protects tissue from coming into contact with and being cut by the portion of the cutting edge 124 being covered by the cover 148”). This improves the cutting ability of the cutting wire (para 0033). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kachaamy to include an insulting sleeve on the cutting wire in order to improve the cutting ability of the cutting wire.
17. Regarding Claim 11, Kachaamy fails to teach an outer diameter of the head tube is gradually decreased from the sheath-tube assembly to an end, away from the four-cavity tube, of the head tube, and the end of the head tube is hemispherical.
18. Regarding Claim 12, Kachaamy teaches the injection inlet is an injection connector arranged on the four-cavity tube and communicating with the injection cavity (Fig. 5, ref num 120 is an injection connector that communicates with ref num 124); the two guide wire inlets comprise a first guide wire connector and a second guide wire connector (Fig. 5, ref num 140, 152 are each connectors), the two guide wire cavities comprise a first guide wire cavity and a second guide wire cavity (Fig. 8, ref num 144, 154), the first guide wire connector communicates with the first guide wire cavity (ref num 140 communicates with ref num 144; para 0027), and the second guide wire connector communicates with the second guide wire cavity (ref num 150 communicates with ref num 154; para 0027); and the two guide wire outlets comprise a first guide wire outlet and a second guide wire outlet (Fig. 6, ref num 146, 156), the first guide wire outlet communicates with the first guide wire cavity (para 0029-0030), and the second guide wire outlet communicates with the second guide wire cavity (para 0029-0030).
19. Regarding Claim 13, Kachaamy teaches the first guide wire outlet and the injection outlet are arranged on the end, away from the four-cavity tube, of the head tube (Fig. 7, ref num 146 and 126 are arranged on one end away from the four-cavity tube end), the second guide wire outlet is arranged on a side of the head tube (see Fig. 7, ref num 156 is arranged on a side of the head tube), and a distance between the first guide wire outlet and the second guide wire outlet is 3-5 mm (para 0030, “proximal guidewire exit port 146 can be on a cutting wire side of the shaft 160, e.g., approximately 0.2 to 0.25 inches (approximately 0.5 to 1.0 centimeters) away from the distalmost tip of the shaft 160”; 0.5 cm is equal to 5 mm, therefore, the distance falls within the range).
20. Regarding Claim 14, Kachaamy teaches the handle body comprises a core bar (Fig. 5, ref num 112), an other end of the core bar is provided with the end cap (see Fig. 5, ref num 106 is on an end of ref num 112), the core bar is provided with a sliding handle (Fig. 5, ref num 112 is a sliding handle; para 0025); and the head tube is made of a bendable material (Fig. 5, ref num 106 is the head tube; para 0033 describes the bendable material that ref num 106 is made of).
Kachaamy fails to teach one end of the core bar is provided with a thumb ring, and the four-cavity tube is fixedly connected to the end cap; the sliding handle is provided with an electrode holder and the electrode is mounted on the electrode holder.
Sharma teaches the handle assembly comprises a core bar (Fig. 3, ref num 28a) and one end of the core bar is provided with a thumb ring (Fig. 3, ref num 28b). Sharma also teaches a tube that is fixedly connected to an end cap of the core bar (Fig. 3, ref num 26 is connected to end cap 46). The handle assembly may also include a sliding handle (Fig. 3, ref num 28a) wherein an electrode holder with the electrode mounted thereon is provided therein (Fig. 3, ref num 38). This configuration allows the user to position the distal end of the device, or the cutting wire, relative to the target tissue (para 0054-0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kachaamy to configure the handle assembly as described above in order to position the cutting wire relative to the target tissue.
21. Regarding Claim 16, Kachaamy teaches a notch is formed at the second guide wire outlet (Fig. 6, ref num 156, it is understood there is a notch/opening and the guide wire outlet). Kachaamy fails to explicitly teach that the notch is arc-shaped. However, it would have been an obvious matter of design choice to make the notch whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
22. Regarding Claim 17, Kachaamy teaches a distance from the first guide wire connector communicating with the first guide wire outlet to the end of the head tube is larger than a distance from the second guide wire connector to the end of the head tube (see Figs. 5 and 6, the distance between ref num 140 to the end of ref num 160 is greater than the distance between ref num 150 and the end of ref num 160 because ref num 140 is positioned proximally to ref num 150; therefore, it is understood that the distance would be greater; para 0027).
23. Regarding Claim 18, Kachaamy teaches the four-cavity tube is of a circular structure (see Fig. 8), the four-cavity tube is provided with a first symmetry axis and a second symmetry axis vertical to each other (see Fig. 8, there are two axes of symmetry), the first guide wire cavity and the second guide wire cavity are symmetrically arranged on both sides of the first symmetry axis respectively (see Fig. 8, ref num 144 and 154 are arranged on both sides of the first symmetry axis), and the injection cavity and the cutting wire cavity are symmetrically arranged on both sides of the second symmetry axis respectively (see Fig. 8, ref nums 124, 134 are arranged on both sides of the second symmetry axis).
24. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kachaamy and Sharma, and further in view of McLawhorn and Slanda.
25. Regarding Claim 15, Kachaamy fails to teach one end, close to the thumb ring, of the sliding handle is provided with a limiting block slidably arranged on the core bar.
Slanda teaches a device of analogous art (Fig. 4), wherein the handle assembly comprises that one end, close to a thumb ring, of the sliding handle is provided with a limiting block slidable arranged on the core bar (Fig. 7, ref num 90). This limits the movement of the sliding handle in order to properly manipulate the device to the target tissue (pg. 15, lines 20-34). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kachaamy to include a limiting block in order to limit the movement of the device so that the cutting wire is placed at the target tissue.
Conclusion
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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