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.
Specification
3. The disclosure is objected to because of the following informalities: in paragraph 0014, the temperature “F” is not preceded with any temperature scale indication such as the work “degree” or symbol “o”. Appropriate correction is required.
Claim Objections
4. Claim 14 is objected to because of the following informalities: the term “Fahrenheit” is not preceded with any temperature scale indication such as the work “degree” or symbol “o”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 3, 19, and 25, as well as claims 20-24 based on their dependency to independent claim 19, 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.
7. Claim 3 recites the limitation "the needle" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 3 is dependency from Claims 2 and 1, where there is no recitation of a “needle”. This renders the claim indefinite. Based on context of the claim language and specification, for examination purposes, “the needle” will be interpreted as “the retrieval portion”. Proper correction is required.
8. The phrase “at least near-continuous perimeter” in Claims 19 and 25 contains a relative term, which renders the claim indefinite. The term “near-continuous” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Is unclear as to whether “at least near-continuous” means that the perimeter may not be continuous whatsoever, or if this is considered a range, meaning a continuous perimeter would read on the claim. It is also unclear as to what “near-continuous” would be defined as. For examination purposes, a “continuous perimeter”, like recited in Claim 1, will read on the claim language. Proper correction is required.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mandavia U.S. 11,207,120 (herein referred to as “Mandavia”) and in view of Woloszko U.S. 2005/0251134 (herein referred to as “Woloszko”).
11. Regarding Claim 1, Mandavia teaches a tip portion (Fig. 1A, ref nums 106, 103) for a cautery device (Fig. 1A, ref num 100) defining a device axis (Fig. 1A, ref num 101), the tip portion comprising:
a. a first electrode (Fig. 1B, ref num 107) and a second electrode (Fig. 1B, ref num 108), wherein the first electrode and the second electrode are spaced apart (see Fig. 1B, ref nums 107 and 108 are spaced apart); and
b. at least one wire (Fig. 1B, ref num 104) comprising:
b.1 a first end in electrical connection with the first electrode (Fig. 1B, ref num 104a is connected at proximal end, ‘PER-1’ to ref num 107; Col. 8, lines 50-53, “The proximal ends PER-1, PER-2 of the electrically conductive rods 107, 108 are mechanically and electrically coupled to the two ends 104a, 104b of the electrode 104”);
b.2 a second end in electrical connection with the second electrode (Fig. 1B, ref num 104b is connected at proximal end, ‘PER-2’ to ref num 108; Col. 8, lines 50-53, “The proximal ends PER-1, PER-2 of the electrically conductive rods 107, 108 are mechanically and electrically coupled to the two ends 104a, 104b of the electrode 104”); and
b.3 a central portion (Fig. 1B, ref num 104c) in electrical communication with the first electrode and the second electrode (since the first and second ends of the wire, ref nums 104a and 104b, are electrically connected to ref nums 107, 108, then the electrical connection of ref num 104c to ref nums 104a, 104b would indicate an electrical connection between ref nums 107 and 108 as well; Col. 8, lines 45-58; Col. 7, lines 62-64; Col. 12, lines 40-43), wherein the central portion defines a cautery shape (Col. 5, line 16, “forming a tip for cauterizing tissue when heated” indicates that the central portion has a cautery shape), wherein the cautery shape comprises a continuous perimeter extending in a cautery plane (Fig. 1B, ref num 104c has a continuous perimeter when connected to ref nums 104a and 104b), and
While Mandavia teaches that the wire portion may have a variety of shapes, such as an angled-ball electrode (Col. 8, lines 18-29), Mandavia fails to explicitly teach that the cautery plane is angled relative to the device axis.
Woloszko teaches a tip portion of analogous art (Figs. 27-29), wherein the tip portion comprises a cautery plane (Fig. 29, ref nums 724/726) that is angled relative to the device axis (Fig. 27, ref nums 740 and 750 define the device axis; see Figs. 27 and 29, ref nums 724/726 are angled relative to the device axis; para 0130, “active electrode 724 and return electrode 726 are arranged at an acute angle .beta. with respect to the longitudinal axis of the probe 700”). It would have been an obvious matter of design choice to make the different portions cautery shape/plane whatever form or shape was desired or expedient, such as angling the cautery plane relative to the device axis. 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.
12. Regarding Claim 13, another embodiment of Mandavia teaches the retrieval portion is configured to provide suction (Col. 13, lines 57-67 – Col. 14, line 1, “the fan 417 is positioned within the housing 405… induce a negative pressure and draft… an evacuation system 419”).
13. Regarding Claim 14, Mandavia fails to explicitly teach the cautery shape defines a circle, oval, or diamond.
Woloszko teaches the cautery shape defines a circle, oval, or diamond (para 0128, “active electrode 724 and return electrode 726 may each have various shapes, such as semicircular or U-shaped”; para 0134, “other cross-sectional shapes for active electrode 724 and return electrode 726 are possible”). It would have been an obvious matter of design choice to make the different portions cautery shape/plane 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.
14. Regarding Claim 15, Mandavia teaches the first electrode and the second electrode are configured to cause the wire to heat to a temperature between 700F-1300F (Col. 4, lines 14-28, “generates a flow of current through the tip for heating thereof to a temperature… a flow of current through the electrode for heating thereof to an elevated temperature suitable for cauterizing tissue, e.g., an elevated temperature in a range of about 400 oC. to about 1300 oC., and preferably in a range of about 750 oC. to about 1300 oC.”; 700 oF to 1300 oF is equivalent to approx. 372 oC to 704 oC).
15. Regarding Claim 16, Mandavia teaches the temperature is between 700F-1300F (Col. 4, lines14-28), therefore, it would read on that the temperature is below a burning temperature of a vascular graft.
16. Regarding Claim 17, Mandavia fails to teach the cautery plane is perpendicular relative to the device axis.
Woloszko teaches the cautery plane (Fig. 29, ref nums 724/726) that is angled relative to the device axis (Fig. 29, ref nums 724/726) that is angled relative to the device axis (Fig. 27, ref nums 740 and 750 define the device axis; see Figs. 27 and 29, ref nums 724/726 are angled relative to the device axis; para 0130 describes the angle). The cautery plane may be perpendicular relative to the device axis (para 0116, “tissue-contacting portion of the loop electrodes having a right angle (90%) orientation”; see Fig. 13, the cautery plane is perpendicular. It would have been an obvious matter of design choice to make the different portions cautery shape/plane whatever form or shape was desired or expedient, such as angling the cautery plane relative to the device axis. 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.
17. Regarding Claim 18, Mandavia fails to teach the cautery plane extends at an angle within a range of 45o – 90o relative to the device axis.
Woloszko teaches a tip portion of analogous art (Figs. 27-29), wherein the tip portion comprises a cautery plane (Fig. 29, ref nums 724/726) that is angled relative to the device axis (Fig. 27, ref nums 740 and 750 define the device axis; see Figs. 27 and 29, ref nums 724/726 are angled relative to the device axis; para 0130, “active electrode 724 and return electrode 726 are arranged at an acute angle .beta. with respect to the longitudinal axis of the probe 700”), such that the angle is within a range of 45o – 90o relative to the device axis (para 0130, “angle .beta. is in the range of from about 45o to 85o”). It would have been an obvious matter of design choice to make the different portions cautery shape/plane whatever form or shape was desired or expedient, such as angling the cautery plane relative to the device axis. 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.
18. Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mandavia and Woloszko, and further in view of Witt U.S. 2019/0099213 (herein referred to as “Witt”).
19. Regarding Claim 2, in another embodiment of Mandavia, they teach a retrieval portion (Fig. 4, ref num 410 and 419; Col. 13, lines 56-67 – Col. 14, lines 1-4). However, the embodiments of Mandavia fail to explicitly teach that the retrieval portion is positioned between the first electrode and second electrode.
Witt teaches a tip portion of analogous art (Fig. 2), wherein the tip portion comprises a first and second electrode (Figs. 1 and 2, ref num 145a and 145b; para 0070, “electrodes 145a,b”) and a retrieval portion (Fig. 1, ref num 165; para 0073, “mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110”). The retrieval portion is positioned between the first and second electrode (see Figs. 2 and 5, ref num 165 is between ref nums 145a, 145b). The retrieval portion provides means to remove unwanted debris and fluid from the target site during treatment (para 0073, “mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110. The liquid mixture may then be removed from the electrosurgical device 100”). By providing the retrieval portion, the user may cauterize and remove tissue remnants as needed (para 0033, “incorporating coagulation and aspiration function is desirable”). 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 Mandavia to include a retrieval portion between the first and second electrode in order to remove unwanted debris from the target site while achieving the same desired result of cauterizing tissue. Also, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the retrieval portion between the first and second electrodes, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
20. Regarding Claim 3, Mandavia teaches a stabilizer (Fig. 1A, ref num 102), wherein the first electrode and the second electrode extend through the stabilizer (see Figs. 1A, 1B, 1C, ref nums 104, 107, 108 extend through ref num 102; Col. 9, lines 22-36 describes that the conducting elements, ref nums 120, 130, which ref nums 107 and 108 make up part of, extend through ref num 102). Another embodiment of Mandavia also teaches that the retrieval portion (Fig. 4, ref num 417) extends through the housing (Fig. 4, ref num 405).
While, Mandavia fails to explicitly teach the stabilizer is configured to maintain spacing between the first and second electrodes, it is understood that the channels (Fig. 1d, ref nums 107-C and 108-C) that are part of the stabilizer (Fig. 1D, ref num 102) are configured to maintain the spacing between the first and second electrodes (see Fig. 1D, there is space between 107 and 108). 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 understood that the electrodes of Mandavia maintain space between them in order to produce the same expected result of the invention.
21. Regarding Claim 4, Mandavia fails to teach the retrieval portion extends along and is moveable along a retrieval axis.
Witt teaches the retrieval portion (Fig. 2, ref num 165) extends along and is moveable along a retrieval axis (see Fig. 14, ref num 165 is in the extended configuration; para 0074, “the slide switch 130, in a first portion (for example, in a proximal position), may cause the aspiration tube 160 to remain in a first or retracted position… the slide switch 130 in a second position (for example in a distal position), may cause the aspiration tube 160 to extend in a distal direction to a fully extended position”). This allows control over when the retrieval portion is used to retrieve the debris from the target site (para 0067, 0074). 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 Mandavia to have the retrieval portion moveable along a retrieval axis in order to control the removal of debris.
22. Regarding Claim 5, Mandavia fails to teach at least one shuttle connected to the retrieval portion and moveable along the retrieval axis to enable movement of the retrieval portion between a retracted position and an extended position.
Witt teaches at least one shuttle (Figs. 1, 18, and 22, ref num 130) connected to the retrieval portion (para 0074, “the aspiration tube control device may comprise a slide switch 130”) and moveable along the retrieval axis (see Figs. 18 and 22, the movement of ref num 130 is in the same axis as ref num 165/160) to enable movement of the retrieval portion between a retracted position and an extended position (Figs. 18 and 22 show retracted and extended positions of ref num 165/160; para 0078 describes the movement of the retrieval portion relative to the shuttle). This allows control over when the retrieval portion is used to retrieve the debris from the target site (para 0067, 0074). 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 Mandavia to have the retrieval portion moveable between a retracted and extended position, via a shuttle, in order to control the removal of debris.
23. Regarding Claim 6, Mandavia fails to teach when the retrieval portion is in the extended position, a tip of the retrieval portion extends past the cautery plane.
Witt teaches when the retrieval portion is in the extended position (Figs. 14 and 18, ref num 165 is in the extended position), a tip of the retrieval portion extends past the cautery plane (Fig. 14, ref num 165 tip extends past ref nums 145a, 145b, which perform the cautery function, therefore, the tip of 165 extends beyond that plane). This allows control over when the retrieval portion is used to retrieve the debris from the target site when in the extended position (para 0067, 0074). 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 Mandavia to have the retrieval portion extend beyond the cautery plane in order to control the removal of the debris from the target site.
24. Claims 7, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mandavia, Woloszko, and Witt, and further in view of Robinson U.S. 5,573,008 (herein referred to as “Robinson”).
25. Regarding Claim 7, Mandavia fails to teach when the retrieval portion is in the extended position, the tip of the retrieval portion extends through the continuous perimeter of the cautery shape.
Robinson teaches a tip portion of analogous art (Fig. 4), wherein the tip portion comprises a wire that defines a cautery shape (Fig. 4, ref num 64; Col. 5, lines 61-62, “a wire-form cutting loop 64”), such that the cautery shape has a continuous perimeter (see Fig. 4, ref num 64 has a continuous perimeter). The tip portion also comprises a retrieval portion (Fig. 4, ref num 54), such that when the retrieval portion is in an extended position (see Fig. 4a), the tip of the retrieval portion extends through the continuous perimeter of the cautery shape (Figs. 4 and 4a display ref num 54 in an extended position, such that it extends through the perimeter of ref num 64). This is to come into contact with the tissue for retrieval purposes (Col. 6, lines 12-14, “the retractor 54 is extended distally (arrow 66) so it pierces the tissue surface 18”). By extending the retrieval portion through the perimeter, this brings the tissue into an area where it may be cut/cauterized (Col. 2, lines 65-67 – Col. 1, lines 1-3; see Figs. 4a-4e). 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 Mandavia to have the retrieval portion extend through the perimeter of the cautery shape in order to bring the tissue into the area desired for cutting and cauterization.
26. Regarding Claim 11, Mandavia fails to teach the retrieval portion is barbed.
Robinson teaches a retrieval portion is barbed (Fig. 3, ref num 40/42; Col. 5, lines 12-15, “The retractor member is axially movable (arrow 41), is formed of an extended length, and has a barbed tip 42 for piercing and retaining samples during axial travel”). It would have been an obvious matter of design choice to make the different portions retrieval portion 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.
27. Regarding Claim 12, Mandavia fails to teach the retrieval portion is a needle.
Robinson teaches a retrieval portion that is a needle (Fig. 4, ref num 54; Col. 5, line 51, “retractor 54, preferably a spear-form element”). It would have been an obvious matter of design choice to make the different portions retrieval portion 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.
28. Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mandavia, Woloszko, and Witt, and further in view of Hayakawa U.S. 2018/0256179 (herein referred to as “Hayakawa”).
29. Regarding Claim 8, Mandavia fails to teach at least one biasing element configured to bias the retrieval portion to the retracted position.
Hayakawa teaches a tip portion of analogous art (Figs. 4A, 4B, 6A, 6B, 12a, and 12B), wherein the tip portion comprises a wire (Fig. 4B, ref num 30) and a retrieval portion (Fig. 6B, ref num 40/42). The retrieval portion may be configured in a retracted and extended position (Figs. 6A and 6B, ref num 40 is in retracted and extended positions, respectively), such that at least one biasing element (Figs. 12A and 12B, ref num 61) is configured to bias the retrieval portion to the retracted position (once the biasing element, i.e. balloon ref num 61, has been deflated and removed, this subsequently causes the retrieval portion, ref num 40/42, to be withdrawn into the retracted position; see para 0073-0074). This biasing element provides the advantage of positioning the target tissue within the cautery/cutting plane in order to perform the expected result of cutting the tissue (para 0031). 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 Mandavia to include a biasing element to bias the retrieval portion to the retracted position in order to cut and capture the target tissue.
30. Regarding Claim 9, Mandavia fails to teach the retrieval portion extends through the cautery plane, the retrieval portion is configured to pass through a medium being cut, wherein the bias of the biasing element causes the retrieval portion to pull the medium toward the at least one wire.
Hayakawa teaches the retrieval portion extends through the cautery plane (see Fig. 12A, ref num 42 extends beyond plane of ref num 30), the retrieval portion is configured to pass through a medium being cut (see Fig. 12B, ref num 42 extends through ref character “T”), wherein the bias of the biasing element causes the retrieval portion to pull the medium toward the at least one wire (see Figs. 12A and 12B, ref num 61 biases the medium, ref character “T”, within ref num 40 towards ref num 30; para 0070, “balloon 61 is moved to the proximal side in the blood vessel… the thrombi T are pushed by the balloon 61 and guided into the capturing portion 42”; para 0071, “the cutting unit 32 is rotated inside the capturing portion 42”). This brings the medium into position for it to be cut (para 0070). 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 Mandavia to have the biasing element pull the medium toward the wire for cutting, as this achieves the expected result of the treatment.
31. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mandavia, Woloszko, and Witt, and further in view of Hayakawa and Robinson.
32. Regarding Claim 10, Mandavia fails to teach upon application of electricity to the at least one wire, the at least one wire causes cutting of a hole in the medium in the cautery plane, wherein, upon completion of the cutting of the hole, tension from the medium holding the retrieval portion against the bias of the biasing element is removed to enable the retrieval portion and a corresponding portion of the medium attached thereto to move to the retracted position such that the portion of the surface being cut is retained by the retrieval portion.
Hayakawa teaches that upon completing of cutting the medium, tension from the medium holding the retrieval portion against the bias of the biasing element is removed (para 0072, “while the thrombi T are crushed by the cutting unit 32”; para 0073, “the balloon 61 is deflated and the thrombus removal device 60 is extracted”; this indicates that there is no tension to the biasing element at this point). By removing the tension from the biasing element, this indicates that the cutting function has been completed and target tissue does not need to be tensioned for the cutting purposes (para 0072). 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 removed the tension from the biasing element upon completion of cutting the medium in order to effectively remove the medium.
33. Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mandavia, and in view of Witt.
34. Regarding Claim 19, Mandavia teaches a cautery tip portion (Fig. 1A, ref nums 106, 103) for a cautery device Fig. 1A, ref num 100) defining a device axis (Fig. 1A, ref num 101), the tip portion comprising:
a. a first electrode (Fig. 1B, ref num 107) and a second electrode (Fig. 1B, ref num 108), wherein the first electrode and the second electrode are spaced apart (see Fig. 1B, ref nums 107 and 108 are spaced apart);
b. at least one wire (Fig. 1B, ref num 104), wherein the at least one wire is in electrical connection with the first electrode and the second electrode (Col. 8, lines 50-53, “The proximal ends PER-1, PER-2 of the electrically conductive rods 107, 108 are mechanically and electrically coupled to the two ends 104a, 104b of the electrode 104”), wherein the at least one wire defines a cautery shape (Col. 5, line 16, “forming a tip for cauterizing tissue when heated” indicates that the central portion has a cautery shape), wherein the cautery shape defines an at least near-continuous perimeter in a cautery plane (Fig. 1B, ref num 104c has a continuous perimeter when connected to ref nums 104a and 104b).
In another embodiment of Mandavia, they teach a retrieval portion (Fig. 4, ref num 410 and 419; Col. 13, lines 56-67 – Col. 14, lines 1-4). However, the embodiments of Mandavia fail to explicitly teach that the retrieval portion is disposed between the first electrode and the second electrode, wherein the retrieval portion extends along and is moveable along a retrieval axis.
Witt teaches a tip portion of analogous art (Fig. 2), wherein the tip portion comprises a first and second electrode (Figs. 1 and 2, ref num 145a and 145b; para 0070, “electrodes 145a,b”) and a retrieval portion (Fig. 1, ref num 165; para 0073, “mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110”). The retrieval portion is positioned between the first and second electrode (see Figs. 2 and 5, ref num 165 is between ref nums 145a, 145b) and is moveable along a retrieval axis (see Fig. 14, ref num 165 is in the extended configuration; para 0074, “the slide switch 130, in a first portion (for example, in a proximal position), may cause the aspiration tube 160 to remain in a first or retracted position… the slide switch 130 in a second position (for example in a distal position), may cause the aspiration tube 160 to extend in a distal direction to a fully extended position”). The retrieval portion provides means to remove unwanted debris and fluid from the target site during treatment (para 0073, “mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110. The liquid mixture may then be removed from the electrosurgical device 100”) and allows control over when the retrieval portion is used to retrieve the debris from the target site (para 0067, 0074). Thus, by providing the retrieval portion, the user may cauterize and remove tissue remnants as needed (para 0033, “incorporating coagulation and aspiration function is desirable”). 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 Mandavia to include a retrieval portion between the first and second electrode, as well as moveable along a retrieval axis, in order to remove unwanted debris from the target site while achieving the same desired result of cauterizing tissue. Also, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the retrieval portion between the first and second electrodes, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
35. Regarding Claim 20, Mandavia fails to teach at least one shuttle connected to the retrieval portion and moveable along the retrieval axis to enable movement of the retrieval portion between a retracted position and an extended position.
Witt teaches at least one shuttle (Figs. 1, 18, and 22, ref num 130) connected to the retrieval portion (para 0074, “the aspiration tube control device may comprise a slide switch 130”) and moveable along the retrieval axis (see Figs. 18 and 22, the movement of ref num 130 is in the same axis as ref num 165/160) to enable movement of the retrieval portion between a retracted position and an extended position (Figs. 18 and 22 show retracted and extended positions of ref num 165/160; para 0078 describes the movement of the retrieval portion relative to the shuttle). This allows control over when the retrieval portion is used to retrieve the debris from the target site (para 0067, 0074). 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 Mandavia to have the retrieval portion moveable between a retracted and extended position, via a shuttle, in order to control the removal of debris.
36. Regarding Claim 21, Mandavia fails to teach when the retrieval portion is in the extended position, a tip of the retrieval portion extends past the cautery plane.
Witt teaches when the retrieval portion is in the extended position (Figs. 14 and 18, ref num 165 is in the extended position), a tip of the retrieval portion extends past the cautery plane (Fig. 14, ref num 165 tip extends past ref nums 145a, 145b, which perform the cautery function, therefore, the tip of 165 extends beyond that plane). This allows control over when the retrieval portion is used to retrieve the debris from the target site when in the extended position (para 0067, 0074). 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 Mandavia to have the retrieval portion extend beyond the cautery plane in order to control the removal of the debris from the target site.
37. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Mandavia and Witt, and further in view of Hayakawa.
38. Regarding Claim 22, Mandavia fails to teach at least one biasing element configured to bias the retrieval portion to the retracted position.
Hayakawa teaches a tip portion of analogous art (Figs. 4A, 4B, 6A, 6B, 12a, and 12B), wherein the tip portion comprises a wire (Fig. 4B, ref num 30) and a retrieval portion (Fig. 6B, ref num 40/42). The retrieval portion may be configured in a retracted and extended position (Figs. 6A and 6B, ref num 40 is in retracted and extended positions, respectively), such that at least one biasing element (Figs. 12A and 12B, ref num 61) is configured to bias the retrieval portion to the retracted position (once the biasing element, i.e. balloon ref num 61, has been deflated and removed, this subsequently causes the retrieval portion, ref num 40/42, to be withdrawn into the retracted position; see para 0073-0074). This biasing element provides the advantage of positioning the target tissue within the cautery/cutting plane in order to perform the expected result of cutting the tissue (para 0031). 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 Mandavia to include a biasing element to bias the retrieval portion to the retracted position in order to cut and capture the target tissue.
39. Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mandavia and Witt, and further in view Robinson.
40. Regarding Claim 23, Mandavia fails to teach the retrieval portion is barbed.
Robinson teaches a retrieval portion is barbed (Fig. 3, ref num 40/42; Col. 5, lines 12-15, “The retractor member is axially movable (arrow 41), is formed of an extended length, and has a barbed tip 42 for piercing and retaining samples during axial travel”). It would have been an obvious matter of design choice to make the different portions retrieval portion 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.
41. Regarding Claim 24, Mandavia fails to teach the retrieval portion is a needle.
Robinson teaches a retrieval portion that is a needle (Fig. 4, ref num 54; Col. 5, line 51, “retractor 54, preferably a spear-form element”). It would have been an obvious matter of design choice to make the different portions retrieval portion 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.
42. Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Mandavia and Witt, and further in view Hayakawa and Robinson.
43. Regarding Claim 25, Mandavia teaches a method of creating a hole using a cautery device (Col. 8, lines 18-25), the method comprising:
a. providing a cautery device (Fig. 1A, ref num 100) defining a device axis (Fig. 1A, ref num 101), comprising a tip portion (Fig. 1A, ref nums 106, 103), the tip portion comprising:
a.1 a first electrode (Fig. 1B, ref num 107) and a second electrode (Fig. 1B, ref num 108) extending through a stabilizer (Fig. 1A, ref nums 107, 108 extend through ref num 102); and,
a.2 at least one wire (Fig. 1B, ref num 104) in electrical connection with the first electrode and the second electrode (Col. 8, lines 50-53, “The proximal ends PER-1, PER-2 of the electrically conductive rods 107, 108 are mechanically and electrically coupled to the two ends 104a, 104b of the electrode 104”), wherein the at least one wire defines a cautery shape (Col. 5, line 16, “forming a tip for cauterizing tissue when heated” indicates that the central portion has a cautery shape), wherein the cautery shape defines an at least near-continuous perimeter in a cautery plane (Fig. 1B, ref num 104c has a continuous perimeter when connected to ref nums 104a and 104b).
While, Mandavia fails to explicitly teach the stabilizer is configured to maintain spacing between the first and second electrodes, it is understood that the channels (Fig. 1d, ref nums 107-C and 108-C) that are part of the stabilizer (Fig. 1D, ref num 102) are configured to maintain the spacing between the first and second electrodes (see Fig. 1D, there is space between 107 and 108). 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 understood that the electrodes of Mandavia maintain space between them in order to produce the same expected result of the invention.
In another embodiment of Mandavia, they teach a retrieval portion (Fig. 4, ref num 410 and 419; Col. 13, lines 56-67 – Col. 14, lines 1-4).
However, the embodiments of Mandavia fail to explicitly teach that (a.3) the retrieval portion is disposed between the first electrode and the second electrode, wherein the retrieval portion extends along and is moveable along a retrieval axis; (a.4) at least one shuttle connected to the retrieval portion and moveable along the retrieval axis to enable movement of the retrieval portion between a retracted position and an extended position; (a.5) at least one biasing element configured to bias the retrieval portion in the retracted position; (b) puncturing a graft with the retrieval portion, such that the graft is in contact with the at least one wire, wherein the retrieval portion provides tension on the graft; cutting the graft in the cautery shape, wherein the first electrode and the second electrode are configured to heat the at least one wire to a temperature, wherein the temperature is configured to cut the graft; and retaining a cautery shaped portion of the graft via the retrieval portion after the graft is cut.
Witt teaches a tip portion of analogous art (Fig. 2), wherein the tip portion comprises a first and second electrode (Figs. 1 and 2, ref num 145a and 145b; para 0070, “electrodes 145a,b”) and a retrieval portion (Fig. 1, ref num 165; para 0073, “mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110”). The retrieval portion is positioned between the first and second electrode (see Figs. 2 and 5, ref num 165 is between ref nums 145a, 145b) and is moveable along a retrieval axis (see Fig. 14, ref num 165 is in the extended configuration; para 0074, “the slide switch 130, in a first portion (for example, in a proximal position), may cause the aspiration tube 160 to remain in a first or retracted position… the slide switch 130 in a second position (for example in a distal position), may cause the aspiration tube 160 to extend in a distal direction to a fully extended position”). The retrieval portion provides means to remove unwanted debris and fluid from the target site during treatment (para 0073, “mixture generated at the surgical site to flow from the fluid aspiration port 165 to the fluid evacuation port 110. The liquid mixture may then be removed from the electrosurgical device 100”) and allows control over when the retrieval portion is used to retrieve the debris from the target site (para 0067, 0074). Thus, by providing the retrieval portion, the user may cauterize and remove tissue remnants as needed (para 0033, “incorporating coagulation and aspiration function is desirable”). 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 Mandavia to include a retrieval portion between the first and second electrode, as well as moveable along a retrieval axis, in order to remove unwanted debris from the target site while achieving the same desired result of cauterizing tissue. Also, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the retrieval portion between the first and second electrodes, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Witt also teaches when the retrieval portion is in the extended position (Figs. 14 and 18, ref num 165 is in the extended position), a tip of the retrieval portion extends past the cautery plane (Fig. 14, ref num 165 tip extends past ref nums 145a, 145b, which perform the cautery function, therefore, the tip of 165 extends beyond that plane). This allows control over when the retrieval portion is used to retrieve the debris from the target site when in the extended position (para 0067, 0074). 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 Mandavia to have the retrieval portion extend beyond the cautery plane in order to control the removal of the debris from the target site.
Hayakawa teaches a tip portion of analogous art (Figs. 4A, 4B, 6A, 6B, 12a, and 12B), wherein the tip portion comprises a wire (Fig. 4B, ref num 30) and a retrieval portion (Fig. 6B, ref num 40/42). The retrieval portion may be configured in a retracted and extended position (Figs. 6A and 6B, ref num 40 is in retracted and extended positions, respectively), such that at least one biasing element (Figs. 12A and 12B, ref num 61) is configured to bias the retrieval portion to the retracted position (once the biasing element, i.e. balloon ref num 61, has been deflated and removed, this subsequently causes the retrieval portion, ref num 40/42, to be withdrawn into the retracted position; see para 0073-0074). This biasing element provides the advantage of positioning the target tissue within the cautery/cutting plane in order to perform the expected result of cutting the tissue (para 0031). 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 Mandavia to include a biasing element to bias the retrieval portion to the retracted position in order to cut and capture the target tissue.
Robinson teaches a tip portion of analogous art (Fig. 4), wherein the tip portion comprises a wire that defines a cautery shape (Fig. 4, ref num 64; Col. 5, lines 61-62, “a wire-form cutting loop 64”) and a retrieval portion (Fig. 4, ref num 54). The retrieval portion punctures a graft (Fig. 4a, ref num 54 punctures 18), such that the graft is in contact with the at least one wire (Fig. 4a, ref num 18 is in contact with ref num 64), wherein the retrieval portion provides tension on the graft (Col. 1, lines 64-66, “The retractor is a spear-form element adapted to pierce tissue and has a retaining barb on its distal end”; the retaining barb indicates tension on the graft); cutting the graft in the cautery shape, wherein current is used to heat the at least one wire to a temperature, wherein the temperature is configured to cut the graft (Col. 7, lines 19-20, “the cutting loop may also be heated e.g., by electric current”; see Figs. 4c and 4e, ref num 64 cuts the graft, ref num 18); and retaining a cautery shaped portion of the graft via the retrieval portion after the graft is cut (see Fig. 4e, the retrieval portion, ref num 54, and medium, ref num 18 are in retracted position and the medium is retained by ref num 54). his removes the medium from the target site as needed by the procedure (Col. 6, lines 8-29). 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 Mandavia to have the retrieval portion retain the graft upon cutting the graft, in order to remove it from the target site.
Conclusion
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794