DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
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 application, Application No. 18/072,596, fails to 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. Specifically, the parent application does not describe the claimed “a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, and a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath”.
Thus, the effective filing date of all pending claims in the present application is 9/9/2024.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-9, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roxhed et al. (US Publication No. 2023/0099335 A1), further in view of Poulsen et al. (US Patent No. 12,575,853 B2) and Teague et al. (US Patent No. 9,675,369 B2).
Regarding claim 1, Roxhed et al. discloses a device for detaching cells or tissue from a cavity in a subject, the device comprising:
an elongated member extending from the handle and arranged to be moved within a lumen of a needle or a catheter (see Figure 2 and [0009] – “This objected is achieved in a first aspect of the present disclosure in which there is provided a device for detaching cells or tissue from a cavity in a subject, the device comprising: an elongated member arranged to be moved within a lumen of a needle or a catheter; and at least one flexible member arranged at a distal end of the elongated member, wherein the flexible member is configured to be brought between a first, constrained configuration within the lumen of the needle or catheter, and a second, expanded configuration outside said lumen, wherein the flexible member in the second, expanded configuration is configured to conform to an inner geometry of a cavity in which the device is inserted”);
a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle or catheter and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen (see Figure 2 and [0009] – “This objected is achieved in a first aspect of the present disclosure in which there is provided a device for detaching cells or tissue from a cavity in a subject, the device comprising: an elongated member arranged to be moved within a lumen of a needle or a catheter; and at least one flexible member arranged at a distal end of the elongated member, wherein the flexible member is configured to be brought between a first, constrained configuration within the lumen of the needle or catheter, and a second, expanded configuration outside said lumen, wherein the flexible member in the second, expanded configuration is configured to conform to an inner geometry of a cavity in which the device is inserted”);
a tubular sheath extending from the handle, arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter (see [0018] – “In one embodiment, the device further comprises a tubular sheath arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter”).
It is noted Roxhed et al. does not specifically teach a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath.
However, Poulsen et al. teaches a handle (5), a first actuator (15A) associated with the handle and coupled to a proximal end of the elongated member (40b) such that movement of the first actuator causes translation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”), and a second actuator (15B) associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”). Teague et al. teaches a handle, a second actuator (32, 124) associated with the handle and coupled to a proximal end of the elongated member (18, 110) such that movement of the second actuator causes rotation of the elongated member (see Figures 1, 4, 6, and 9 and col. 8, lines 14-18 – “When the operator turns the rotation knob 32, the gear system rotates the pinch vise 27, and the torque of the pinch vise 27 turns the elongate member 18 about its longitudinal axis. When the elongate member 18 rotates about its longitudinal axis, the end effector 16, attached to the distal end of the elongate member 18, also rotates about its longitudinal axis” and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”), and a third actuator (28, 114) associated with the handle and coupled to a proximal end of the tubular sheath (20, 118) such that movement of the third actuator causes translation of the tubular sheath (see Figures 1, 4, and 9 and col. 7, lines 9-18 – “In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in FIG. 4. This will cause the end effector 16 to collapse into the sheath 20. By turning the top of the thumb wheel 28 toward the distal end of the handle 24, or counter-clockwise in FIG. 4, the operator moves the rack gear 30 and sheath 20 toward the proximal end of the device 10, exposing the end effector 16 for expansion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Roxhed et al. to include a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath, as disclosed in Poulsen et al. and Teague et al., so as to provide improved accuracy in positioning the device at the target site (see Poulsen et al.: col. 5, lines 1-2) and provide improved capabilities for sustained capture, controlled release, and limited patient tissue trauma while allowing operation of the device without the need for two hands or an assistant (see Teague et al.: col. 2, lines 33-37).
Regarding claim 4, Teague et al. teaches the second actuator comprises a knob rotatably supported on the handle (see Figure 9 and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”).
Regarding claim 5, Teague et al. teaches the knob is connected to a proximal end of the elongated member (see Figure 9 and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”).
Regarding claim 6, Teague et al. teaches the third actuator comprises a wheel rotatably supported on the handle (see Figures 1, 4, and 9 and col. 7, lines 9-18 – “In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in FIG. 4. This will cause the end effector 16 to collapse into the sheath 20. By turning the top of the thumb wheel 28 toward the distal end of the handle 24, or counter-clockwise in FIG. 4, the operator moves the rack gear 30 and sheath 20 toward the proximal end of the device 10, exposing the end effector 16 for expansion”).
Regarding claim 7, Teague et al. teaches the proximal end of the tubular sheath is connected to a tubular holder (30, 120) comprising an external thread (31, 122) configured to engage with a corresponding internal thread (29, 116) of the wheel (see Figures 4 and 9 and col. 7, lines 19-25 – “The rack gear 30 includes a long element or rack that lies within the handle 12. The long element of the rack gear 30 is connected to the sheath 20 and is configured to move along the longitudinal axis L-L of the handle 12. Teeth 29 on the edges of thumb wheel 28 engage or interfit with teeth 31 on the long element of the rack gear 30, thereby causing movement of the rack gear when the thumb wheel 28 turns”).
Regarding claim 8, Teague et al. teaches the handle comprises one or more shield members (36) arranged adjacent to the wheel to limit access to the wheel (see Figures 1 and 7 and col. 6, lines 53-65 – “The handle 12 includes a locking mechanism to lock the thumb wheel 28 in place when not depressed. As shown in FIG. 7, in this embodiment, the locking mechanism includes a locking piece 36 and an inner gear 38. Inner gear 38 attached to the thumb wheel 28 within the handle 12 is positioned under locking piece 36. The locking piece 36 attaches to or is otherwise an integral portion of the body of the handle 12. When the thumb wheel 28 is not depressed, teeth on the top of the outer edge of the inner gear 38 engage teeth or any textured surface on the inside of the locking piece 36 where it meets the inner gear 38 to hold the inner gear 38 in place. In turn, the inner gear 38 holds the thumb gear 28 in place and keeps it from rotating”).
Regarding claim 9, Roxhed et al. teaches the flexible member is arranged to form at least one loop in the expanded configuration (see [0012] – “In one embodiment, the flexible member is arranged to form at least one loop in the expanded configuration. The loop shape allows the flexible member to conform to the desired shape of the inner geometry of the cavity in a simple manner. Additionally, the loop shape reduces the distance required to advance the elongated member before reaching the fully deployed expanded configuration of the flexible member”).
Regarding claim 11, Roxhed et al. teaches the flexible member is made from a shape-memory alloy (see [0011] – “In one embodiment, the flexible member is a superelastic wire, preferably made of a shape-memory alloy. Superelasticity, especially shape-memory alloys such as nickel titanium, allows the flexible member to adopt the desired shape of the inner geometry of the cavity, e.g. a cyst, when the device is inserted therein”).
Regarding claim 12, Roxhed et al. discloses a method for detaching cells or tissue from a cavity in a subject, the method comprising:
providing a device that includes:
an elongated member extending from the handle and arranged to be moved within a lumen of a needle or a catheter (see Figure 2 and [0009] – “This objected is achieved in a first aspect of the present disclosure in which there is provided a device for detaching cells or tissue from a cavity in a subject, the device comprising: an elongated member arranged to be moved within a lumen of a needle or a catheter; and at least one flexible member arranged at a distal end of the elongated member, wherein the flexible member is configured to be brought between a first, constrained configuration within the lumen of the needle or catheter, and a second, expanded configuration outside said lumen, wherein the flexible member in the second, expanded configuration is configured to conform to an inner geometry of a cavity in which the device is inserted”);
a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle or catheter and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen (see Figure 2 and [0009] – “This objected is achieved in a first aspect of the present disclosure in which there is provided a device for detaching cells or tissue from a cavity in a subject, the device comprising: an elongated member arranged to be moved within a lumen of a needle or a catheter; and at least one flexible member arranged at a distal end of the elongated member, wherein the flexible member is configured to be brought between a first, constrained configuration within the lumen of the needle or catheter, and a second, expanded configuration outside said lumen, wherein the flexible member in the second, expanded configuration is configured to conform to an inner geometry of a cavity in which the device is inserted”);
a tubular sheath extending from the handle, arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter (see [0018] – “In one embodiment, the device further comprises a tubular sheath arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter”);
introducing the device into the cavity in the subject through the lumen of a hollow needle (see [0024] – “advancing the elongated member through the lumen of the needle such that the flexible member protrudes from a distal tip of the needle and assumes the second, expanded configuration inside the cavity and comes into contact with an inner wall of the cavity”);
advancing the elongated member through the lumen of the needle in a distal direction such that the flexible member protrudes from a distal tip of the needle and assumes the second, expanded configuration inside the cavity and comes into contact with an inner wall of the cavity (see [0024] – “advancing the elongated member through the lumen of the needle such that the flexible member protrudes from a distal tip of the needle and assumes the second, expanded configuration inside the cavity and comes into contact with an inner wall of the cavity”);
advancing the tubular sheath through the needle such that a distal end of the tubular sheath exits the distal tip of the needle and contacts the expanded flexible member (see [0030] – “before the step of rotating the elongated member, advancing the tubular sheath through the needle such that a distal end of the tubular sheath exits the distal tip of the needle and contacts the expanded flexible member”);
rotating the elongated member such that the expanded flexible member scrapes the inner wall of the cavity (see [0025] – “rotating the elongated member such that the expanded flexible member scrapes the inner wall of the cavity”);
retracting the elongated member into the lumen of the needle such that the flexible member is brought to the first, constrained configuration and re-enters the distal tip of the needle (see [0026] – “retracting the elongated member into the lumen of the needle such that the flexible member is brought to the first, constrained configuration and re-enters the distal tip of the needle”);
retracting the tubular sheath into the needle (see [0031] – “after the step of retracting the elongated member, retracting the tubular sheath into the needle”);
aspirating fluid from the cavity through the lumen of the needle (see [0027] – “aspirating fluid from the cavity through the lumen of the needle”); and
retracting the needle from the cavity (see [0028] – “retracting the needle from the cavity”).
It is noted Roxhed et al. does not specifically teach a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath.
However, Poulsen et al. teaches a handle (5), a first actuator (15A) associated with the handle and coupled to a proximal end of the elongated member (40b) such that movement of the first actuator causes translation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”), and a second actuator (15B) associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”). Teague et al. teaches a handle, a second actuator (32, 124) associated with the handle and coupled to a proximal end of the elongated member (18, 110) such that movement of the second actuator causes rotation of the elongated member (see Figures 1, 4, 6, and 9 and col. 8, lines 14-18 – “When the operator turns the rotation knob 32, the gear system rotates the pinch vise 27, and the torque of the pinch vise 27 turns the elongate member 18 about its longitudinal axis. When the elongate member 18 rotates about its longitudinal axis, the end effector 16, attached to the distal end of the elongate member 18, also rotates about its longitudinal axis” and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”), and a third actuator (28, 114) associated with the handle and coupled to a proximal end of the tubular sheath (20, 118) such that movement of the third actuator causes translation of the tubular sheath (see Figures 1, 4, and 9 and col. 7, lines 9-18 – “In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in FIG. 4. This will cause the end effector 16 to collapse into the sheath 20. By turning the top of the thumb wheel 28 toward the distal end of the handle 24, or counter-clockwise in FIG. 4, the operator moves the rack gear 30 and sheath 20 toward the proximal end of the device 10, exposing the end effector 16 for expansion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Roxhed et al. to include a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath, as disclosed in Poulsen et al. and Teague et al., so as to provide improved accuracy in positioning the device at the target site (see Poulsen et al.: col. 5, lines 1-2) and provide improved capabilities for sustained capture, controlled release, and limited patient tissue trauma while allowing operation of the device without the need for two hands or an assistant (see Teague et al.: col. 2, lines 33-37).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roxhed et al., Poulsen et al., and Teague et al., further in view of Fojtik et al. (US Publication No. 2018/0153572 A1).
Regarding claims 2-3, it is noted none of Roxhed et al., Poulsen et al., or Teague et al. specifically teach the first actuator comprises a cylindrical gear rotatably supported on the handle, wherein the proximal end of the elongated member is connected to a cylindrical holder comprising an external rack configured to engage with the gear. However, Fojtik et al. teaches the first actuator comprises a cylindrical gear (92) rotatably supported on the handle, wherein the proximal end (23) of the elongated member (21) is connected to a cylindrical holder (96) comprising an external rack configured to engage with the gear (see [0046] – “In some embodiments, teeth 94 of each gear 92 may engage corresponding, complementarily configured teeth 98 of an element 97 of a second runner 96. The second end 23 of the elongated element 21 of the snare 20 (FIGS. 1 and 1A) may be secured to the second runner 96… As each gear 92 rotates, it may cause the second runner 96 and the second end 23 of the elongated element 21 of the snare 20 to move backwards, or proximally. Thus, pressing the external element 82 of the trigger 81 may induce movement of the snare 20 in a first direction D1”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Roxhed et al., Poulsen et al., and Teague et al. to include the first actuator comprises a cylindrical gear rotatably supported on the handle, wherein the proximal end of the elongated member is connected to a cylindrical holder comprising an external rack configured to engage with the gear, as disclosed in Fojtik et al., so as to enable advancement of the snare 20 within the body of a subject, positioning of the snare over an object with the subject's body, engagement of an object with the body of the subject, and/or cutting of an object within the body of the subject (see Fojtik et al.: [0048]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roxhed et al., Poulsen et al., and Teague et al., further in view of Lampropoulos et al. (US Patent No. 8,974,470 B2).
Regarding claim 10, it is noted none of Roxhed et al., Poulsen et al., or Teague et al. specifically teach the flexible member forms a primary loop which in the expanded configuration extends laterally perpendicular to an axis of the elongated member and secondary loop distal of the primary loop, wherein the secondary loop is smaller than the primary loop. However, Lampropoulos et al. teaches the flexible member forms a primary loop (250) which in the expanded configuration extends laterally perpendicular to an axis of the elongated member and secondary loop distal (230, 240) of the primary loop (see col. 4, lines 59-62 – “Additionally, each of the snare loops 230, 240, 250 are disposed substantially perpendicular to the longitudinal axis of the elongate shaft 210 when the snare loops 230, 240, 250 are in an unconstrained state”), wherein the secondary loop is smaller than the primary loop (see col. 4, lines 49-52 – “In other embodiments, this order may be modified, for example, the smallest loop may be in the distal most position and/or the loops may not be arranged in sequential order by size”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Roxhed et al., Poulsen et al., and Teague et al. to include the flexible member forms a primary loop which in the expanded configuration extends laterally perpendicular to an axis of the elongated member and secondary loop distal of the primary loop, wherein the secondary loop is smaller than the primary loop, as disclosed in Lampropoulos et al., so as to provide loops of differing sizes and shapes, which may allow a practitioner flexibility during the procedure to use alternatively sized or shaped snare loops without removing the entire snare and inserting a second separate snare (see Lampropoulos et al.: col. 3, lines 58-62).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-9, and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 15 of U.S. Patent No. 12,082,790 B2 in view of Poulsen et al. and Teague et al.
Regarding claim 1, the reference patent teaches an elongated member extending from the handle and arranged to be moved within a lumen of a needle or a catheter (see claim 1 – “an elongated member movably arranged inside a lumen of the needle”);
a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle or catheter and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen (see claim 1 – “a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle and, following advancement of the elongated member in the needle, the flexible member has a second, expanded configuration outside said lumen”);
a tubular sheath extending from the handle, arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter (see claim 1 – “a tubular sheath arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle so that a distal end of the tubular sheath contacts the loop of the expanded configuration outside the lumen of the needle”).
It is noted the reference patent does not specifically teach a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath.
However, Poulsen et al. teaches a handle (5), a first actuator (15A) associated with the handle and coupled to a proximal end of the elongated member (40b) such that movement of the first actuator causes translation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”), and a second actuator (15B) associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”). Teague et al. teaches a handle, a second actuator (32, 124) associated with the handle and coupled to a proximal end of the elongated member (18, 110) such that movement of the second actuator causes rotation of the elongated member (see Figures 1, 4, 6, and 9 and col. 8, lines 14-18 – “When the operator turns the rotation knob 32, the gear system rotates the pinch vise 27, and the torque of the pinch vise 27 turns the elongate member 18 about its longitudinal axis. When the elongate member 18 rotates about its longitudinal axis, the end effector 16, attached to the distal end of the elongate member 18, also rotates about its longitudinal axis” and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”), and a third actuator (28, 114) associated with the handle and coupled to a proximal end of the tubular sheath (20, 118) such that movement of the third actuator causes translation of the tubular sheath (see Figures 1, 4, and 9 and col. 7, lines 9-18 – “In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in FIG. 4. This will cause the end effector 16 to collapse into the sheath 20. By turning the top of the thumb wheel 28 toward the distal end of the handle 24, or counter-clockwise in FIG. 4, the operator moves the rack gear 30 and sheath 20 toward the proximal end of the device 10, exposing the end effector 16 for expansion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of reference patent to include a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath, as disclosed in Poulsen et al. and Teague et al., so as to provide improved accuracy in positioning the device at the target site (see Poulsen et al.: col. 5, lines 1-2) and provide improved capabilities for sustained capture, controlled release, and limited patient tissue trauma while allowing operation of the device without the need for two hands or an assistant (see Teague et al.: col. 2, lines 33-37).
Regarding claim 4, Teague et al. teaches the second actuator comprises a knob rotatably supported on the handle (see Figure 9 and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”).
Regarding claim 5, Teague et al. teaches the knob is connected to a proximal end of the elongated member (see Figure 9 and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”).
Regarding claim 6, Teague et al. teaches the third actuator comprises a wheel rotatably supported on the handle (see Figures 1, 4, and 9 and col. 7, lines 9-18 – “In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in FIG. 4. This will cause the end effector 16 to collapse into the sheath 20. By turning the top of the thumb wheel 28 toward the distal end of the handle 24, or counter-clockwise in FIG. 4, the operator moves the rack gear 30 and sheath 20 toward the proximal end of the device 10, exposing the end effector 16 for expansion”).
Regarding claim 7, Teague et al. teaches the proximal end of the tubular sheath is connected to a tubular holder (30, 120) comprising an external thread (31, 122) configured to engage with a corresponding internal thread (29, 116) of the wheel (see Figures 4 and 9 and col. 7, lines 19-25 – “The rack gear 30 includes a long element or rack that lies within the handle 12. The long element of the rack gear 30 is connected to the sheath 20 and is configured to move along the longitudinal axis L-L of the handle 12. Teeth 29 on the edges of thumb wheel 28 engage or interfit with teeth 31 on the long element of the rack gear 30, thereby causing movement of the rack gear when the thumb wheel 28 turns”).
Regarding claim 8, Teague et al. teaches the handle comprises one or more shield members (36) arranged adjacent to the wheel to limit access to the wheel (see Figures 1 and 7 and col. 6, lines 53-65 – “The handle 12 includes a locking mechanism to lock the thumb wheel 28 in place when not depressed. As shown in FIG. 7, in this embodiment, the locking mechanism includes a locking piece 36 and an inner gear 38. Inner gear 38 attached to the thumb wheel 28 within the handle 12 is positioned under locking piece 36. The locking piece 36 attaches to or is otherwise an integral portion of the body of the handle 12. When the thumb wheel 28 is not depressed, teeth on the top of the outer edge of the inner gear 38 engage teeth or any textured surface on the inside of the locking piece 36 where it meets the inner gear 38 to hold the inner gear 38 in place. In turn, the inner gear 38 holds the thumb gear 28 in place and keeps it from rotating”).
Regarding claim 9, the reference patent teaches the flexible member is arranged to form at least one loop in the expanded configuration (see claim 1 – “the flexible member is arranged to form a loop in the expanded configuration”).
Regarding claim 11, the reference patent teaches the flexible member is made from a shape-memory alloy (see claim 3 – “the flexible member is made of a shape-memory alloy”).
Regarding claim 12, the reference patent teaches a method for detaching cells or tissue from a cavity in a subject, the method comprising:
providing a device that includes:
an elongated member extending from the handle and arranged to be moved within a lumen of a needle or a catheter (see claim 15 – “an elongated member arranged to be moved within a lumen of the needle”);
a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle or catheter and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen (see claim 15 – “a flexible member arranged at a distal end of the elongated member, wherein the flexible member has a first, constrained configuration within the lumen of the needle and, following advancement of the elongated member in the needle or catheter, the flexible member has a second, expanded configuration outside said lumen”);
a tubular sheath extending from the handle, arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle or catheter (see claim 15 – “a tubular sheath arranged outside the elongated member and configured to be moved along the elongated member inside the lumen of the needle so that a distal end of the tubular sheath contacts the loop of the expanded configuration outside the lumen of the needle”);
introducing the device into the cavity in the subject through the lumen of a hollow needle (see claim 15 – “advancing the elongated member through the lumen of the needle in a distal direction such that the flexible member protrudes from a distal tip of the needle and expands to the expanded configuration”);
advancing the elongated member through the lumen of the needle in a distal direction such that the flexible member protrudes from a distal tip of the needle and assumes the second, expanded configuration inside the cavity and comes into contact with an inner wall of the cavity (see claim 15 – “advancing the elongated member through the lumen of the needle in a distal direction such that the flexible member protrudes from a distal tip of the needle and expands to the expanded configuration”);
advancing the tubular sheath through the needle such that a distal end of the tubular sheath exits the distal tip of the needle and contacts the expanded flexible member (see claim 15 – “advancing the tubular sheath through the needle such that the distal end of the tubular sheath exits the distal tip of the needle and contacts the loop of the expanded flexible member”);
rotating the elongated member such that the expanded flexible member scrapes the inner wall of the cavity (see claim 15 – “rotating the elongated member such that the loop of the expanded flexible member scrapes the inner wall of the cavity”);
retracting the elongated member into the lumen of the needle such that the flexible member is brought to the first, constrained configuration and re-enters the distal tip of the needle (see claim 15 – “retracting the elongated member into the lumen of the needle such that the flexible member is brought to the first, constrained configuration and re-enters the distal tip of the needle”);
retracting the tubular sheath into the needle (see claim 15 – “retracting the tubular sheath into the needle”);
aspirating fluid from the cavity through the lumen of the needle (see claim 15 – “aspirating fluid from the cavity through the lumen of the needle”); and
retracting the needle from the cavity (see claim 15 – “retracting the needle from the cavity”).
It is noted the reference patent does not specifically teach a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath.
However, Poulsen et al. teaches a handle (5), a first actuator (15A) associated with the handle and coupled to a proximal end of the elongated member (40b) such that movement of the first actuator causes translation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”), and a second actuator (15B) associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member (see Figures 1-2 and col. 2, lines 49-55 – “Movement of the actuation button within the cutout along the longitudinal axis moves the snare loop or other snare capture structure along the longitudinal axis (e.g. to deploy the snare loop from the sheath and/or retract the snare capture structure into the sheath), and rotation of the actuation button rotates the snare capture structure (e.g. after it is deployed from the sheath)” and col. 6, lines 4-8 – “As shown in FIGS. 1 and 2, the actuation button 15 may include a sliding portion 15A to control the longitudinal movement of the medical device 40 and a rotating portion 15B to control rotational movement associated with the medical device 40”). Teague et al. teaches a handle, a second actuator (32, 124) associated with the handle and coupled to a proximal end of the elongated member (18, 110) such that movement of the second actuator causes rotation of the elongated member (see Figures 1, 4, 6, and 9 and col. 8, lines 14-18 – “When the operator turns the rotation knob 32, the gear system rotates the pinch vise 27, and the torque of the pinch vise 27 turns the elongate member 18 about its longitudinal axis. When the elongate member 18 rotates about its longitudinal axis, the end effector 16, attached to the distal end of the elongate member 18, also rotates about its longitudinal axis” and col. 10, lines 18-24 – “The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction”), and a third actuator (28, 114) associated with the handle and coupled to a proximal end of the tubular sheath (20, 118) such that movement of the third actuator causes translation of the tubular sheath (see Figures 1, 4, and 9 and col. 7, lines 9-18 – “In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in FIG. 4. This will cause the end effector 16 to collapse into the sheath 20. By turning the top of the thumb wheel 28 toward the distal end of the handle 24, or counter-clockwise in FIG. 4, the operator moves the rack gear 30 and sheath 20 toward the proximal end of the device 10, exposing the end effector 16 for expansion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the reference patent to include a handle, a first actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the first actuator causes translation of the elongated member, a second actuator associated with the handle and coupled to a proximal end of the elongated member such that movement of the second actuator causes rotation of the elongated member, or a third actuator associated with the handle and coupled to a proximal end of the tubular sheath such that movement of the third actuator causes translation of the tubular sheath, as disclosed in Poulsen et al. and Teague et al., so as to provide improved accuracy in positioning the device at the target site (see Poulsen et al.: col. 5, lines 1-2) and provide improved capabilities for sustained capture, controlled release, and limited patient tissue trauma while allowing operation of the device without the need for two hands or an assistant (see Teague et al.: col. 2, lines 33-37).
Claims 2-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 15 of U.S. Patent No. 12,082,790 B2 in view of Poulsen et al., Teague et al., and Fojtik et al.
Regarding claims 2-3, it is noted none of the reference patent, Poulsen et al., or Teague et al. specifically teach the first actuator comprises a cylindrical gear rotatably supported on the handle, wherein the proximal end of the elongated member is connected to a cylindrical holder comprising an external rack configured to engage with the gear. However, Fojtik et al. teaches the first actuator comprises a cylindrical gear (92) rotatably supported on the handle, wherein the proximal end (23) of the elongated member (21) is connected to a cylindrical holder (96) comprising an external rack configured to engage with the gear (see [0046] – “In some embodiments, teeth 94 of each gear 92 may engage corresponding, complementarily configured teeth 98 of an element 97 of a second runner 96. The second end 23 of the elongated element 21 of the snare 20 (FIGS. 1 and 1A) may be secured to the second runner 96… As each gear 92 rotates, it may cause the second runner 96 and the second end 23 of the elongated element 21 of the snare 20 to move backwards, or proximally. Thus, pressing the external element 82 of the trigger 81 may induce movement of the snare 20 in a first direction D1”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the reference patent, Poulsen et al., and Teague et al. to include the first actuator comprises a cylindrical gear rotatably supported on the handle, wherein the proximal end of the elongated member is connected to a cylindrical holder comprising an external rack configured to engage with the gear, as disclosed in Fojtik et al., so as to enable advancement of the snare 20 within the body of a subject, positioning of the snare over an object with the subject's body, engagement of an object with the body of the subject, and/or cutting of an object within the body of the subject (see Fojtik et al.: [0048]).
Claims 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 15 of U.S. Patent No. 12,082,790 B2 in view of Poulsen et al., Teague et al., and Lampropoulos et al.
Regarding claim 10, it is noted none of the reference patent, Poulsen et al., or Teague et al. specifically teach the flexible member forms a primary loop which in the expanded configuration extends laterally perpendicular to an axis of the elongated member and secondary loop distal of the primary loop, wherein the secondary loop is smaller than the primary loop. However, Lampropoulos et al. teaches the flexible member forms a primary loop (250) which in the expanded configuration extends laterally perpendicular to an axis of the elongated member and secondary loop distal (230, 240) of the primary loop (see col. 4, lines 59-62 – “Additionally, each of the snare loops 230, 240, 250 are disposed substantially perpendicular to the longitudinal axis of the elongate shaft 210 when the snare loops 230, 240, 250 are in an unconstrained state”), wherein the secondary loop is smaller than the primary loop (see col. 4, lines 49-52 – “In other embodiments, this order may be modified, for example, the smallest loop may be in the distal most position and/or the loops may not be arranged in sequential order by size”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the reference patent, Poulsen et al., and Teague et al. to include the flexible member forms a primary loop which in the expanded configuration extends laterally perpendicular to an axis of the elongated member and secondary loop distal of the primary loop, wherein the secondary loop is smaller than the primary loop, as disclosed in Lampropoulos et al., so as to provide loops of differing sizes and shapes, which may allow a practitioner flexibility during the procedure to use alternatively sized or shaped snare loops without removing the entire snare and inserting a second separate snare (see Lampropoulos et al.: col. 3, lines 58-62).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
Prosecution Insights