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 .
Election/Restrictions
Claims 1-10 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 29th, 2025.
Applicant’s election without traverse of Group II (Claims 11-17) in the reply filed on December 29th, 2025 is acknowledged.
Amendment Entered
In response to the amendment filed on December 29th, 2025, amended claim 17 is entered. Claims 1-10 and 18-20 are withdrawn from consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites “wherein the core is configured for receiving a distal portion the cable and wire of the catheter portion” in lines 1-2. It is unclear as to exactly what this limitation entails, as there seems to be a grammatical error present or a word missing. Examiner will interpret this limitation as “wherein the core is configured for receiving a distal portion of the cable and wire of the catheter portion”.
Claim 14 recites “the engagement mechanism” in line 2. It is unclear as to whether this “engagement mechanism” is referring to the previously introduced “catheter engagement mechanism” from Claim 11, “device engagement mechanism” from Claim 11, or “handle engagement mechanism” from Claim 11. Clarification is requested.
Claim 15 recites “the engagement mechanism” in line 2. Similar to Claim 14, it is unclear as to whether this “engagement mechanism” is referring to the previously introduced “catheter engagement mechanism” from Claim 11, “device engagement mechanism” from Claim 11, or “handle engagement mechanism” from Claim 11. Clarification is requested.
Claim 16 recites the limitation "the handle" in line 1. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear as to whether “the handle” is referring to the previously introduced “handle portion” from Claim 11, or a separate element.
Claim 17 recites the limitation "the handle" in line 1. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear as to whether “the handle” is referring to the previously introduced “handle portion” from Claim 11, or a separate element.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11-13 are rejected under 35 U.S.C. 102 as being anticipated by Palmer et al (U.S. Patent No. 5,782,748).
Regarding Claim 11, Palmer discloses a decoupling delivery system for delivering a medical device (endoscopic surgical instrument; Abstract), the delivery
system comprising:
a proximal end (a proximal handle assembly 12 (FIG. 1); Column 5 Lines 19-20) and a distal end (a detachable distal jaw (end effector) assembly 14 (FIG. 2); Column 5 Lines 20-21);
a handle portion provided at the proximal end (a proximal handle assembly 12; Column 5 Lines 19-43; Figure 1), the handle portion including:
a core (body portion of proximal handle assembly 12; Column 5 Lines 20-42; Figure 1);
an engagement control (displaceable spool 18) (The displaceable spool 18 is provided with a cross member 30 which passes through the slot 28 in the central shaft 16…relative movement of the shaft 16 and spool 18 results in movement of the pull wire 22 relative to the coil 20; Column 5 Lines 30-38; Figure 1); and
a catheter engagement mechanism (first coupling device 40; Column 5 Line 66 – Column 6 Line 21; Figures 1, 3, and 4);
a device engagement mechanism (distal jaw assembly 14) provided at the distal end of the system for engaging the medical device (the distal jaw assembly 14 includes a pair of jaws 52, 54, a clevis 56; Column 5 Lines 44-65; Figure 2), the device engagement mechanism comprising a pair of prongs that are biased toward an open position (The jaw assembly 152 includes a pair of opposed jaw cups 152a, 152b…a resilient, preferably narrow, arm 152e, 152f extends proximally from each jaw cup 152a, 152b…the narrow resilient arms 152e, 152f are biased apart from each other, thereby urging the jaw cups 152a, 152b apart; Column 7 Lines 19-26; Figure 13); and
a catheter portion extending between the handle portion and the device engagement mechanism (a relatively short flexible coil 58 (preferably approximately eight inches or less), and a relatively short flexible pull wire 60 which extends through the coil 58…the proximal end 58b of the coil 58 and the proximal end 60b of the pull wire 60 are provided with a second coupling device 70; Column 5 Lines 45-62), wherein the catheter portion comprises: a handle engagement mechanism (a second coupling device 70…is mateable with the first coupling device 40 mentioned above; Column 5 Lines 62-65; Figures 7-12);
a wire coupleable to the device engagement mechanism (flexible pull wire 60; Column 5 Lines 44-65; Figures 1-2); and a cable, wherein the wire extends within the cable (a relatively short flexible pull wire 60 which extends through the coil 58; Column 5 Lines 44-65; Figures 1-2);
wherein the handle portion is removably coupleable from the catheter portion by engaging and disengaging the catheter engagement mechanism with the handle engagement mechanism (those skilled in the art may readily appreciate how the first coupling device 40 is coupled with the second coupling device 70 as shown in FIGS. 7 through 12…uncoupling the couplers 40 and 70 is effected by reversing the steps described, i.e. by pressing the couplers together, rotating them to move the protrusion out of the locking seat, separating the couplers 42, 72 and lifting the ball coupler 74 out of the socket coupler 44; Column 6 Lines 37-65) and wherein the medical device remains engaged by the device engagement mechanism when the handle portion is decoupled from the delivery system (it will be appreciated that movement of the coil 58 relative to the pull wire 60 results in opening or closing of the jaws 52, 54; Column 5 Lines 58-60; Examiner’s Note: A medical device may remain engaged by the distal jaw assembly regardless of whether the handle portion is coupled or not, as the opening and closing of the jaws is not contingent upon the coupling process);
wherein actuation of the handle portion advances or retracts the wire longitudinally within the cable (relative movement of the shaft 16 and spool 18 results in movement of the pull wire 22 relative to the coil 20; Column 5 Lines 37-39) and wherein such actuation operates to open and close the device engagement mechanism (movement of the coil 58 relative to the pull wire 60 results in opening or closing of the jaws 52, 54; Column 5 Lines 58-60).
Regarding Claim 12, Palmer discloses wherein the catheter engagement mechanism and the handle engagement mechanism have complementary configurations for engagement (a second coupling device 70…is mateable with the first coupling device 40 mentioned above; Column 5 Lines 62-65; those skilled in the art may readily appreciate how the first coupling device 40 is coupled with the second coupling device 70 as shown in FIGS. 7 through 12…uncoupling the couplers 40 and 70 is effected by reversing the steps described, i.e. by pressing the couplers together, rotating them to move the protrusion out of the locking seat, separating the couplers 42, 72 and lifting the ball coupler 74 out of the socket coupler 44; Column 6 Lines 37-65; Figures 7-12).
Regarding Claim 13, Palmer discloses wherein the core is configured for receiving a distal portion the cable and wire of the catheter portion (The distal end 72b of the female bayonet coupler 72 is crimped, soldered, or welded to the ground proximal end 58b of the short coil 58. The male ball coupler 74 is a substantially spherical member at the proximal end 60c of the pull wire 60; Column 6 Lines 22-31; a second coupling device 70…is mateable with the first coupling device 40 mentioned above; Column 5 Lines 62-65; those skilled in the art may readily appreciate how the first coupling device 40 is coupled with the second coupling device 70 as shown in FIGS. 7 through 12…uncoupling the couplers 40 and 70 is effected by reversing the steps described, i.e. by pressing the couplers together, rotating them to move the protrusion out of the locking seat, separating the couplers 42, 72 and lifting the ball coupler 74 out of the socket coupler 44; Column 6 Lines 37-65; Figures 7-12).
Claim Rejections - 35 USC § 103
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.
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.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Palmer in view of Kimura et al (U.S. Publication No. 2002/0045909).
Regarding Claim 14, although Palmer discloses wherein the engagement control is such that the engagement mechanism can be in a clamping position (distal movement of the pull wire 160 relative to the coil 158 will move the cylinder 150 over the arms 152e, 152f to thereby close the jaw cups 152a, 152b; Column 7 Lines 34-36), Palmer fails to specifically teach wherein the engagement control is biased such that the engagement mechanism is biased in a clamping position.
In a similar technical field, Kimura teaches a physiological tissue clipping apparatus, clipping method and clip unit mounting method (Abstract), wherein the engagement control is biased such that the engagement mechanism (clip unit 120) is biased in a clamping position (The manipulating section 150 is composed of a manipulating section main body 151, a slider 152, a manipulating pipe 153, a lock 154, a lock spring 155, and a slider spring 156; [0282]; an amount of push force of the slider spring 156 is smaller than that of the lock 154 rolling over the tip end side end face 154 b, and the slider 152 is temporarily fixed; [0286]; a slider spring 156 for biasing the slider 152 at the proximal end side is provided, whereby the clip unit 120 is engaged with a tip end of the coil sheath 9, as shown in FIG. 37, and the clip unit 120 can be automatically engaged with the coil sheath 9 while the clip unit is approached to a target physiological tissue, and stable manipulation can be carried out; [0289]; Examiner’s Note: Because a “clamping position” was never specified by the claims or specification, the term “clamping position” is being interpreted in its broadest, reasonable interpretation. The Examiner is interpreting a “clamping position” to be the position used when approaching the target, wherein stable manipulation can be carried out).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the biasing teachings of Kimura into the invention of Palmer in order to enable the device to be automatically engaged in order to carry out stable manipulation (Kimura [0289]).
Regarding Claim 15, Palmer discloses wherein the engagement control is moved to move the engagement mechanism from the clamping position (proximal movement the pull wire 160 relative to the coil 158 and will move the cylinder 150 back from the arms 152e, 152f to thereby open the jaw cups 152a, 152b).
Regarding Claim 16, Palmer discloses wherein the handle further comprises a distal handle portion arranged on the core (The handle assembly 12 includes a central shaft 16…a longitudinal bore 26 is provided at the distal end of the shaft 16; Column 5 Lines 21-27), but fails to specifically teach wherein the handle is configured to prevent inadvertent advancement of the engagement control.
In a similar technical field, Kimura teaches a physiological tissue clipping apparatus, clipping method and clip unit mounting method (Abstract), wherein the handle is configured to prevent inadvertent advancement of the engagement control (the lock 154 is slidably provided in the vertical direction in the figure at the manipulating section main body 151, and is always biased upwards in the figure by the lock spring 155; [0282]; an amount of push force of the slider spring 156 is smaller than that of the lock 154 rolling over the tip end side end face 154 b, and the slider 152 is temporarily fixed; [0286]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the lock teachings of Kimura into the invention of Palmer in order to temporarily fix the position of the slider, if needed, for stable manipulation to prevent any inadvertent movement (Kimura [0286-0289]).
Regarding Claim 17, Palmer fails to disclose wherein the handle has a locked position and an unlocked position.
In a similar technical field, Kimura discloses a physiological tissue clipping apparatus, clipping method and clip unit mounting method (Abstract), wherein the handle has a locked ([0286]) position and an unlocked ([0287]) position (The lock 154 is slidably provided in the vertical direction in the figure at the manipulating section main body 151, and is always biased upwards in the figure by the lock spring 155; [0282]; the slider 152 is temporarily fixed…release the slider 152 from a fixed state; [0286-0287]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the lock teachings of Kimura into the invention of Palmer in order to allow the user lock and unlock the device, by temporarily fixing the position of the slider to a locked position or by releasing the slider from the fixed state to an unlocked position (Kimura [0286-0287]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J JHIN/Examiner, Art Unit 3791