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
The restriction requirement of 08/28/2025 is withdrawn. Upon reconsideration, it is determined that the claims are not directed to independent or distinct inventions. Specifically, the claimed inventions/products are not distinct as they are the same invention/product.
Claims 16-18, which were previously withdrawn from consideration, are hereby rejoined and will be fully examined for patentability under 37 CFR 1.104.
A complete action on the merits of pending claims 1-20 appears below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/31/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Examiner notes, Applicant had listed the incorrect publication date of the Foreign reference (DE 212018000416 U1) listed on the IDS, therefore the IDS has been annotated to provide the correct date.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0023] should be amended to the following to fix an inconsistent reference number of a component in the Figures of the current invention, “Endoscope 102 may include a generally cylindrical tubular shape, and may include a proximal portion 102A, distal portion 102B, and an intermediate portion 102C. Although not shown, proximal portion 102A may include or otherwise be coupled to a handle, for example, including one or more ports, controls, levers, electrical or communication connections, etc. Additionally, endoscope 102 may include one or more internal lumens 112 or working channels, for example, extending longitudinally through endoscope 102. In these aspects, internal lumens 112 or working channels may extend through proximal portion 102A, intermediate portion 102C, and distal portion 102B, for example, terminating distally at one or more distal openings (i.e., in a distal most end of endoscope 102). As shown in FIG. 1 , when medical device 104, including patch 106, is coupled to endoscope 102 (i.e., during the delivery and positioning), patch 106 and a distal portion of medical device 104 may be coupled to distal portion 102B of endoscope, for example, coupled to and/or extending distally beyond the distal opening(s) of internal lumen(s) 112.”
Paragraph [0040] should be amended to the following to fix an inconsistent reference number of a component in the Figures of the current invention, “Although the figures illustrate two control elements 120, this disclosure is not so limited. For example, in some aspects, medical device 104 may include two or more patches 106, for example, movably coupled to end cap 108. In these aspects, medical device 104 may include two control elements 120 for each patch 106 (e.g., four control elements 120 for two patches 106, etc.), and a corresponding number of actuation element(s) 122 and sheath element(s) 124.”
The suggested amendments are illustrative only and must be supported by the as-filed disclosure to avoid introduction of new matter (35 U.S.C. 132(a)). Appropriate correction is required.
Claim Objections
Claims 14 and 20 are objected to because of the following informalities:
Claim 14 should be amended to the following, “The medical device of claim 13, wherein a position of the at least one hole on the stationary body corresponds to a position of the movable body on the stationary body in which the patch is extended from the end cap.” Given that this’s the first instance that the “position of the at least one hole on the stationary body” is referred to in the claims.
Claim 20 should be amended to the following to fix a minor grammatical error, “The medical device of claim 19, wherein the inner cap includes a prong extending radially inward and configured to abut a distal end face of the second medical device, wherein the patch includes one or more retention grooves configured to receive a portion of the one or more actuation elements to couple the patch to the one or more actuation elements, and wherein movement of the one or more actuation elements causes the one or more actuation elements to extend, bow, or bend radially outward and out of the one or more retention grooves to at least partially deploy the patch.”
Appropriate correction is required.
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.
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) 1-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPUB No. 20200038005 A1), in view of Jin (US PGPUB No. 20210059677 A1).
Regarding claim 1, Smith discloses, systems and methods of delivering a patch to a target site of a patient. Smith teaches, a medical device (Figure 1, endoscope (100); Paragraph [0038]), comprising:
a handle (Figure 1, controller (102); Paragraph [0038]), wherein the handle includes a movable body (Figure 1, first and second actuators (112 & 114); Paragraph [0039], actuators (112 & 114) being movable bodies/knobs that move relative to a stationary main body of controller (102) for steering/deflecting shaft (104)) and a stationary body (Figure 1, the main body of controller (102) being the stationary body relative to which movable components operate; Paragraphs [0038]-[0040]; the stationary main body of controller (102) houses ports/controls and remains fixed in the operator’s hand while actuators (112 & 114) are manipulated), and wherein the movable body includes an actuation member (Paragraph [0039]; actuators (112 & 114) include movable actuation components, e.g., knobs/wheels as seen in Figure 1 that are actuated /rotated for controlled deflection/movement; actuators (112 & 114) provide concerted movement for 360-degree manipulation);
an end cap (Figure 4A, cap (430); Paragraph [0050]) configured to be coupled to a distal end of a scope (Figures 4B-4C, distal end (406) of endoscope shaft (406); Paragraph [0051]);
a patch (Figure 4B, patch (840); Paragraph [0051]), wherein the patch is movable relative to the end cap (Figures 4B-4C; Paragraphs [0051]-[0053], patch (840) movable/releasable from cap (430)),
wherein the patch is coupled to the movable body via one or more control elements (Figures 4A-4C, band (470)/ridge (435); Paragraphs [0050]-[0052]) such that movement of the movable body extends the patch from the end cap (Paragraphs [0039]-[0040] and [0050]-[0053]; patch (840) coupled via band (470)/ridge (435) on cap (430) to endoscope shaft (404)/working channel, with shaft (404) controlled by movable actuators (112 & 114) as control elements/steering wires such that actuator movement deflects/extends/positions shaft (404) distally to press/extend patch (840) from cap (430) toward tissue; Alternatively, in instrument embodiments like Figures 2A-2C/3A-3D, shafts (252/352) as control elements couple to handle/controller for extending patches (800/820) from endoscope/channel/cap-like distal end; Paragraphs [0041]-[0049]), and
wherein the patch is further coupled to the actuation member via one or more actuation elements such that movement of the actuation member at least partially deploys the patch (Paragraph [0052], patch (840) coupled via band (470), which is cut/released by wire/mechanism coupled to actuator on handle/controller for deployment; Alternatively, in Figures 5A-5D, patch (860) coupled to balloon (556) via shaft (552)/fluid channel as actuation elements, with inflation/deflation actuated via handle controls to deploy/expand patch (Paragraphs [0054]-[0056])).
Smith does not explicitly teach, wherein movement of the actuation member extends, bows, or bends the one or more actuation elements to at least partially deploy the patch (while Smith teaches actuation for deployment, it does not detail bowing/bending of elements).
Jin discloses, endoscopic delivery systems for GI tissue-clamping/hemostatic devices. Jin teaches, a handle (Figure 6, handle (4); Paragraph [0103]), wherein the handle includes a movable body (Figure 6, slider (402)) and a stationary body (Figure 6, core bar (401)), wherein the movable body includes an actuation member (Paragraphs [0109]-[0112], slider (402) itself serves as the actuation member, movable via user input to pull proximally for deployment), an end cap (Figures 6-8, transparent cap (203)) configured to be coupled to a distal end of a scope (Figures 6 and 7B, endoscope (5)) (Paragraphs [0076]-[0082]; transparent cap (203) coupled to endoscope (5) via soft connection cap (204)), a device/patch-like clamp (Figure 6, clamp (1) with ring/lancet structure analogous to a deployable patch/barrier for tissue closure/hemostasis; Paragraphs [0069]-[0074] and [0094]-[0097]), movable relative to the end cap (Paragraphs [0078]-[0086]; clamp (1) assembled/movable in cap (203), extendable/releasable therefrom), coupled to the movable body via one or more control elements (Figure 6, middle flexible sheath (3) with inner operation (302) as control elements coupling handle (4) to distal end; Paragraphs [0076] and [0103]-[0112]; movement of slider (402) pulls cable/sheath to extend/release clamp from cap) such that movement of the movable body extends the device from the end cap (Paragraphs [0109]-[0112]; proximal sliding of slider (402) extends/pushes clamp from cap via thrust ring (201)), and further coupled to the actuation member via one or more actuation elements (Figures 6-8, pulling cable (202) as wires/cables threaded through cap/thrust ring; Paragraphs [0078]-[0085]) such that movement of the actuation member extends, bows, or bends the one or more actuation elements to at least partially deploy the device (Figures 7A-8; Paragraphs [0086]-[0087] and [0109]-[0112]; proximal movement of slider (402) pulls cable (202), causing Ω-shaped cable to deform/extend/bow/bend/straighten radially during pulling, lifting bottom portion to push thrust ring (201) distally and deploy clamp; cable bows/bends outward/under force to release; deformation provides controlled bending for stable deployment).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s handle (controller (102) with stationary main body and movable actuators (112 & 114)) and actuation elements (e.g., band-cutting wire or balloon channel) to incorporate Jin’s handle configuration (handle (4) with explicit stationary core bar (401), movable slider (402) as both movable body and actuation member) and bowing/bending actuation elements (pulling cable (202) that extends/bows/bends/deforms proximally to deploy via thrust ring push), as both references and the claimed invention are directed to endoscopic delivery systems for GI tissue-clamping/hemostatic devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s handle (controller (102) with stationary main body and movable actuators (112 & 114)) and actuation elements (e.g., band-cutting wire or balloon channel) to incorporate Jin’s handle configuration (handle (4) with explicit stationary core bar (401), movable slider (402) as both movable body and actuation member) and bowing/bending actuation elements (pulling cable (202) that extends/bows/bends/deforms proximally to deploy via thrust ring push), as such a modification would have been predictable, namely, in order to provide a more precise, user-friendly sliding actuation mechanism for controlled extension and deployment in endoscopic GI procedures (See Jin, Paragraphs [0086]-[0087], [0103], and [0109]-[0112]). This modification is no more than the predictable results from substituting/combining known handle/slider and cable bending mechanisms in endoscopic delivery for improved stability, minimal tissue damage, and reliable release, per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): simple substitution of one known element for another to obtain predictable results; MPEP 2143(I)(B); further, Graham v. John Deere Co., 383 U.S. 1 (1966): differences are minor and addressed by secondary reference teaching known improvements in analogous art.
Regarding claim 2, modified Smith teaches, wherein the actuation member is movably positioned within a slot on the movable body of the handle (Figure 6 and Paragraph [0103] of Jin; slider (402) (actuation member) is indeed movably positioned within slot/track of slider mechanism on movable body/slider itself, or integrated as sliding within core bar (401); obvious to integrate slot for guided sliding, per rationale above).
Regarding claim 3, modified Smith teaches, wherein the end cap includes an outer cap and an inner cap, wherein the patch is movably positioned between the outer cap and the inner cap (Figures 4A-4C and Paragraphs [0050]-[0051] of Smith, cap (430) with outer surface that comprises ridge (435) as outer/inner portions with patch (840) movably positioned between/over ridge layers; Paragraph [0080] of Jin, double-layered transparent cap (203) with inner/outer layers for positioning clamp; obvious combination for secure, layered movable positioning).
Regarding claim 4, modified Smith teaches, wherein the inner cap includes a prong extending radially inward and configured to abut a distal end face of the scope (Paragraphs [0076]-[0077], [0082], and [0087] of Jin, soft connection cap (204) with elastic material forming inward-gripping/prong-like clamp/abutment on scope end face for secure fit; obvious for abutting stability).
Regarding claim 5, modified Smith teaches, further comprising a protective element positioned at a distal end of the one or more actuation elements and configured to at least partially seal an opening between the outer cap and the inner cap (Figures 4B-4C and Paragraph [0051] of Smith, band (470) as protective/sealing element over patch opening; Figure 7B and Paragraph [0078] of Jin, thrust ring (201) positioned at distal end of cable (202), sealing positioning between cap layers; obvious for protection/sealing during delivery).
Regarding claim 6, modified Smith teaches, wherein the patch includes one or more retention grooves configured to receive a portion of the one or more actuation elements to couple the patch to the one or more actuation elements (Figures 1-2, 6-8, and Paragraphs [0070], [0076] and [0092] of Jin, clamp (analogous patch) with round corners (103) as groove-like arcs/indentations receiving portions of cable (202) for coupling/retention; obvious to adapt grooves for Smith’s patch to ensure secure coupling during extension).
Regarding claim 7, modified Smith teaches, wherein the one or more retention grooves are positioned on a radially exterior portion of the patch when the patch is in an undeployed configuration (Figures 1-3, 6-8, and Paragraphs [0092]-[0096] of Jin, corners (103)/grooves on radially exterior of clamp ring in undeployed cylindrical state; obvious exterior positioning for radial release).
Regarding claim 8, Smith further teaches, wherein the end cap includes an end cap ring (Paragraph [0050] and Figure 4A of Smith, ridge (435) as end cap ring/flange), and wherein at least a portion of the end cap is transparent (Paragraph [0050] of Smith, the cap may be at least partially or completely transparent).
Regarding claim 9, modified Smith teaches, wherein the one or more actuation elements are formed of a shape-memory material (Paragraphs [0110] of Jin, Ni-Ti alloy for cable/wire elements (pulling cable (202)) with hyperelastic/shape-memory properties for deformation/recovery).
Regarding claim 10, modified Smith teaches, further comprising one or more sheath elements coupling the handle to the end cap, wherein each of the one or more actuation elements are movably positioned within one of the one or more control elements, and wherein each of the one or more control elements are movably positioned within one of the one or more sheath elements (Figures 6-7B and Paragraphs [0076]-[0077] & [0103] of Jin; flexible outer pipe (301) (sheath elements) coupling handle (4) to cap (203), with actuation cable (202) movably within control cable (302), and cable (302) within sheath (301); obvious to integrate, per rationale above of claim 1).
Regarding claim 11, modified Smith teaches, wherein the one or more actuation elements are each formed of one or more wires (Paragraph [0052] of Smith, wires for band cutting; Paragraph [0110] of Jin, pulling cable (202) as wires (e.g., stainless steel/NiTi wire)), and wherein the one or more control elements are each formed of one or more coils (Paragraph [0103] of Jin, flexible outer pip (301). While the instant claim requires the one or more control elements to be formed of one or more coils, the Specification (at Paragraph [0027]) explicitly lists "coil" as one of many suitable formations for the control element. The selection of coil from this list, which includes other formation such as tube or sheath, is merely a result of routine optimization or selection of known alternatives. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to substitute the control element formation in Jin with coils, as taught by the Applicant’s own specification, to achieve a known, predictable result) (Obvious wire/coil forms for flexibility).
Regarding claim 12, modified Smith teaches, wherein the movable body of the handle is movable within a slot in the stationary body of the handle (Figure 6 and Paragraph [0103] of Jin; movable slider (402) slides within slot/track in stationary core bar (401)).
Regarding claim 13, modified Smith teaches, wherein the movable body of the handle includes at least one peg, wherein the stationary body of the handle includes at least one hole, and wherein the at least one peg is configured to engage with the at least one hole to at least partially secure a position of the movable body on the stationary body (Figure 6 and Paragraph [0103] of Jin, slider (402) and core bar (401) indicate peg/hole detent/engagement for securing slider positions during sliding; obvious known locking mechanism in handles for secure positioning, per predictable results; MPEP 2143(I)(A)).
Regarding claim 14, modified Smith teaches, wherein a position of the at least one hole on the stationary body corresponds to a position of the movable body on the stationary body in which the patch is extended from the end cap (obvious correspondence of hole/peg to extension/deployment position for secure holding during procedure; per rationale above).
Regarding claim 15, Smith further teaches, wherein the patch includes a hemostatic agent (Paragraphs [0025]-[0030] of Smith; hemostatic chitosan/ECM biomaterials).
Regarding claim 17, Smith teaches, wherein the end cap (cap (430)) includes an outer cap and an inner cap, wherein the patch is movably positioned between the outer cap and the inner cap (Figures 4A-4C and Paragraphs [0050]-[0051], cap (430) with outer surface that comprises ridge (435) as outer/inner portions with patch (840) movably positioned between/over ridge layers).
Smith does not explicitly teach, wherein the inner cap includes a prong extending radially inward and configured to abut the distal end face of the endoscope.
Jin teaches, a double-layered transparent end cap (Figures 6-8, transparent cap (203)) that includes an outer cap and an inner cap, wherein the device/patch-like clamp (Figure 6, clamp (1)) is movably positioned between the outer cap and the inner cap (Paragraph [0080]), and wherein the inner cap includes a prong extending radially inward and configured to abut the distal end face of the endoscope (Paragraphs [0076]-[0077], [0082], and [0087]; soft connection cap (204) with elastic material forming inward-gripping/prong-like clamp/abutment on scope end face for secure axial positioning and abutment against the distal end face of endoscope (5)). Jin further teaches, a handle (Figure 6, handle (4); Paragraph [0103]), wherein the handle includes a movable body (Figure 6, slider (402)) and a stationary body (Figure 6, core bar (401)), wherein the movable body includes an actuation member (Paragraphs [0109]-[0112], slider (402) itself serves as the actuation member, movable via user input to pull proximally for deployment), an end cap (transparent cap (203)) configured to be coupled to a distal end of a scope (Figures 6 and 7B, endoscope (5)) (Paragraphs [0076]-[0082]; transparent cap (203) coupled to endoscope (5) via soft connection cap (204)), a device/patch-like clamp (Figure 6, clamp (1) with ring/lancet structure analogous to a deployable patch/barrier for tissue closure/hemostasis; Paragraphs [0069]-[0074] and [0094]-[0097]), movable relative to the end cap (Paragraphs [0078]-[0086]; clamp (1) assembled/movable in cap (203), extendable/releasable therefrom), coupled to the movable body via one or more control elements (Figure 6, middle flexible sheath (3) with inner operation (302) as control elements coupling handle (4) to distal end; Paragraphs [0076] and [0103]-[0112]; movement of slider (402) pulls cable/sheath to extend/release clamp from cap) such that movement of the movable body extends the device from the end cap (Paragraphs [0109]-[0112]; proximal sliding of slider (402) extends/pushes clamp from cap via thrust ring (201)), and further coupled to the actuation member via one or more actuation elements (Figures 6-8, pulling cable (202) as wires/cables threaded through cap/thrust ring; Paragraphs [0078]-[0085]) such that movement of the actuation member extends, bows, or bends the one or more actuation elements to at least partially deploy the device (Figures 7A-8; Paragraphs [0086]-[0087] and [0109]-[0112]; proximal movement of slider (402) pulls cable (202), causing Ω-shaped cable to deform/extend/bow/bend/straighten radially during pulling, lifting bottom portion to push thrust ring (201) distally and deploy clamp; cable bows/bends outward/under force to release; deformation provides controlled bending for stable deployment).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s radial end cap (430) by incorporating Jin’s double-layered transparent cap structure (203) with distinct outer and inner layers for securely positioning the patch/clamp therebetween, and further incorporating the soft connection cap (204) providing a radially inward prong-like abutment/grip that abuts the distal end face of the endoscope for precise axial positioning and secure attachment, as both references and the claimed invention are directed to endoscopic delivery systems for GI tissue-clamping/hemostatic devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s radial end cap (430) by incorporating Jin’s double-layered transparent cap structure (203) with distinct outer and inner layers for securely positioning the patch/clamp therebetween, and further incorporating the soft connection cap (204) providing a radially inward prong-like abutment/grip that abuts the distal end face of the endoscope for precise axial positioning and secure attachment, as such a modification would have been predictable, namely, in order to provide more reliable and precise positioning of the patch between distinct cap layers, better protection during delivery, and more secure and accurate axial registration against the endoscope distal face without obstructing visualization (See Jin, Paragraphs [0076]-[0082] and [0087]). This modification is no more than the predictable results from combining known layered cap designs and prongs/abutment attachment features in endoscopic caps for improved stability and alignment, per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): simple substitution/combination of one known element for another to obtain predictable results; MPEP 2143(I)(B); further, Graham v. John Deere Co., 383 U.S. 1 (1966): differences are minor and addressed by secondary reference teaching known improvements in analogous art.
Regarding claim 18, Smith teaches, further comprising a protective element positioned at a distal end of the one or more actuation elements and configured to at least partially seal an opening between the outer cap and the inner cap (Figures 4B-4C and Paragraph [0051], band (470) as protective/sealing element over patch opening).
Smith does not explicitly teach, wherein the patch includes one or more retention grooves configured to receive a portion of the one or more actuation elements to couple the patch to the one or more actuation elements, and wherein movement of the one or more actuation elements extends, bows, or bends the one or more actuation elements radially outward and out of the one or more retention grooves.
Jin teaches, a protective element positioned at a distal end of the one or more actuation elements and configured to at least partially seal an opening between the outer cap and the inner cap (Figure 7B and Paragraph [0078], thrust ring (201) positioned at distal end of cable (202), sealing positioning between cap layers; obvious for protection/sealing during delivery), and the patch includes one or more retention grooves configured to receive a portion of the one or more actuation elements to couple the patch to the one or more actuation elements (Figures 1-2, 6-8, and Paragraphs [0070], [0076] and [0092] of Jin, clamp (analogous patch) with round corners (103) as groove-like arcs/indentations receiving portions of cable (202) for coupling/retention), and wherein movement of the one or more actuation elements extends, bows, or bends the one or more actuation elements radially outward and out of the one or more retention grooves (Figures 7A-8; Paragraphs [0086]-[0087] and [0109]-[0112]; proximal movement of slider (402) pulls cable (202), causing the Ω-shaped portion of cable (202) to deform/extend/bow/bend/straighten and lift radially outward/upward, disengaging/lifting out of contact with the round-corner retention/groove structures (103) on clamp (1), thereby releasing the clamp from the cap; this radial outward deformation and disengagement provides controlled, stable deployment).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s patch (840) and radial end-cap delivery system (cap (430) with band (470)) by incorporating Jin’s retention groove-like round corners (103) on the clamp/patch structure that receive and retain the actuation cable (202), together with the cable’s radial outward bowing/deformation/disengagement upon actuation to release the device, as both references and the claimed invention are directed to endoscopic delivery systems for GI tissue-clamping/hemostatic devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s patch (840) and radial end-cap delivery system (cap (430) with band (470)) by incorporating Jin’s retention groove-like round corners (103) on the clamp/patch structure that receive and retain the actuation cable (202), together with the cable’s radial outward bowing/deformation/disengagement upon actuation to release the device, as such a modification would have been predictable, namely, in order to provide more secure mechanical coupling and retention of the patch/clamp during delivery inside the cap, followed by reliable, controlled release via simple proximal cable pull without requiring cutting or inflation, thereby improving deployment precision and reducing risk of premature dislodgement or tissue trauma in tortuous GI anatomy (See Jin, Paragraphs [0070], [0092], [0096], and [0109]-[0112]). This modification is no more than the predictable results from combining known groove/retention features and cable deformation release mechanisms in endoscopic delivery devices for improved stability, secure holding, and clean disengagement, per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): simple substitution/combination of one known element for another to obtain predictable results; MPEP 2143(I)(B); further, Graham v. John Deere Co., 383 U.S. 1 (1966): differences are minor and addressed by secondary reference teaching known improvements in analogous art.
Regarding claim 19, Smith teaches, a medical device (Figure 4B; Paragraphs [0050]-[0053]), comprising:
a handle (Figure 1, controller (102); Paragraph [0038]), wherein the handle includes a movable body (Figure 1, first and second actuators (112 & 114); Paragraph [0039], actuators (112 & 114) being movable bodies/knobs that move relative to a stationary main body of controller (102) for steering/deflecting shaft (104)) and a stationary body (Figure 1, the main body of controller (102) being the stationary body relative to which movable components operate; Paragraphs [0038]-[0040]; the stationary main body of controller (102) houses ports/controls and remains fixed in the operator’s hand while actuators (112 & 114) are manipulated), and wherein the movable body includes an actuation member (Paragraph [0039]; actuators (112 & 114) include movable actuation components, e.g., knobs/wheels as seen in Figure 1 that are actuated /rotated for controlled deflection/movement; actuators (112 & 114) provide concerted movement for 360-degree manipulation);
an end cap (Figure 4A, cap (430); Paragraph [0050]) configured to be coupled to a distal end (Figures 4B-4C, distal end (406) of endoscope shaft (406); Paragraph [0051]) of a second medical device (Figure 1, endoscope (100); Paragraph [0038]), wherein the end cap includes an outer cap and an inner cap (Figures 4A-4C and Paragraphs [0050]-[0051] of Smith, cap (430) with outer surface that comprises ridge (435) as outer/inner portions); and
a patch (Figure 4B, patch (840); Paragraph [0051]), wherein the patch is movably positioned between the outer cap and the inner cap (patch (840) movably positioned between/over ridge layers),
wherein the patch is coupled to the movable body via one or more control elements (Figures 4A-4C, band (470)/ridge (435); Paragraphs [0050]-[0052]) such that distal movement of the movable body extends the patch from the end cap (Paragraphs [0039]-[0040] and [0050]-[0053]; patch (840) coupled via band (470)/ridge (435) on cap (430) to endoscope shaft (404)/working channel, with shaft (404) controlled by movable actuators (112 & 114) as control elements/steering wires such that actuator movement deflects/extends/positions shaft (404) distally to press/extend patch (840) from cap (430) toward tissue; Alternatively, in instrument embodiments like Figures 2A-2C/3A-3D, shafts (252/352) as control elements couple to handle/controller for extending patches (800/820) from endoscope/channel/cap-like distal end; Paragraphs [0041]-[0049]), and
wherein the patch is further coupled to the actuation member via one or more actuation elements such that movement of the actuation member at least partially deploys the patch (Paragraph [0052], patch (840) coupled via band (470), which is cut/released by wire/mechanism coupled to actuator on handle/controller for deployment; Alternatively, in Figures 5A-5D, patch (860) coupled to balloon (556) via shaft (552)/fluid channel as actuation elements, with inflation/deflation actuated via handle controls to deploy/expand patch (Paragraphs [0054]-[0056])).
Smith does not explicitly teach, the actuation member movable within a slot in the movable body in combination with the double-layered end cap having the patch movably positioned between outer and inner cap.
Jin teaches, the handle configuration wherein the actuation member (slider (402)) is movable within a slot in the movable body (Figure 6 and Paragraph [0103]; slider (402) slides linearly within a guiding slot/track integrated with or formed on the movable body/core bar (401) assembly for precise, controlled proximal pull/deployment), and the end cap includes an outer cap and an inner cap, wherein the device/patch-like clamp (1) is movably positioned between the outer cap and the inner cap (Paragraph [0080]; double-layered transparent cap (203) with distinct outer and inner layers providing a space/channel in which clamp (1) is assembled, retained, and movably positioned during delivery and prior to release).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s handle (controller (102) with stationary main body and movable actuators (112 & 114)) and radial end cap (430) by incorporating Jin’s handle configuration with a slider actuation member movable within a slot on the movable body, together with Jin’s double-layered transparent end cap having the patch/clamp movably positioned between outer and inner layers, as both references and the claimed invention are directed to endoscopic delivery systems for GI tissue-clamping/hemostatic devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s handle (controller (102) with stationary main body and movable actuators (112 & 114)) and radial end cap (430) by incorporating Jin’s handle configuration with a slider actuation member movable within a slot on the movable body, together with Jin’s double-layered transparent end cap having the patch/clamp movably positioned between outer and inner layers, as such a modification would have been predictable, namely, in order to provide more precise, linear, and user-friendly actuation of deployment (via slot-guided sliding) while securely retaining and movably positioning the patch/clamp between distinct cap layers for better protection during delivery, improved alignment, and reliable extension/release in endoscopic GI procedures (See Jin, Paragraphs [0080], [0103], [0109]-[0112]). This modification is no more than the predictable results from combining known slot-guided slider handles and layered cap designs in endoscopic delivery devices for enhanced control, secure storage, and stable deployment, per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): simple substitution/combination of one known element for another to obtain predictable results; MPEP 2143(I)(B); further, Graham v. John Deere Co., 383 U.S. 1 (1966): differences are minor and addressed by secondary reference teaching known improvements in analogous art.
Regarding claim 20, Smith teaches, aspects of the medical device according to claim 19 (See above rejection of claim 19).
Smith does not explicitly teach, wherein the inner cap includes a prong extending radially inward and configured to abut a distal end face of the second medical device, wherein the patch includes one or more retention grooves configured to receive a portion of the one or more actuation elements to couple the patch to the one or more actuation elements, and wherein movement of the one or more actuation elements causes the one or more actuation elements to extend, bow, or bend radially outward and out of the one or more retention grooves to at least partially deploy the patch.
Jin teaches, wherein the inner cap includes a prong extending radially inward and configured to abut a distal end face of the second medical device (Figure 6; Paragraphs [0076]-[0077], [0082], and [0087], soft connection cap (204) with elastic material forming inward-gripping/prong-like clamp/abutment on scope end face for secure fit), wherein the patch includes one or more retention grooves configured to receive a portion of the one or more actuation elements to couple the patch to the one or more actuation elements (Figures 1-2, 6-8, and Paragraphs [0070], [0076] and [0092], clamp (analogous patch) with round corners (103) as groove-like arcs/indentations receiving portions of cable (202) for coupling/retention), and wherein movement of the one or more actuation elements causes the one or more actuation elements to extend, bow, or bend radially outward and out of the one or more retention grooves to at least partially deploy the patch (Figures 7A-8; Paragraphs [0086]-[0087] and [0109]-[0112]; proximal movement of slider (402) pulls cable (202), causing the Ω-shaped portion of cable (202) to deform/extend/bow/bend/straighten and lift radially outward/upward, disengaging/lifting out of contact with the round-corner retention/groove structures (103) on clamp (1), thereby releasing the clamp from the cap; this radial outward deformation and disengagement provides controlled, stable deployment).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s radial end-cap delivery system (cap (430) with patch (840)) and actuation mechanism (band (470)/cutting wire or balloon inflation) by incorporating Jin’s radially inward prong/abutment feature on the inner cap (via soft connection cap (204)), together with Jin’s retention groove-like round corners (103) on the clamp/patch structure that receive and retain the actuation cable (202), and the cable’s radial outward bowing/deformation/disengagement upon actuation to release the device, as both references and the claimed invention are directed to endoscopic delivery systems for GI tissue-clamping/hemostatic devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s radial end-cap delivery system (cap (430) with patch (840)) and actuation mechanism (band (470)/cutting wire or balloon inflation) by incorporating Jin’s radially inward prong/abutment feature on the inner cap (via soft connection cap (204)), together with Jin’s retention groove-like round corners (103) on the clamp/patch structure that receive and retain the actuation cable (202), and the cable’s radial outward bowing/deformation/disengagement upon actuation to release the device, as such a modification would have been predictable, namely, in order to provide precise axial registration against the endoscope distal face, secure retention of the patch during delivery and extension inside the cap, and reliable, controlled release via simple proximal cable pull without additional cutting or inflation steps thereby improving deployment accuracy, reducing premature dislodgement risk, and minimizing tissue trauma in tortuous GI anatomy (See Jin, Paragraphs [0070], [0076]-[0077], [0082], [0087], [0092], [0096], and [0109]-[0112]). This modification is no more than the predictable results from combining known prong/abutment attachment features, groove/retention mechanisms, and cable deformation release mechanisms in endoscopic delivery devices for enhanced alignment, secure holding, and clean disengagement, per KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007): simple substitution/combination of one known element for another to obtain predictable results; MPEP 2143(I)(B); further, Graham v. John Deere Co., 383 U.S. 1 (1966): differences are minor and addressed by secondary reference teaching known improvements in analogous art.
Claim Rejections - 35 USC § 102
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith.
Regarding claim 16, Smith discloses, a medical system (Paragraph [0024] and [0037]), comprising:
an endoscope (Figure 1, endoscope (100); Paragraph [0038]), including a distal end (Figures 4B-4C, distal end (406) of endoscope shaft (406); Paragraph [0051]) including one or more visualization devices on a distal end face (Figures 4B-4C, optical device (425); Paragraph [0051]);
a medical device (Figure 4B; Paragraphs [0050]-[0053]), wherein the medical device includes:
a handle (Figure 1, controller (102); Paragraph [0038]), wherein the handle includes a movable body (Figure 1, first and second actuators (112 & 114); Paragraph [0039], actuators (112 & 114) being movable bodies/knobs that move relative to a stationary main body of controller (102) for steering/deflecting shaft (104)) and a stationary body (Figure 1, the main body of controller (102) being the stationary body relative to which movable components operate; Paragraphs [0038]-[0040]; the stationary main body of controller (102) houses ports/controls and remains fixed in the operator’s hand while actuators (112 & 114) are manipulated), and wherein the movable body includes an actuation member (Paragraph [0039]; actuators (112 & 114) include movable actuation components, e.g., knobs/wheels as seen in Figure 1 that are actuated /rotated for controlled deflection/movement; actuators (112 & 114) provide concerted movement for 360-degree manipulation);
end cap (Figure 4A, cap (430); Paragraph [0050]) configured to be coupled to a radial exterior of the distal end of the endoscope (Figures 4B-4C; Paragraph [0051]); and
a patch (Figure 4B, patch (840); Paragraph [0051]), wherein the patch is movable relative to the end cap (Figures 4B-4C; Paragraphs [0051]-[0053], patch (840) movable/releasable from cap (430)),
wherein the patch is coupled to the movable body via one or more control elements (Figures 4A-4C, band (470)/ridge (435); Paragraphs [0050]-[0052]) such that movement of the movable body extends the patch from the end cap (Paragraphs [0039]-[0040] and [0050]-[0053]; patch (840) coupled via band (470)/ridge (435) on cap (430) to endoscope shaft (404)/working channel, with shaft (404) controlled by movable actuators (112 & 114) as control elements/steering wires such that actuator movement deflects/extends/positions shaft (404) distally to press/extend patch (840) from cap (430) toward tissue; Alternatively, in instrument embodiments like Figures 2A-2C/3A-3D, shafts (252/352) as control elements couple to handle/controller for extending patches (800/820) from endoscope/channel/cap-like distal end; Paragraphs [0041]-[0049]), and
wherein the patch is further coupled to the actuation member via one or more actuation elements such that movement of the actuation member at least partially deploys the patch (Paragraph [0052], patch (840) coupled via band (470), which is cut/released by wire/mechanism coupled to actuator on handle/controller for deployment; Alternatively, in Figures 5A-5D, patch (860) coupled to balloon (556) via shaft (552)/fluid channel as actuation elements, with inflation/deflation actuated via handle controls to deploy/expand patch (Paragraphs [0054]-[0056])).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771