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 .
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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burke (US 2021/0260335).
Regarding claim 20, Burke discloses method for treating a wound cavity with a medical device, comprising:
positioning a shaft (110) of the medical device at the wound cavity ([0050], figures 1-3), wherein a cap assembly (122) is mounted onto the shaft such that the cap assembly is positioned adjacent to the wound cavity (figure 3);
extending a porous body (160) out from within the cap assembly in response to moving a tube (150) relative to the cap assembly, such that the porous body expands upon exiting the cap assembly and entering the wound cavity ([0045]-[0048]), wherein the tube is coupled to the porous body and in fluid communication with a negative pressure source (132, [0027], figure 1); and
applying a negative pressure at the wound cavity via the porous body in response to activating the negative pressure source ([0034]).
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.
Claims 1-2, 6-7, 10, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burke (US 2021/0260335) in view of Hindmarsh (US 2019/0117857).
Regarding claim 1, Buke discloses a medical system comprising:
a handle (112, figure 1, [0027]);
a shaft (120, figure 1) extending distally from the handle, the shaft including one or more channels extending between the handle and a distal end of the shaft ([0028]);
a cap assembly (122) coupled to the distal end of the shaft (figure 1), the cap assembly including an opening (opening at the distal end) that is configured to expose the one or more channels at the distal end of the shaft ([0029]), and
a porous body (160, figures 2A-2B) movably disposed within the chamber, the porous body is configured to transition from a compressed configuration when disposed inside the chamber to an expanded configuration upon extending outwardly from the chamber ([0045]-[0048], figures 2A-2B).
Burke does not disclose a chamber that extends distally from the opening.
Hindmarsh teaches a vacuum therapy device in the same field of art and teaches the cap assembly includes a chamber (306) that extends distally from the opening (Figs. 4A, 4B: Tube 304, which contains porous medium 306, extends distally from adapter 320, [0076]-[0086]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filling date to modify the system of Burke by the cap assembly includes a chamber that extends distally from the opening, as taught by Hindmarsh, to achieve the predictable result of compressing the porous body until it is deployed and allowed to expand (see [0086] Hindmarsh).
Regarding claim 2, Hindmarsh further discloses a tube (304) movably coupled to the cap assembly, the tube is configured to move between a first position and a second position relative to the cap assembly to transition the porous body between the compressed configuration and the expanded configuration (figures 4A-4B, [0078], [0086], [0092]).
Regarding claim 6, Burke further teaches the chamber is configured to receive the tube when the tube is in the second position, and at least a portion of the chamber is deformable to facilitate releasing the tube from the chamber. (Fig. 3: Outer tube 150 can be actuated to deflect, bend, pivot, etc. to be positioned in the target treatment site 22, [0052] Burke.).
Regarding claim 7, Burke further discloses wherein the chamber is configured to receive the tube when the tube is in the second position (figures 2A-2B), and the chamber includes a slot that is configured to release the tube from the chamber (154 comprises a slot that releases the tube from chamber, figures 2A-2B).
Regarding claim 10, Burke further discloses the porous body is a sponge, a gauze, a film, or a membrane. (The expandable member 160 may be a sponge, [0039] Burke.)
Regarding claim 16, Burke discloses a medical device, comprising:
a cap assembly (122) configured to be attached about a shaft (12) of an endoscope (110, [0027])) such that a working channel of the endoscope is accessible through an opening of the cap assembly at a distal end of the shaft ([0028]),
a porous body (160, figures 2a-2b) received within the chamber (outer tube 150 forms a chmber), the chamber configured to compress the porous body relative to the shaft; wherein the porous body is movable relative to the cap assembly from a first position inside the chamber and in a compressed configuration to a second position outside of the chamber and in an expanded configuration ([0045]-[0048], figures 2A-2B).
Burke does not disclose the cap assembly including a chamber that extends distally from the distal end.
Hindmarsh teaches a vacuum therapy device in the same field of art and teaches the cap assembly includes a chamber (306) that extends distally from the opening (Figs. 4A, 4B: Tube 304, which contains porous medium 306, extends distally from adapter 320, [0076]-[0086]).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filling date to modify the system of Burke by the cap assembly includes a chamber that extends distally from the opening, as taught by Hindmarsh, to achieve the predictable result of compressing the porous body until it is deployed and allowed to expand (see [0086] Hindmarsh).
Regarding claim 17, Burke does not teach a tube disposed inside the working channel, the tube is coupled to a negative pressure source at a first end and to the porous body at a second end, such that the negative pressure source is in fluid communication with the porous body via the tube; wherein the tube is movable relative to the working channel to extend the porous body out from the chamber, and configured to generate a vacuum through the porous body in response to activating the negative pressure source.
Hindmarsh clearly teaches a tube disposed inside the working channel, the tube is coupled to a negative pressure source at a first end and to the porous body at a second end, such that the negative pressure source is in fluid communication with the porous body via the tube; wherein the tube is movable relative to the working channel to extend the porous body out from the chamber, and configured to generate a vacuum through the porous body in response to activating the negative pressure source. (Figs. 4A, 4B: The applicator 310 is moveable relative to tube 304 to move the porous medium 306 out of the tube 304 and into the defect cavity 102. then a vacuum apparatus applies a negative pressure to the porous medium 306, [0078], [0086], [0092] Hindmarsh.)
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filling date to modify the system of Burke by the generating negative pressure to the porous medium, as taught by Hindmarsh, to achieve the predictable result of compressing the porous body until it is deployed and allowed to expand (see [0086] Hindmarsh).
Regarding claim 18, Burke combined with Hindmarsh clearly teaches the chamber is configured to receive the tube when the tube extends the porous body out from the chamber, (Fig. 1: Inner tube 140 extends out of outer tube 150 Burke.) and at least a portion of the chamber is deformable to facilitate releasing the tube from the chamber. (Fig. 3: Outer tube 150 can be actuated to deflect, bend, pivot, etc. to be positioned in the target treatment site 22, [0052] Burke.)
Regarding claim 19, Burke further discloses wherein the chamber is configured to receive the tube when the tube is in the second position (figures 2A-2B), and the chamber includes a slot that is configured to release the tube from the chamber (154 comprises a slot that releases the tube from chamber, figures 2A-2B).
Claims 9, 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Burke (US 2021/0260335) in view of Hindmarsh (US 2019/0117857) further in view of Smith (US 2013/0331855).
Regarding claim 9, Burke combined with Hindmarsh clearly teaches the cap assembly.
However, Burke combined with Hindmarsh does not explicitly teach the cap assembly is selectively rotatable about the exterior surface of the distal end of the shaft such that the chamber is repositionable relative to the one or more channels while maintaining alignment with the working channel.
In an analogous art, Smith, which discloses an endoscope system, clearly teaches the cap assembly is selectively rotatable about the exterior surface of the distal end of the shaft such that the chamber is repositionable relative to the one or more channels while maintaining alignment with the working channel. (Fig. 3: Cap 110 can be rotated to align a particular working channel with tube 118, [0048].)
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one with ordinary skill in the art to modify the system of Burke combined with Hindmarsh by the cap assembly is selectively rotatable about the exterior surface of the distal end of the shaft such that the chamber is repositionable relative to the one or more channels while maintaining alignment with the working channel, as taught by Smith, for the benefit of allowing multiple working channels to align with the chamber ([0048]).
Regarding claim 11, Burke discloses wherein the tubing at least partially transparent such that the porous body disposed inside the tubing is visible through the chamber ([0030, transparent window/opening) but does not disclose the chamber at least partially transparent such that the porous body disposed inside the tubing is visible through the chamber.
Smith further teaches wherein the chamber is at least partially transparent such that the porous body disposed inside the chamber is visible through the chamber ([0050]).
Smith provides the window in order to allowing physicians to visualize the lesion being resected ([0050]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burke with Smith in order to allow further sections of the device to be visible to imaging.
Regarding claim 12, Burke discloses wherein the chamber includes a window such that the porous body disposed inside the chamber is visible through the window by an imaging device ([0030]) but does not disclose the chamber includes a window such that the porous body disposed inside the chamber is visible through the window by an imaging device.
Smith further teaches wherein the chamber is at least partially transparent such that the porous body disposed inside the chamber is visible through the chamber (section 116 is open to viewing and further the cap can be translucent [0050]).
Smith provides the window in order to allowing physicians to visualize the lesion being resected ([0050]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burke with Smith in order to allow further sections of the device to be visible to imaging.
Regarding claim 13, Burke does not teach, wherein at least one of the one or more channels includes a working channel, and the window is aligned with the working channel to allow access to the working channel at the distal end of the shaft.
Smith further teaches wherein at least one of the one or more channels includes a working channel, and the window is aligned with the working channel to allow access to the working channel at the distal end of the shaft (figure 3, [0050]).
Smith provides the window in order to allowing physicians to visualize the lesion being resected ([0050]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burke with Smith in order to allow further sections of the device to be visible to imaging.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Burke (US 2021/0260335) in view of Hindmarsh (US 2019/0117857) further in view of Loske (US 2020/0360578).
Regarding claims 14-15, Burke and Hindmarsh does not disclose wherein the cap assembly includes a body with a pair of opposing halves, the body is configured to receive the distal end of the shaft and the pair of opposing halves is configured to grasp an exterior of the distal end to couple the cap assembly to the shaft (claim 14) wherein the cap assembly includes a fastener that is configured to couple the pair of opposing halves to one another, thereby securely attaching the cap assembly to the shaft (claim 15).
Loske discloses the cap assembly includes a body (10) with a pair of opposing halves (10 separated by dashed line), the body is configured to receive the distal end of the shaft and the pair of opposing halves is configured to grasp an exterior of the distal end to couple the cap assembly to the shaft (figure 6, [0092]) wherein the cap assembly includes a fastener ([0023], [0039]) that is configured to couple the pair of opposing halves to one another, thereby securely attaching the cap assembly to the shaft ([0023]).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Burke with the separable sponge of Loske in order to divide the sponge into separable units for exact placement ([0039]).
Allowable Subject Matter
Claims 3-5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach wherein, in the first position, a distal end of the tube is positioned outside the chamber such that the porous body is maintained inside the chamber and in the compressed configuration; and wherein, in the second position, the distal end of the tube is positioned inside the chamber such that the porous body is extended outside of the chamber and transitioned to the expanded configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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