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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 01/16/2026. Claims 1, 3-6 and 10 are amended. Claims 2 and 14 are cancelled. Claims 1, 3-13 and 15-18 are currently pending.
The rejection of claims 3, 5, 15 and 17 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
The rejection of claims 4 and 16 under 35 U.S.C. 112(b) has been maintained; see below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/16/2026, with respect to the rejection(s) of claim(s) 1-3, 5-6 and 10-13 under 35 U.S.C. 102(a)(1) as being anticipated by Vardi; claim 4 under 35 U.S.C. 103 as being unpatentable over Vardi in view of Weber; claims 7-9, 14-15 and 17-18 under 35 U.S.C. 103 as being unpatentable over Vardi in view of Tang; and claim 16 under 35 U.S.C. 103 as being unpatentable over Vardi in view of Weber and Tang, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
Applicant argues Vardi fails to disclose the movement of the third tube body relative to the second tube body, because Vardi instead teaches two capture shafts movable towards or away from each other, the proximal capture shaft 210 does not pass through tissue, and Vardi requires two capture mechanisms as opposed to only one capture mechanism and one tube body for controlling the grasping member to contract or expand (Remarks, pgs. 12-14).
In response to applicant’s argument, it is respectfully submitted the arguments are narrower than the claim limitations. As discussed below, an apparatus claim covers what a device is, not what it does (MPEP 2114(II)). Therefore, method steps recited in an apparatus claim are treated functionally, and the structure only needs to be capable of performing the method steps. The device of Vardi is considered to meet the claimed limitations, because shaft 190 and capture shaft 265 of Vardi are considered to be capable of moving proximally and distally and extending through tissue as claimed. Vardi discloses the distal capture mechanism constrained within housing 192 attached to the distal end of shaft 190, such that the limitation of the grasping member in a contracted state is considered to be met. The distal capture mechanism is delivered to tissue and released distally from the housing 192 as depicted in figs. 8a-13, such that the shafts are considered to be capable of moving proximally and distally through tissue to deploy the distal capture mechanism to come into contact with tissue as claimed.
Additionally, the claim limitations are open-ended, and do not preclude multiple shafts or capture mechanisms from being utilized to capture tissue, such that the claim language is considered to be met.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “grasping member” in claim 1; “puncturing member” in claim 1; “cutting member” in claim 1; “connecting part” in claim 1; “cutting part” in claim 7; “pulling part” in claim 7; “fixing part” in claim 11; “puncturing part” in claim 11.
Paras. [0059] and [0068] of the published application describe the “grasping member” as memory metal or the structure depicted in figs. 3-5. “Grasping member” uses the generic placeholder “member” coupled with the term “grasping”, which is functional in that the limitation alternatively recites a member for grasping, and the term “member” is not preceded by a structural modifier since the term “grasping” does not imply any structure.
Para. [0062] of the published application describes the “puncturing member” as including a fixing part and a puncturing part (see fig. 9). “Puncturing member” uses the generic placeholder “member” coupled with the term “puncturing”, which is functional in that the limitation alternatively recites a member for puncturing, and the term “member” is not preceded by a structural modifier since the term “puncturing” does not imply any structure.
Para. [0070] of the published application describes the “cutting member” as including a deformable cutting part. “Cutting member” uses the generic placeholder “member” coupled with the term “cutting”, which is functional in that the limitation alternatively recites a member for cutting, and the term “member” is not preceded by a structural modifier since the term “cutting” does not imply any structure.
Para. [0061] of the published application describes the “connecting part” as a hollow cylindrical structure. “Connecting part” uses the generic placeholder “part” coupled with the term “connecting”, which is functional in that the limitation alternatively recites a part for connecting, and the term “part” is not preceded by a structural modifier since the term “connecting” does not imply any structure.
Para. [0074] of the published application describes the “cutting part” as a combination of two opposite C-shaped rings. “Cutting part” uses the generic placeholder “part” coupled with the term “cutting”, which is functional in that the limitation alternatively recites a part for cutting, and the term “part” is not preceded by a structural modifier since the term “cutting” does not imply any structure.
Figure 8 of the instant spec. depicts the “pulling part”. “Pulling part” uses the generic placeholder “part” coupled with the term “pulling”, which is functional in that the limitation alternatively recites a part for pulling, and the term “part” is not preceded by a structural modifier since the term “pulling” does not imply any structure.
Figure 9 of the instant spec. depicts the “fixing part”. “Fixing part” uses the generic placeholder “part” coupled with the term “fixing”, which is functional in that the limitation alternatively recites a part for fixing, and the term “part” is not preceded by a structural modifier since the term “fixing” does not imply any structure.
Para. [0062] of the published application describes the “puncturing part” as a structure hemispherical in shape. “Puncturing part” uses the generic placeholder “part” coupled with the term “puncturing”, which is functional in that the limitation alternatively recites a part for puncturing, and the term “part” is not preceded by a structural modifier since the term “puncturing” does not imply any structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 4 and 16 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.
Regarding claim 4, the claim recites “the deformation part” in lines 2, 4 and 6. It is unclear whether the phrase is referring to the multiple deformation parts previously introduced, or at least one of the multiple deformation parts previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least one of the multiple deformation parts previously introduced.
Claim 16 is indefinite due to its dependency on indefinite base claim 4.
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(s) 1, 3, 5-6 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vardi (US 2020/0170662 A1) (all references previously of record).
Regarding claim 1, Vardi discloses (see abstract; paras. [0090]-[0182]; figs. 1-22b) a stoma instrument (fig. 1), comprising:
a first tube body (outer cutter shaft 130, para. [0091]; fig. 2), wherein one end of the first tube body (distal end of outer cutter shaft 130) is provided with a receiving opening for receiving a biological tissue (distal opening of lumen of outer cutter shaft 130, fig. 5);
a second tube body (inner cutter shaft 190, para. [0093]; fig. 5), wherein the second tube body is moveably arranged inside the first tube body (para. [0095]);
a third tube body (first capture shaft 265, para. [0108]; fig. 5), wherein the third tube body is moveably arranged inside the second tube body (para. [0110]);
a grasping member (distal capture mechanism 250, para. [0102]; fig. 5), wherein the grasping member is connected to one end of the third tube body (distal end of first capture shaft 265, para. [0109]) close to the receiving opening (considered to be close as depicted in fig. 5), the grasping member is used for radially contracting into the second tube body after deformation to follow the second tube body to pass through the biological tissue (pulled into tissue capture housing which is attached to shaft 190, para. [0119]; figs. 10-13), and for radially expanding and moving towards the first tube body to grasp the biological tissue into the receiving opening after the grasping member passes through the biological tissue and leaves the second tube body (captures tissue volume as it’s compressed proximally and moved towards opening of shaft 130, para. [0120]; figs. 10-13);
a puncturing member (annotated fig. 5), wherein the puncturing member is connected to one end of the grasping member away from the third tube body (distal end is considered to be end away from shaft 265), and the puncturing member is located at the end of the second tube body (considered to be located at distal end of 190 since tip is distal of distal end of 190, fig. 5) to guide the second tube body to pass through the biological tissue (considered to guide the device through tissue); and
a cutting member (sharp edge 150, para. [0092]; fig. 2), wherein the cutting member is used for cutting the biological tissue received at the receiving opening (abstract, para. [0093]);
wherein the grasping member comprises a first connecting part (annotated fig. 9) connected to the third tube body (considered to be connected to shaft 265 at distal end), a second connecting part (annotated fig. 9) connected to the puncturing member (considered to be connected via capture mechanism 250), and multiple deformation parts (includes central struts of capture mechanism 250) connecting the first connecting part and the second connecting part (fig. 9), wherein the first connecting part and the second connecting part extend along the axial direction of the third tube body (fig. 9), the multiple deformation parts are arranged around the central axis of the third tube body (fig. 9);
the grasping member is normally in an expanded state (formed of nitinol and easily expandable to nominally open shape, considered to encompass a normal expanded state, para. [0113]);
the second tube body has a distal end located in the receiving opening (fig. 5), and before stoma, the third tube body is moved backwards relative to the second tube body such that the multiple deformation parts are squeezed to deform by the inner wall of the distal end of the second tube body to cause the grasping member to turn into a contracted state and be received in the distal end of the second tube body (distal capture mechanism 250 held in constrained state within housing 192 at distal end of 190, see also figs. 8a-c depicting movement of 250 within and out of housing 192, such that shaft 265 is considered to be capable of moving proximally and distally to constrain/expand 250 relative to 192, note this limitation recites method steps in an apparatus claim and is therefore treated functionally, because an apparatus claim covers what a device is, not what it does, see MPEP 2114(II), paras. [0110]-[0112]);
during stoma (considered to be during use), the second tube body is moved forwards such that the distal end of the second tube body with the grasping member being received therein passes through the biological tissue by using the puncturing member to puncture the biological tissue (holds distal capture mechanism in constrained posture during crossing of tissue, considered to be capable of passing through biological tissue distally as claimed, since this limitation recites method steps in an apparatus claim and is therefore treated functionally, para. [0111], figs. 8a-13), and the second tube body is then moved backwards relative to the third tube body (considered to be capable of moving proximally and distally, figs. 8a-13) such that the grasping member is released out of the distal end of the second tube body and automatically returns to the expanded state (figs. 8a-13), causing the grasping member to come into contact with the biological tissue for pushing the biological tissue towards the receiving opening (via proximal movement, depicted in figs. 8a-13).
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Annotated Figure 5 of Vardi
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Annotated Figure 9 of Vardi
Regarding claim 3, Vardi discloses the stoma instrument in claim 1. Vardi further discloses wherein each of the multiple deformation parts is provided with a hook (barbs, para. [0118]) for grasping the biological tissue.
Regarding claim 5, Vardi discloses the stoma instrument in claim 1. Vardi further discloses wherein each of the multiple deformation parts is C-shaped (straight and angled sections of capture mechanism considered to form a C-shape, which appears to be consistent with figs. 3-5 of the instant spec., figs. 8c-9 of Vardi), and two ends of each of the multiple deformation parts are connected to the first connecting part and the second connecting part, respectively (proximal and distal ends of straight section connected to angled sections, figs. 8c-9).
Regarding claim 6, Vardi discloses the stoma instrument in claim 1. Vardi further discloses wherein the grasping member is a memory metal (formed of nitinol, para. [0113]).
Regarding claim 10, Vardi discloses the stoma instrument in claim 1. Vardi further discloses wherein the first tube body comprises an extension part (portion proximal of cutter 140, fig. 2) and a stoma part (cutter 140, fig. 2) both of which are extended axially (figs. 2 and 5), the center portion of the extension part is provided with an active channel (lumen of 130) arranged around the central axis of the first tube body (fig. 2) and having a smaller diameter than the first tube body (threaded portions of 130 considered to form a smaller diameter than other portions of 130, para. [0093]) for the second tube body to pass through (fig. 5) and multiple cavities (threaded portion of 140, which may be incorporated on outer shaft assembly, paras. [0093]-[0094]) arranged around the active channel (figs. 2-3), and one end of the stoma part away from the extension part has the receiving opening (fig. 5), one end of the stoma part close to the extension part is provided with multiple protrusions corresponding to the cavities (corresponding portion of threaded assembly 160, considered to be protrusions, paras. [0093]-[0094]), and the protrusions are embedded and fixed in the cavities (considered to be embedded and fixed when threaded).
Regarding claim 11, Vardi discloses the stoma instrument in claim 1. Vardi further discloses wherein the puncturing member comprises a fixing part (annotated fig. 5) fixedly connected to the grasping member and a puncturing part (distal tip, annotated fig. 5) for puncturing the biological tissue, and the puncturing part is hemispherical in shape (fig. 5).
Regarding claim 12, Vardi discloses the stoma instrument in claim 1. Vardi further discloses wherein the stoma instrument further comprises a control handle (includes 120 and 220, paras. [0090]-[0091] and [0135]; fig. 1) fixedly connected at one end of the first tube body away from the receiving opening (fig. 1), the second tube body and the third tube body are both connected to the control handle (para. [0136]), and the control handle is used to control the axial movement of the second tube body and the third tube body (controls movement of proximal and distal capture shafts, para. [0137]).
Regarding claim 13, Vardi discloses (see abstract; paras. [0090]-[0182]; figs. 1-22b) a stoma method using the stoma instrument in claim 1. Vardi further discloses wherein the stoma method comprises:
before stoma, the third tube body is moved, so that the grasping member is received in the second tube body, and the puncturing member is located at the end of the second tube body (shaft 265 is moved to open and close distal capture mechanism, depicted as constrained in figs. 8a-b);
next, the second tube body is driven to move, and the grasping member and the puncturing member move with the second tube body (catheter advanced to deploy distal capture mechanism, considered to encompass movement of 190, para. [0097]), the puncturing member located at the end comes into contact with and punctures the biological tissue (distal tip crosses atrial septum, para. [0056]), so that the grasping member passes through the biological tissue, but the first tube body does not pass through the biological tissue (para. [0062]; figs. 10-11);
thereafter, the second tube body is driven to move relative to the third tube body in a direction away from the puncturing member (distal capture mechanism fully deployed outside of capture housing 192, considered to encompass proximal movement of 192, paras. [0066] and [0112]; figs. 8a-b), and the grasping member deforms and expands radially after leaving the second tube body, resulting in an increase of its radial area (depicted in figs. 8a-13);
then, the second tube body and the third tube body are driven to move as a whole towards the first tube body, the grasping member comes into contact with the biological tissue and pushes the biological tissue to the receiving opening (pulled into tissue capture housing after contacting tissue, para. [0066]; figs. 10-13); and
finally, the cutting member operates to separate the biological tissue inside the receiving opening from the biological tissue outside the receiving opening (para. [0074]).
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.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Vardi in view of Weber (US 2004/0122457 A1).
Regarding claim 4, Vardi discloses the stoma instrument in claim 3.
Vardi further discloses wherein one end of the deformation part close to the first connecting part is provided with a contacting surface for contacting the biological tissue (center surfaces of capture mechanism including hook, para. [0146]), and the contacting surface is provided with the hook (para. [0146]).
However, Vardi fails to disclose a cutout corresponding to the hook, when the deformation part contracts, the hook is received in the cutout.
Weber teaches (paras. [0049]-[0055]; figs. 2-4), in the same field of endeavor, a medical cutting device comprising a cutout (32) corresponding to a hook (20), when a deformation part contracts (18), the hook is received in the cutout (figs. 2-4), for the purpose of providing a structure that allows the blades to retract within the housing when the cutting unit is in its non-cutting configuration (para. [0055]).
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 deformation part of Vardi to include a housing comprising cutouts corresponding to the hooks, in order to provide a non-cutting configuration of the distal capture mechanism in the expanded orientation, such as for repositioning of the distal capture mechanism or protection from cutting unnecessary tissue, based on the suggestions and teachings of Weber (para. [0055]).
Claim(s) 7-9, 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vardi in view of Tang (CN 109259853 A, translation attached).
Regarding claim 7, Vardi discloses the stoma instrument in claim 1.
However, Vardi fails to disclose wherein the cutting member comprises a deformable cutting part disposed around the receiving opening, a first pulling part that is moveably arranged inside the first tube body, and a second pulling part that is moveably arranged inside the first tube body, the second pulling part is used to tension the cutting part for cutting the biological tissue.
Tang teaches (pgs. 1-9), in the same field of endeavor, a stoma instrument (abstract), comprising a cutting member (cutting portion 21) comprising a deformable cutting part (cutting ring 210) disposed around a receiving opening (fig. 2), a first pulling part (2122) that is moveably arranged inside a first tube body (via second tube wall cavity 113, pg. 4), and a second pulling part (2112) that is moveably arranged inside the first tube body (via first tube wall cavity 112), the second pulling part is used to tension the cutting part for cutting the biological tissue (pulled to deform cutting ring 210 and cut tissue, pg. 8), for the purpose of providing a deformable wire which allows for repositioning of the cutting wire relative to the tissue when desired (pg. 8).
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 cutter of Vardi to be a deformable cutting wire pulled into channels of the outer shaft 130, in order to provide the capability of repositioning the cutter relative to the outer shaft, providing a more accurate cut of the tissue when desired, based on the suggestions and teachings of Tang (pg. 8).
Regarding claim 8, Vardi (as modified) teaches the stoma instrument in claim 7. Vardi (as modified) further teaches wherein the first tube body is provided with two pulling channels (112 and 113 of Tang, fig. 3) that penetrate axially through the first tube body (fig. 3 of Tang), and the first pulling part and the second pulling part are respectively arranged in the two pulling channels (fig. 2 of Tang).
Regarding claim 9, Vardi (as modified) teaches the stoma instrument in claim 7. Vardi (as modified) further teaches wherein the cutting part is a combination of two opposite C-shaped rings (fig. 4 of Tang).
Regarding claim 15, Vardi discloses the stoma instrument in claim 3.
However, Vardi fails to disclose wherein the cutting member comprises a deformable cutting part disposed around the receiving opening, a first pulling part that is moveably arranged inside the first tube body, and a second pulling part that is moveably arranged inside the first tube body, the second pulling part is used to tension the cutting part for cutting the biological tissue.
Tang teaches (pgs. 1-9), in the same field of endeavor, a stoma instrument (abstract), comprising a cutting member (cutting portion 21) comprising a deformable cutting part (cutting ring 210) disposed around a receiving opening (fig. 2), a first pulling part (2122) that is moveably arranged inside a first tube body (via second tube wall cavity 113, pg. 4), and a second pulling part (2112) that is moveably arranged inside the first tube body (via first tube wall cavity 112), the second pulling part is used to tension the cutting part for cutting the biological tissue (pulled to deform cutting ring 210 and cut tissue, pg. 8), for the purpose of providing a deformable wire which allows for repositioning of the cutting wire relative to the tissue when desired (pg. 8).
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 cutter of Vardi to be a deformable cutting wire pulled into channels of the outer shaft 130, in order to provide the capability of repositioning the cutter relative to the outer shaft, providing a more accurate cut of the tissue when desired, based on the suggestions and teachings of Tang (pg. 8).
Regarding claim 17, Vardi discloses the stoma instrument in claim 5.
However, Vardi fails to disclose wherein the cutting member comprises a deformable cutting part disposed around the receiving opening, a first pulling part that is moveably arranged inside the first tube body, and a second pulling part that is moveably arranged inside the first tube body, the second pulling part is used to tension the cutting part for cutting the biological tissue.
Tang teaches (pgs. 1-9), in the same field of endeavor, a stoma instrument (abstract), comprising a cutting member (cutting portion 21) comprising a deformable cutting part (cutting ring 210) disposed around a receiving opening (fig. 2), a first pulling part (2122) that is moveably arranged inside a first tube body (via second tube wall cavity 113, pg. 4), and a second pulling part (2112) that is moveably arranged inside the first tube body (via first tube wall cavity 112), the second pulling part is used to tension the cutting part for cutting the biological tissue (pulled to deform cutting ring 210 and cut tissue, pg. 8), for the purpose of providing a deformable wire which allows for repositioning of the cutting wire relative to the tissue when desired (pg. 8).
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 cutter of Vardi to be a deformable cutting wire pulled into channels of the outer shaft 130, in order to provide the capability of repositioning the cutter relative to the outer shaft, providing a more accurate cut of the tissue when desired, based on the suggestions and teachings of Tang (pg. 8).
Regarding claim 18, Vardi discloses the stoma instrument in claim 6.
However, Vardi fails to disclose wherein the cutting member comprises a deformable cutting part disposed around the receiving opening, a first pulling part that is moveably arranged inside the first tube body, and a second pulling part that is moveably arranged inside the first tube body, the second pulling part is used to tension the cutting part for cutting the biological tissue.
Tang teaches (pgs. 1-9), in the same field of endeavor, a stoma instrument (abstract), comprising a cutting member (cutting portion 21) comprising a deformable cutting part (cutting ring 210) disposed around a receiving opening (fig. 2), a first pulling part (2122) that is moveably arranged inside a first tube body (via second tube wall cavity 113, pg. 4), and a second pulling part (2112) that is moveably arranged inside the first tube body (via first tube wall cavity 112), the second pulling part is used to tension the cutting part for cutting the biological tissue (pulled to deform cutting ring 210 and cut tissue, pg. 8), for the purpose of providing a deformable wire which allows for repositioning of the cutting wire relative to the tissue when desired (pg. 8).
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 cutter of Vardi to be a deformable cutting wire pulled into channels of the outer shaft 130, in order to provide the capability of repositioning the cutter relative to the outer shaft, providing a more accurate cut of the tissue when desired, based on the suggestions and teachings of Tang (pg. 8).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Vardi in view of Weber as applied to claim 4 above, and further in view of Tang.
Regarding claim 16, Vardi (as modified) teaches the stoma instrument in claim 4.
However, Vardi (as modified) fails to teach wherein the cutting member comprises a deformable cutting part disposed around the receiving opening, a first pulling part that is moveably arranged inside the first tube body, and a second pulling part that is moveably arranged inside the first tube body, the second pulling part is used to tension the cutting part for cutting the biological tissue.
Tang teaches (pgs. 1-9), in the same field of endeavor, a stoma instrument (abstract), comprising a cutting member (cutting portion 21) comprising a deformable cutting part (cutting ring 210) disposed around a receiving opening (fig. 2), a first pulling part (2122) that is moveably arranged inside a first tube body (via second tube wall cavity 113, pg. 4), and a second pulling part (2112) that is moveably arranged inside the first tube body (via first tube wall cavity 112), the second pulling part is used to tension the cutting part for cutting the biological tissue (pulled to deform cutting ring 210 and cut tissue, pg. 8), for the purpose of providing a deformable wire which allows for repositioning of the cutting wire relative to the tissue when desired (pg. 8).
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 cutter of Vardi (as modified) to be a deformable cutting wire pulled into channels of the outer shaft 130, in order to provide the capability of repositioning the cutter relative to the outer shaft, providing a more accurate cut of the tissue when desired, based on the suggestions and teachings of Tang (pg. 8).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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