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 .
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.
Claim Objections
Claims 9 and 19 are objected to because of the following informalities: "is provide" should be "is provided.” Appropriate correction is required.
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 1-19 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.
The term “substantially” in claims 1, 8, 9, and 19 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what degree is necessary for substantially parallel or perpendicular.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takahashi (WO 2019/189079).
Regarding claim 1, Takahashi teaches a medical device comprising:
an expansion body configured to be expandable and contractible in a radial direction (21 as in Fig. 8);
an elongated shaft (30), the elongated shaft includes a distal end part including a proximal end fixing portion to which a proximal end of the expansion body is fixed (distal end part as 31 to which a proximal portion of 21 is fixed);
an electrode portion provided along the expansion body (22);
the expansion body including a recess that is recessed radially inward during expansion of the expansion body and defines a reception space configured to receive a biological tissue (space between 52 and 53 to receive biological tissue as in at least Fig. 8);
the recess including a bottom portion located on an innermost side in the radial direction (bottom portion between 52 and 53 as the bottom of the u shape as in Fig. 8), a proximal-side upright portion extending outward in the radial direction from a proximal end of the bottom portion (52), and a distal-side upright portion extending outward in the radial direction from a distal end of the bottom portion (53);
one of the proximal-side upright portion and the distal-side upright portion is provide with the electrode portion (Fig. 8, 11);
another of the proximal-side upright portion and the distal-side upright portion is provided with an outer peripheral portion that is bifurcated from a vicinity of the bottom portion and extends outward in the radial direction (Fig. 11, outer distal side arm portions 65 are bifurcated), a back support portion that is disposed inside the outer peripheral portion and includes a receiving surface facing the electrode portion when the expansion body expands (radially inward portion of 65), and an arm portion extending from the back support portion or from the outer peripheral portion (radially outward portion of 65);
the receiving surface of the back support portion is configured to be inclined and substantially parallel to the electrode portion via the biological tissue clamped between the electrode portion and the back support portion when the electrode portion moves toward the back support portion (Fig. 11, pack portion is substantially parallel to 22 and inclined as in at least par. [0035]); and
the arm portion includes one of:
i) extending from the back support portion, while curving or bending (radially outward portion of 65 bends as in at least Fig. 10), to be connected to the outer peripheral portion (connects to outer peripheral portion), and being deformed to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (bends to set the inclination depending on the amount of material of 65).
Regarding claim 2, Takahashi teaches wherein the back support portion extends outward in the radial direction in a plate shape from the outer peripheral portion near the bottom portion (65 is plate shaped as in at least Fig. 11).
Regarding claim 3, Takahashi teaches wherein the arm portion is bifurcated from a radially outer end of the back support portion (radially outward portion of 65 is split as in Fig. 11), and extends symmetrically about an extending direction of the back support portion, while curving or bending, to be connected to the outer peripheral portion (par. [0069]), the arm portion being deformed to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 4, Takahashi teaches wherein the arm portion extends from a radially outer end of the back support portion (radially outer end of 65 with arm extending out), and comes into contact with the outer peripheral portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (65 is connected to the outer peripheral portion).
Regarding claim 5, Takahashi teaches wherein the outer peripheral portion includes a merging portion at which merging occurs at an end opposite to the bottom portion (par. [0069] merging point at 105);
the expansion body includes an extension portion extending radially inward from the merging portion of the outer peripheral portion (64 with a portion that extends radially inward from the merging portion of the outer peripheral portion as in Fig. 11); and
the arm portion extends from a radially outer end of the back support portion (arm portion 65 extends from radially outer end of radially inward portion of 65), and comes into contact with an inner surface of the extension portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 6, Takahashi teaches wherein the arm portion extends to connect bifurcated parts of the outer peripheral portion (bifurcated peripheral portions 104 as in at least par. [0069]), and comes into contact with a surface of the back support portion opposite to a surface facing the electrode portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 7, Takahashi teaches wherein the outer peripheral portion includes a merging portion at which merging occurs at an end opposite to the bottom portion (par. [0069] merging point at 105); and
the arm portion extends toward the back support portion from the merging portion of the outer peripheral portion (64 extends toward radially inward portion of 65), and comes into contact with a surface of the back support portion opposite to a surface facing the electrode portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 8, Takahashi teaches wherein the back support portion includes a plurality of rods extending substantially perpendicular to a radial direction of the expansion body (64) and substantially parallel to a surface of the electrode portion facing the recess (64 roughly parallel with surface of electrode portion), the plurality of rods being disposed substantially parallel to each other (64 parallel to each other as in at least Fig. 10);
the arm portion includes a plurality of connecting arm portions that connect both ends of the plurality of rods and the outer peripheral portion so as to form a U-shape open toward the bottom portion together with the plurality of rods (64 with U-shape as in Fig. 11);
the receiving surface of the back support portion is defined by a virtual plane including at least a part of each of the plurality of rods (rods 64 as part of a plane facing radially outward to help define the back support portion); and
each of the plurality of connecting arm portions rotates about a connection portion with the outer peripheral portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 9, Takahashi teaches a medical device comprising:
an expansion body configured to be expandable and contractible in a radial direction (21 as in Fig. 8);
an elongated shaft (30), the elongated shaft includes a distal end part including a proximal end fixing portion to which a proximal end of the expansion body is fixed (distal end part as 31 to which a proximal portion of 21 is fixed);
an electrode portion provided along the expansion body (22), the expansion body including a recess that is recessed radially inward during expansion of the expansion body and defines a reception space configured to receive a biological tissue (space between 52 and 53 to receive biological tissue as in at least Fig. 8);
the recess including a bottom portion located on an innermost side in the radial direction (bottom portion between 52 and 53 as the bottom of the u shape as in Fig. 8), a proximal-side upright portion extending outward in the radial direction from a proximal end of the bottom portion (52), and a distal-side upright portion extending outward in the radial direction from a distal end of the bottom portion (53);one of the proximal-side upright portion and the distal-side upright portion is provide with the electrode portion (portion connected to 22);
an other of the proximal-side upright portion and the distal-side upright portion is provided with an outer peripheral portion that is bifurcated from a vicinity of the bottom portion and extends outward in the radial direction (Fig. 11, outer distal side arm portions 65), a back support portion that is disposed inside the outer peripheral portion and includes a receiving surface facing the electrode portion when the expansion body expands (radially inward portion of 65), and an arm portion extending from the back support portion or from the outer peripheral portion (radially outward portion of 65); and
the receiving surface of the back support portion is configured to be inclined and substantially parallel to the electrode portion via the biological tissue clamped between the electrode portion and the back support portion when the electrode portion moves toward the back support portion (Fig. 11, pack portion is substantially parallel to 22 and inclined as in at least par. [0035]).
Regarding claim 10, Takahashi teaches wherein the arm portion extends from the back support portion, while curving or bending, to be connected to the outer peripheral portion (par. [0069]), and being deformed to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 11, Takahashi teaches wherein the arm portion extends from the back support portion (radially outer end of 65 with arm extending out), and coming into contact with the outer peripheral portion or a part of the expansion body to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 12, Takahashi teaches wherein the arm portion extends from the outer peripheral portion (arm extends from outer distal side arm portions 65), and coming into contact with the back support portion to limit an inclination amount of the back support portion when the receiving surface of the back support portion is inclined (par. [0035], Fig. 11).
Regarding claim 13, Takashi teaches wherein the arm portion connect the back support portion and the outer peripheral portion so as to form a U-shape open toward the bottom portion together with the back support portion (64 with U-shape as in Fig. 11), and rotating about a connection portion with the outer peripheral portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (Par. [0035]).
Regarding claim 14, Takahashi teaches wherein the back support portion extends outward in the radial direction in a plate shape from the outer peripheral portion near the bottom portion (65 is plate shaped as in at least Fig. 11).
Regarding claim 15, Takahashi teaches wherein the arm portion is bifurcated from a radially outer end of the back support portion (radially outward portion of 65 is split as in Fig. 11), and extends symmetrically about an extending direction of the back support portion, while curving or bending, to be connected to the outer peripheral portion (par. [0069]), the arm portion being deformed to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 16, Takahashi teaches wherein the arm portion extends from a radially outer end of the back support portion (radially outer end of 65 with arm extending out), and comes into contact with the outer peripheral portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (65 is connected to the outer peripheral portion).
Regarding claim 17, Takahashi teaches wherein the outer peripheral portion includes a merging portion at which merging occurs at an end opposite to the bottom portion (par. [0069] merging point at 105);
the expansion body includes an extension portion extending radially inward from the merging portion of the outer peripheral portion (64 with a portion that extends radially inward from the merging portion of the outer peripheral portion as in Fig. 11); and the arm portion extends from a radially outer end of the back support portion (arm portion 65 extends from radially outer end of radially inward portion of 65), and comes into contact with an inner surface of the extension portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035] and Fig. 11).
Regarding claim 18, Takahashi teaches wherein the arm portion extends to connect bifurcated parts of the outer peripheral portion (bifurcated peripheral portions 104 as in at least par. [0069]), and comes into contact with a surface of the back support portion opposite to a surface facing the electrode portion to limit an inclination amount of the receiving surface of the back support portion when the receiving surface is inclined (par. [0035]).
Regarding claim 19, Takahashi teaches a medical device (10) comprising:
an expansion body configured to be expandable and contractible in a radial direction (21 expands and contracts as in at least par. [0073]);
an electrode portion provided along the expansion body (22), the expansion body including a recess that is recessed radially inward during expansion of the expansion body (recess to hold tissue between as in Fig. 9);
the recess including a bottom portion located on an innermost side in the radial direction (u shape portion between 52 and 53), a proximal-side upright portion extending outward in the radial direction from a proximal end of the bottom portion (52), and a distal-side upright portion extending outward in the radial direction from a distal end of the bottom portion (53);
one of the proximal-side upright portion and the distal-side upright portion is provide with the electrode portion (22 on 52);
an other of the proximal-side upright portion and the distal-side upright portion is provided with an outer peripheral portion that is bifurcated from a vicinity of the bottom portion and extends outward in the radial direction (Fig. 11, outer distal side arm portions 65 are bifurcated), a back support portion that is disposed inside the outer peripheral portion and includes a receiving surface facing the electrode portion when the expansion body expands (radially inward portion of 65), and an arm portion extending from the back support portion or from the outer peripheral portion (radially outward portion of 65); and
the receiving surface of the back support portion is configured to be inclined and substantially parallel to the electrode portion via an object clamped between the electrode portion and the back support portion when the electrode portion moves toward the back support portion (Fig. 9, with electrode 22and back support parallel and inclined via the tissue clamped between).
Regarding claim 20, Takahashi teaches a treatment method comprising:
forming a puncture hole in an atrial septum of a patient (par. [0056]);
delivering the medical device according to claim 1 to a vicinity of the atrial septum (see claim 1 above, delivered as in par. [0054]);increasing the expansion body in diameter (par. [0058]), and locating the recess in the puncture hole of the atrial septum and receiving the biological tissue surrounding the puncture hole in the reception space (par. [0058]);
clamping the atrial septum between the proximal-side upright portion and the distal-side upright portion (Fig. 9); and
cauterizing the biological tissue by applying a voltage to the electrode portion (par. [0061]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baker (US 5,957,920) teaches grasping tissue between two expanding elements. Chanduszko (US 2005/0043759) teaches grasping heart tissue between expanding elements with bifurcating and merging sections.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794