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 .
Claim Objections
Claim 20 is objected to because of the following informalities: In claim 20, the phrase “the curved surface portion less than” should read “the curved surface portion is less than”. 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 10-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the claim recites “the inflation portion” in line 17. There is insufficient antecedent basis for this limitation in the claim, since an inflation portion has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the inflatable portion previously introduced.
Claims 11-17 are indefinite due to their dependencies on indefinite base claim 10.
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, 9 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fortson (US 2015/0327870 A1).
Regarding claim 1, Fortson discloses (see abstract; paras. [0030]-[0062]; figs. 1a-5b) a hemostatic device (figs. 2a-d) comprising:
a cover member (102, para. [0033]; fig. 1a) configured to cover a puncture site on a patient (figs. 1a-b);
a pressing member (includes 104 and 110, paras. [0034]-[0035]) connected to the cover member and configured to compress the puncture site (para. [0034]);
the pressing member comprising: an inflatable portion (104) configured to be inflated to an inflated state by introducing a fluid into an interior of the inflatable portion and to be deflated (paras. [0034]-[0035]); and an injection portion (110) in communication with the interior of the inflatable portion and configured to inject the fluid into the interior of the inflatable portion (para. [0035]);
the inflatable portion including a bottom surface portion (114, para. [0043]), a column portion (116, para. [0048]) extending away from the bottom surface portion (figs. 2b-d), and a curved surface portion (118) forming an upper surface of the column portion in the inflated state of the inflatable portion (para. [0048]); and
a thickness of the curved surface portion is thinner than a thickness of the column portion (para. [0048]; figs. 2b-d).
Regarding claim 9, Fortson discloses the hemostatic device according to claim 1. Fortson further discloses wherein the bottom surface portion is configured to include a long axis which passes through a center of the bottom surface portion in a lateral direction and a short axis which passes through a center of the bottom surface portion in a longitudinal direction and which is shorter than the long axis in the inflated state in which the inflatable portion is inflated (balloon may be in the shape of an oval, considered to encompass a shorter axis which is shorter than the long axis, para. [0055]), and a thickness of the inflatable portion is bilaterally symmetrical with respect to the long axis (thickness portions extend continuously, considered to be bilaterally symmetrical, figs. 2b-d).
Regarding claim 18, Fortson discloses (see abstract; paras. [0030]-[0062]; figs. 1a-5b) a hemostatic device (figs. 2a-d) for applying compression to a puncture site of a patient, the hemostatic device comprising:
a cover member (102, para. [0033]; fig. 1a) configured to be positioned in overlying relation to the puncture site on the patient (figs. 1a-b);
a pressing member (includes 104 and 110, paras. [0034]-[0035]) connected to the cover member to apply the compression to the puncture site when the cover member is positioned in overlying relation to the puncture site on the patient (figs. 1a-b), the cover member being positioned in overlying relation to the pressing member (figs. 1a-b);
the pressing member comprising an inflatable portion (104) configured to be inflated to an inflated state by introducing a fluid into an interior of the inflatable portion and to be deflated (paras. [0034]-[0035]), the pressing member also comprising an injection portion (110) in communication with the interior of the inflatable portion and configured to inject the fluid into the interior of the inflatable portion (para. [0035]);
the inflatable portion including a bottom surface portion (114, para. [0043]), a column portion (116, para. [0048]) and a curved surface portion (118);
the column portion being fixed directly to the bottom surface portion (figs. 2b-d) and extending away from the bottom surface portion when the inflatable portion is in the inflated state (figs. 2b-d), the column portion possessing a thickness (figs. 2b-d), the column portion that extends away from the bottom surface portion when the inflatable portion is in the inflated state including a part that is positioned closest to the bottom surface portion (proximal end of 116) and an end opposite the part that is closest to the bottom surface portion (distal end of 116);
the curved surface portion extending from the end of the column portion to a part of the inflatable portion that contacts the patient when the compression is applied to the puncture site (figs. 2b-d), the curved surface portion having an outer surface (outer surface of 118), at least a part of the outer surface of the curved surface portion being curved (fig. 2b), the curved surface portion having a thickness (fig. 2b); and
the thickness of at least the part of the curved surface portion that is curved being less than the thickness of the part of the column portion that is positioned closest to the bottom surface portion (para. [0048]; figs. 2b-d).
Regarding claim 19, Fortson discloses the hemostatic device according to claim 18. Fortson further discloses wherein the inflatable portion is comprised of a sheet-shaped member (114) constituting the bottom surface portion of the inflatable portion (figs. 2b-d), and a sheet member (104) constituting both the column portion and the curved surface portion (fig. 2b), the column portion being fixed directly to the bottom surface portion by virtue of a portion of the sheet member being fixed to a surface of the sheet-shaped member (fig. 2b).
Regarding claim 20, Fortson discloses the hemostatic device according to claim 18. Fortson further discloses wherein the thickness of an entirety of the curved surface portion less than the thickness of an entirety of the column portion (para. [0048]).
Allowable Subject Matter
Claims 2-8 are 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.
Claim 10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 11-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Regarding claim 2, Fortson discloses the curved surface portion includes a top surface portion (figs. 2b-d), but fails to disclose the curved surface portion further including an inclined portion that surrounds the top surface portion and is connected to the column portion, and the inclined portion including a thinned portion that surrounds the top surface portion and has a thickness less than a thickness of the top surface portion. Para. [0048] of Fortson discloses balloon 104 comprising a thicker wall portion 116 and a thinner wall portion 118, such that the thickness of balloon 104 decreases as the balloon extends distally to apply localized pressure at bubble 120 to site 106 (figs. 2b-d). Fortson does not disclose the balloon 104 further including a thinner portion between portions 116 and 118, and it would not obvious to modify the balloon of Fortson, since Fortson discloses a gradual tapering to send inflation pressure directly to bubble 120, and modification of the balloon to include a thinner walled portion as claimed would lessen the amount of targeted compressive force via inflation pressure sent directly to 118.
Regarding claim 10, Fortson discloses (see abstract; paras. [0030]-[0062]; figs. 1a-5b) a hemostatic device (figs. 2a-d) comprising: a cover member (102, para. [0033]; fig. 1a) configured to cover a puncture site on a patient (figs. 1a-b); a pressing member (includes 104 and 110, paras. [0034]-[0035]) connected to the cover member and configured to compress the puncture site (para. [0034]); the pressing member comprising: an inflatable portion (104) configured to be inflated to an inflated state by introducing a fluid into an interior of the inflatable portion and to be deflated (paras. [0034]-[0035]); and an injection portion (110) in communication with the interior of the inflatable portion and configured to inject the fluid into the interior of the inflatable portion (para. [0035]); the inflatable portion including a bottom surface portion (114, para. [0043]), a column portion (116, para. [0048]) extending away from the bottom surface portion (figs. 2b-d), and a curved surface portion (118) forming an upper surface of the column portion in the inflated state of the inflatable portion (para. [0048]); a thickness of the curved surface portion is thinner than a thickness of the column portion (para. [0048]; figs. 2b-d); the curved surface portion including a top surface portion (120) having a top portion that, in the inflated state of the inflation portion, is at a position farthest from the bottom surface portion side (fig. 2b).
However, Fortson fails to disclose the curved surface portion also including an inclined portion that is located around the top surface portion and is connected to the column portion, and the inclined portion including a thinned portion that surrounds the top surface portion and has a thickness less than a thickness of the top surface portion.
As previously discussed, para. [0048] of Fortson discloses balloon 104 comprising a thicker wall portion 116 and a thinner wall portion 118, such that the thickness of balloon 104 decreases as the balloon extends distally to apply localized pressure at bubble 120 to site 106 (figs. 2b-d). Fortson does not disclose the balloon 104 further including a thinner portion between portions 116 and 118, and it would not obvious to modify the balloon of Fortson, since Fortson discloses a gradual tapering to send inflation pressure directly to bubble 120, and modification of the balloon to include a thinner walled portion as claimed would lessen the amount of targeted compressive force via inflation pressure sent directly to 118.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2024/0423772 A1 to Forsell, disclosing a device comprising an inflatable portion with different thicknesses (fig. 8c).
US 5464420 to Hori, disclosing a device comprising a balloon with different thicknesses.
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/BRIGID K BYRD/Examiner, Art Unit 3771