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 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, 2, 7, 9-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Atthoff (US PGPub 2012/0296369).
Regarding Claim 1, Atthoff teaches a method for hemostasis after radial catheterization (Paragraph 0002 and 0011), the method comprising:
positioning a hemostasis band (compression unit; 1; Paragraph) over a radial artery puncture site of a wrist (Figure 8; Paragraph 0036);
securing the hemostasis band (1) around the wrist (Figure 8; Paragraph 0036); and
inflating a balloon (2) of the hemostasis band (1) to apply pressure over the puncture site (Paragraph 0036-0038).
Regarding Claim 2, Atthoff teaches the method of claim 1, comprising:
maintaining balloon inflation for a duration (Paragraph 0048 discloses a manometer for the pressurizing unit); and
deflating and removing the hemostasis band (inherent since the device is removable and is not intended for permanent use).
Regarding Claim 7, Atthoff teaches the method of claim 1, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3), the method further inserting the band assembly (3) into an opening (6) in a balloon assembly (2; see Figure 3; Paragraph 0039).
Regarding Claim 9, Atthoff teaches the method of claim 1, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3), the method further comprising aligning a transparent window of the balloon assembly with the puncture site (Paragraph 0044 states that the balloon is transparent and thus the surface is a transparent window).
Regarding Claim 10, Atthoff teaches the method of claim 1, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3), the method further comprising adjusting the position of the balloon assembly (2) along the band assembly (3) to optimize pressure on the puncture site (Paragraph 0039 and 0042).
Regarding Claim 11, Atthoff teaches teaches the method of claim 1, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3), the method further comprising sliding the balloon assembly (2) along one or more segments of the band assembly (3) to position the balloon assembly (2) relative to the band assembly (3; Paragraph 0039 and 0042).
Regarding Claim 12, Atthoff teaches the method of claim 1, further comprising deflating the balloon after a duration of pressure application (this step is inherent since the device is not permanent and is not intended to close the radial artery indefinitely, which would cause necrosis).
Regarding Claim 13, Atthoff teaches the method of claim 12, wherein deflation is performed passively by gradual air leakage from the balloon (see Figure 8, element 15 which is a manometer that is well known to allow gradual air leakage in devices used to measure blood pressure).
Regarding Claim 14, Atthoff teaches the method of claim 1, further comprising removing the hemostasis band from the wrist by unfastening a band assembly (see Figure 3; element 5 which is for fastening and unfastening; Paragraph 0039).
Regarding Claim 15, Atthoff teaches the method of claim 1, wherein the balloon (2) is at least substantially transparent to permit visual monitoring of the puncture site (Paragraph 0044).
Regarding Claim 16, Atthoff teaches a method for hemostasis after radial catheterization (Paragraph 0002 and 0011), the method comprising:
inserting a band assembly (3) into an opening (6) of a balloon assembly (2) (Figure 3; Paragraph 0036) to form a hemostasis band (see Figure 8; Paragraph 0036);
positioning the hemostasis band (compression unit; 1; Paragraph) over a radial artery puncture site of a wrist (Figure 8; Paragraph 0036);
securing the hemostasis band (1) around the wrist (Figure 8; Paragraph 0036); and
inflating a balloon (2) of the hemostasis band (1) to apply pressure over the puncture site (Paragraph 0036-0038).
Regarding Claim 18, Atthoff teaches the method of claim 16, further comprising removing the hemostasis band from the wrist by unfastening a band assembly (see Figure 3; element 5 which is for fastening and unfastening; Paragraph 0039).
Regarding Claim 19, Atthoff teaches a method for hemostasis after radial catheterization (Paragraph 0002 and 0011), the method comprising:
placing a hemostasis band (1) around a patient's wrist such that a balloon is aligned with a radial artery puncture site (Figure 8; Paragraph 0036);
inflating the balloon (2) to apply pressure to the puncture site (Figure 8; Paragraph 0036); and
maintaining inflation of the balloon (2) for a duration (Paragraph 0011, 0036, and 0038).
Regarding Claim 20, Atthoff teaches the method of claim 19, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3), the method further inserting the band assembly (3) into an opening (6) in a balloon assembly (2; Figure 7; Paragraph 0039).
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.
Claim(s) 3-6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atthoff (US PGPub 2012/0296369) as applied to claim 1 and 16 above, and further in view of Yamakoshi (US PGPub 2004/0010198)
Regarding Claim 3, Atthoff teaches the method of claim 1, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3) but fails to disclose the band assembly comprising first and second segments connected by a hinge.
Yamakoshi teaches a band assembly (Figures 1-8) for compressing a radial artery (Paragraph 0006), wherein the band assembly (10A) comprises first (11) and second (12) segments connected by a hinge (13; Figure 1).
It would have been obvious to one of ordinary skill in the art to Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the band assembly taught by Atthoff with the band assembly as taught by Yamakoshi since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the band assembly of Yamakoshi would be sufficient to attach the balloon assembly of Atthoff to a wrist of the user (Paragraph 0029; Yamakoshi).
Regarding Claim 4, the combination of references disclosed above teaches the method of claim 3, wherein Atthoff teaches the balloon assembly comprises a sheath (6; bladder attachment means see Figure 2 and 8), the balloon is positioned within the sheath (6; best seen in Figure 8), and the sheath includes an opening (loops) to receive the first segment (Paragraph 0042; Figures 2 and 8).
Regarding Claim 5, the combination of references disclosed above teaches the method of claim 3, wherein Yamakoshi teaches the securing step includes closing the band assembly (Paragraph 0031).
Regarding Claim 6, the combination of references disclosed above teaches the method of claim 3, wherein Yamakoshi teaches the securing step includes rotating the segments (11 and 12) about the hinge (13) to enclose the wrist (Paragraph 0030 and 0065).
Regarding Claim 17, Atthoff teaches the method of claim 16, but fails to disclose wherein the band assembly includes first and second segments connected by a hinge.
Yamakoshi teaches a band assembly (Figures 1-8) for compressing a radial artery (Paragraph 0006), wherein the band assembly (10A) comprises first (11) and second (12) segments connected by a hinge (13; Figure 1).
It would have been obvious to one of ordinary skill in the art to Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the band assembly taught by Atthoff with the band assembly as taught by Yamakoshi since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the band assembly of Yamakoshi would be sufficient to attach the balloon assembly of Atthoff to a wrist of the user (Paragraph 0029; Yamakoshi).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atthoff (US PGPub 2012/0296369) as applied to claim 1 above, and further in view of Stalemark (US PGPub 2003/0114881)
Regarding Claim 8, Atthoff teaches the method of claim 1, wherein the hemostasis band comprises a balloon assembly comprising the balloon (2; Figure 3) and a band assembly (3; Figure 3), but fails to disclose the method further comprising inflating a balloon pad on the band assembly.
Stalemark teaches a method for applying external pressure to puncture wounds following catheterization (abstract), comprising a balloon assembly (18; Figure 4; Paragraph 0019), a band assembly (17) which comprises two segments (20 and 21) connected by a hinge (22), wherein the band assembly (17) comprises a support pad (23) which is inflatable (Paragraph 0019).
It would have been obvious to one of ordinary skill in the art to modify the method of Atthoff such that the band included a pad which is inflated, as taught by Stalemark, for the advantage of so that the distance between the pressure element (balloon) and the support pad can be adjusted by expanding the support pad by means of a pneumatic device (Paragraph 0019; Stalemark).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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