DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 31 October 2025.
Notice of 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 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.
Response to Arguments
In the response filed 31 October 2025, claims 1 and 15 were amended to recite the inflatable member is disposed on the support member “in a fixed position” because CN’641’s pressing element 30 (mapped to the claimed “inflatable element”) is rotatable relative to the support member 31, as discussed in paragraph [0024].
This argument is not persuasive because, although Examiner agrees the pressing element 30 rotates relative to the support member 31, the position of the pressing element is fixed. Put another way, the pressing element is not changing position relative to the support member because it is rotating in a single location. In order to differentiate over this rotation, Examiner suggests deleting the term “position” from the claim – i.e. the pressing member is fixed relative to the support member rather than “in a fixed position”.
In order to advance prosecution, Examiner interpreted the claims as intended by Applicant – where the pressing element is fixed relative to the support member – and addressed this limitation in the rejection.
Applicant argues that modifying CN’641 such that the pressing element is fixed relative to the support member, as in Kiemeneij’602, would change its principle of operation. This argument is not persuasive because CN’641 will still function to stop bleeding at a puncture site if the pressing element is fixed or rotatable relative to the support member. MPEP 2145 states “a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed." In this case, although CN’641 teaches the pressing element rotates relative to the support member, it does not criticize or discourage the use of a fixed pressing element.
Although CN’641 teaches the pressing element is rotatable relative to the support member, Examiner maintains it would be obvious to modify CN’641 to have a fixed/non-rotatable pressing element, as taught by Kiemeneij’602. See the updated rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 4, 6, 7, 9, 12, 14-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over CN 207666641 (hereafter CN’641) in view of Kiemeneij et al. (US Patent 2019/0133602).
Note: Translation for CN’641 and CN’510 is attached and copied from Espacenet. Paragraph numbers were added manually by examiner and do not correspond to the paragraphs on the Chinese patent. No copy of the Chinese version of CN’641 is attached because Applicant provided a copy with the 2/17/2023 IDS. A copy of the Chinese version of CN’510 is attached.
Claims 1, 12: CN’641 teaches a hemostatic device (paragraph [0003]) comprising:
a pressing member (3) configured to compress a patient's puncture site (paragraph [0025]);
a first band body (1) configured to be connectable to the pressing member (3) and configured to be rotatable about a first rotation axis (paragraph [0022] and Figure 3 shows the first band body 1 is placed over and rotatably disposed about the pressing member 3), the first band body (1) including a portion configured to be connectable to the pressing member (1 is connected to the pressing member in its center) and a free first end portion (left side of band 1 in Figure 1 with respect to the page);
a second band body (2) configured to be connectable to the pressing member and configured to be rotatable about a second rotation axis (paragraph [0022] and Figure 3 shows the second band body 2 is placed over and rotatably disposed about the pressing member 3), the second band body (2) including center) and a free second other end portion (top of band 2 in Figure 1 with respect to the page);
the pressing member (3) includes a support member (31) and a protruding portion (33) fixed to one surface of the support member (i.e the top surface, with respect to the page) and protruding in a direction away from the support member, and the support member has a pressing element (30) positioned in a fixed location on another surface positioned on a side opposite to the one surface of the support member (i.e. the bottom surface, with respect to the page) (Figure 3); and
each one of the first and second band bodies (1, 2) are connected to the protruding portion in a state of being rotatable with respect to the pressing member (paragraph [0022]).
CN’641 teaches the first and second bands each have two free ends on opposite sides of the pressing member. Therefore CN’641 does not teach a third band.
Like CN’641, Kiemeneij’602 teaches a hemostatic device for use on a vascular puncture (paragraph [0002]).
Kiemeneij’602 teaches a pressing member (140), a first band body (110), a second band body (120) and a third band body (130).
The first band body (110) has a first one end portion (111) connected to the pressing member and a free first end portion (112). The second band body (120) has a second one end portion (121) connected to the pressing member and a free second other end portion (122). The third band body (130) has a third one end portion (131) connected to the pressing member and a free third other end portion (132).
Kiemeneij’602 further teaches the first, second and third band bodies (110, 120, 130) are rotatable about a rotation axis (central axis going into the page in Figure 1) in order to adjust the angles (α, β, χ) in order to match or conform to the anatomy characteristics of a particular patient (paragraphs [0025], [0028], [0031]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 such that there are three bands each having one end connected to the pressing member and an opposite free end, such that the three bands are each rotatable about a rotation axis, as taught by Kiemeneij’602, in order to conform and match the anatomy characteristics in a patient and to provide hemostasis in the wrist and foot (paragraph [0002]).
CN’641 teaches the support member includes a mechanical pressing element (30) and therefore does not teach the support member has an inflatable member. CN’641 does not teach the pressing element is fixed to the support member.
Kiemeneij’602 teaches a pressing member (140) can be in the form of a mechanical compression device (paragraph [0034]), as in CN’641, or, alternately, it can be an inflatable member (145) positioned on a support member 144. The inflatable member (145) is fixed to the support member (144) (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 by substituting a mechanical pressing element (30) with an inflatable member, as taught by Kiemeneij’602, because the substitution of one known element (i.e. a mechanical pressing element) for another (i.e. an inflatable member) would create predictable results. Specifically, Kiemeneij’602 teaches that both mechanical pressing elements and inflatable elements both achieve the same effect of applying pressure to a puncture wound to stop bleeding. The inflatable pressing device has the ability to more gradually increase pressure (e.g. by slowly inflating the chamber) in order to be more comfortable to the patient. It would be obvious to modify CN’641’s mechanical pressing element with an inflatable chamber, as taught by Kiemeneij’602, in order to provide this advantage.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 in which the pressing element is rotatably connected to the support plate, to a configuration in which the pressing element is fixed to the support plate, as in Kiemeneij’602, because the substitution of one connection mechanism (rotatable connection) for another (fixed connection) would yield the predictable result of applying pressure to stop bleeding at a puncture site. One of ordinary skill in the art would expect a hemostatic device with a movable connection between the support plate and the pressing element or a fixed connection between the support plate and the pressing element to perform equally well at stopping blood flow regardless of the connection because after the hemostatic device is applied to the patient, the pressing member does not move. A non-rotatable pressing element would be advantageous because it would allow the surgeon to have more control over the hemostatic device when attaching it to the body.
Claim 3: In CN’641, the protruding portion (33) is disposed at a position overlapping with the mechanical pressing element (30) in a plane direction of the support member (Figure 3).
In the resulting device of CN’641 in view of Kiemeneij’602, CN’641’s mechanical pressing element (30) is replaced with an inflatable bladder. Since the mechanical pressing element is disposed at a position overlapping with the protruding portion (33), it would be obvious that the substituted inflatable member would be in the same position and therefore also disposed at a position overlapping with the protruding portion (33).
Claim 4: Kiemeneij’602’s inflatable member (145) is considered to be connectable and separable from the support member 144 since it is connected during manufacture and it can be separated from the support member at least by cutting it off.
Claim 6: CN’641 teaches the protruding portion (33) has a recessed portion (indentation between 32 and 33 in Figure 3).
Claim 7: CN’641 does not teach the recessed portion of the protruding portion is transparent.
Kiemeneij’602 teaches providing the pressing member with a transparent portion in order to allow the puncture site to be visualized during placement of the compression member (paragraph [0035]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 by providing the recessed portion with a transparent region, as taught by Kiemeneij’602, in order to allow the puncture to be viewed during placement of the compression member.
Claim 9: CN’641 teaches the first band body (1) and second band body (2) are connectable to the protruding portion (130) so as to overlap in a height direction of the protruding portion (Figure 3).
Claim 14: CN’641 teaches providing the first and second bands with fixing members (10; 20, 21; paragraph [0023]).
Kiemeneij’602 teaches providing the first, second and third bands with fixing members (paragraph [0023]).
Claim 15, 17: CN’641 teaches a hemostatic device (paragraph [0003]) comprising:
a pressing member (3) configured to compress a patient's puncture site (paragraph [0025]);
a first band body (1) configured to be connectable to the pressing member (3) and configured to be rotatable about a first rotation axis (paragraph [0022] and Figure 3 shows the first band body 1 is placed over and rotatably disposed about the pressing member 3), the first band body (1) including
a second band body (2) configured to be connectable to the pressing member and configured to be rotatable about a second rotation axis (paragraph [0022] and Figure 3 shows the second band body 2 is placed over and rotatably disposed about the pressing member 3), the second band body (2) including
the pressing member (3) has a support member (31) and a protruding portion (33) provided on one surface of the support member and protruding in a direction away from the support member (Figure 3);
CN’641 teaches the first and second bands each have two free ends on opposite sides of the pressing member. Therefore, CN’641 does not teach a third band.
Like CN’641, Kiemeneij’602 teaches a hemostatic device for use on a vascular puncture (paragraph [0002]).
Kiemeneij’602 teaches a pressing member (140), a first band body (110), a second band body (120) and a third band body (130).
The first band body (110) has a first one end portion (111) connected to the pressing member and a free first end portion (112). The second band body (120) has a second one end portion (121) connected to the pressing member and a free second other end portion (122). The third band body (130) has a third one end portion (131) connected to the pressing member and a free third other end portion (132).
Kiemeneij’602 further teaches the first, second and third band bodies (110, 120, 130) are rotatable about a rotation axis (central axis going into the page in Figure 1) in order to adjust the angles (α, β, χ) in order to match or conform to the anatomy characteristics of a particular patient (paragraphs [0025], [0028], [0031]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 such that there are three bands each having one end connected to the pressing member and an opposite free end, such that the three bands are each rotatable about a rotation axis, as taught by Kiemeneij’602, in order to conform and match the anatomy characteristics in a patient and to provide hemostasis in the wrist and foot (paragraph [0002]).
CN’641 teaches the support member (31) includes a mechanical pressing element (30) and therefore does not teach the support member has an inflatable member. CN’641 does not teach the pressing element is fixed to the support member.
Kiemeneij’602 teaches a pressing member (140) can be in the form of a mechanical compression device (paragraph [0034]), as in CN’641, it can be an inflatable member (145) positioned on a support member 144. The inflatable member (145) is fixed to the support member (144) (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 by substituting a mechanical pressing element (30) with an inflatable member, as taught by Kiemeneij’602, because the substitution of one known element (i.e. a mechanical pressing element) for another (i.e. an inflatable member) would create predictable results. Specifically, Kiemeneij’602 teaches that both mechanical pressing elements and inflatable elements both achieve the same effect of applying pressure to a puncture wound to stop bleeding. The inflatable pressing device has the ability to more gradually increase pressure (e.g. by slowly inflating the chamber) in order to be more comfortable to the patient and it would be obvious to modify CN’641’s mechanical pressing element with an inflatable chamber, as taught by Kiemeneij’602, in order to provide this advantage.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 in which the pressing element is rotatably connected to the support plate, to a configuration in which the pressing element is fixed to the support plate, as in Kiemeneij’602, because the substitution of one connection mechanism (rotatable connection) for another (fixed connection) would yield the predictable result of applying pressure to stop bleeding at a puncture site. One of ordinary skill in the art would expect a hemostatic device with a movable connection between the support plate and the pressing element or a fixed connection between the support plate and the pressing element to perform equally well at stopping blood flow regardless of the connection because after the hemostatic device is applied to the patient, the pressing member does not move. A non-rotatable pressing element would be advantageous because it would allow the surgeon to have more control over the hemostatic device when attaching it to the body.
Claim 16: In CN’641, the protruding portion (33) is disposed at a position overlapping with the mechanical pressing element (30) in a plane direction of the support member (Figure 3).
In the resulting device of CN’641 in view of Kiemeneij’602, CN’641’s mechanical pressing element (30) is replaced with an inflatable bladder. Since the mechanical pressing element is disposed at a position overlapping with the protruding portion (33), it would be obvious that the substituted inflatable member would be in the same position and therefore also disposed at a position overlapping with the protruding portion (33).
Claim 18: Kiemeneij’602’s inflatable member (145) is considered to be connectable and separable from the support member 144 since it is connected during manufacture and it can be separated from the support member at least by cutting it off.
Claim 21: CN’641’s protruding portion has a cylindrical shape (Figures 1, 2).
Claims 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over CN’641 in view of Kiemeneij’602, as applied to claim 1 and 15, respectively further in view of Wood et al. (US Patent Publication 2008/0046010).
Claims 5, 19: CN’641 teaches the first and second band bodies include a main body portion (part of strap extending from the pressing member to the free end) and a hole portion (through which the protruding portion 33 extends, as shown in Figures 1 and 3).
CN’641 does not teach a hard portion surrounding the hole.
The use of reinforcements for holes in fabric is old and well known. For example, grommets are hard elements placed in a hole in fabric to reinforce the fabric around the hole. In particular, Wood’010 teaches a strap (14) with a hole portion (24) for receiving an element (pacifier 12). Wood’010 teaches providing the hole with a plastic washer or grommet on both sides of the strap in order to reinforce the hole portion to reinforce connection with the element (12) and to prevent tearing of the strap around the hole (paragraphs [0016], [0017]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641 by providing the hole portion with a hard portion around the hole (i.e. a plastic washer or grommet), as taught by Wood’010, in order to provide the stated advantage.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over CN’641 in view of Kiemeneij’602, as applied to claim 1, further in view of Hopkinson et al. (US Patent 2019/0314035)
Claim 8: CN’641, as modified, does not teach the support member has a curved region.
Like CN’641, Hopkinson’035 teaches a hemostasis device including a pressing member (110) and a first, second and third straps (120, 120, 120). The pressing member (110) includes a support member (130) for supporting an inflatable member (140). Hopkinson’035 teaches the support member can be flat, as in CN’641, or curved to conform to the anatomy of the patient upon securement (paragraph [0031]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’641, with a curved support member, as taught by Hopkinson’035, in order to conform to the anatomy of the patient upon securement.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over CN’641 in view of Kiemeneij’602, as applied to claim 1, further in view of Belanger et al. (WO 2015/008240).
Claims 10, 11: Kiemeneij’602 teaches the rotation of the three bands can be limited to less than 360 degrees (paragraphs [0025], [0028], [0031]), but does not specifically teach how this limiting is achieved and therefore does not teach a limiting portion.
Like CN’641 and Kiemeneij’602, Belanger’240 teaches a hemostasis device having a pressing member (16) and a pair of straps (14, 14). The straps (14, 14) can rotate about the pressing member (16) to adjust the position of the straps allow for proper attachment of the device to patient’s having different morphologies (paragraph [0010]).
Belanger’240 teaches limiting the rotation of each straps to less than 360 degrees (paragraph [0060]-[0062]) via a limiting portion including a protrusion portion (82) in strap attachment element (46) and a groove (64) formed in strap attachment element (44) (paragraphs [0077]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to apply the known technique of the motion limiting structure taught by Belanger’240 to the device of CN’641 and Kiemeneij’602, to limit rotation of the straps relative to the pressing element and make it easier to place the hemostasis device on a patient.
In the resulting device of CN’641 in view of Hopkinson’035, the support member (31) will be curved to conform to the patient’s anatomy and therefore will be convexly curved towards a direction in which the protruding portion (130) protrudes.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 15 December 2025
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771