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 responsive to the amendment filed on 03/06/2026. As directed by the amendment: claims 1, 4, 10, 11, and 13 have been amended and claims 2 and 14-20 have been cancelled. Thus, claims 1 and 3-13 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pg. 4, filed 03/06/2026, with respect to the objection of claims 1, 4, 8, 13, 15, and 18 have been fully considered and are persuasive. The objection of claims 1, 4, 8, 13, 15, and 18 has been withdrawn.
Applicant’s arguments, see pg. 4-5, filed 03/06/2026, with respect to the rejection of claims 8-11 and 18-20 under 35 U.S.C. 101 have been fully considered and are persuasive. The rejection of claims 8-11 and 18-20 under 35 U.S.C. 101 has been withdrawn.
Applicant’s arguments, see pg. 5, filed 03/06/2026, with respect to the rejection of claims 11 and 20 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 11 and 20 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 03/06/2026 have been fully considered but they are not persuasive. Applicant argues that Ginn cannot teach or suggest a sheath member that is greater in size than the vascular access point such that the sheath member is sized to impede entry into the vessel lumen because Ginn teaches advancing its device through the vascular access point and into the vessel lumen. The Office respectfully disagrees. The claim is a device claim to be limited by structural limitations. The structural limitations of the argued limitation are a sheath member. The size of the sheath member compared to a vascular access point is an intended used of the device as human organisms cannot be claimed. Ginn discloses the structure claimed (a sheath) and although the device of Ginn is shown as slightly smaller in fig. 4A-4D than the access point, access point openings come in a variety of sizes and Ginn could be used in one that is significantly smaller than shown and therefore significantly smaller than the outer diameter of the sheath. Therefore, The Office maintains that Ginn discloses the invention of claim 1.
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.
Claims 1 and 3-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ginn (US 20020077658 A1).
Regarding claim 1 Ginn discloses (fig. 4B-5B) a tamponade device, comprising:
a sheath member 112 comprising a hollow cavity defined along a length of the sheath member (see fig. 5A), the hollow cavity configured to allow insertion of a guidewire therein (see fig. 5A and [0065]),
wherein the sheath member 112 is configured to be positioned at a vascular access point of a subject over the guidewire deployed in a lumen of a blood vessel (see [0066]), and
wherein the sheath member 112 is configured with a predefined diametrical size (outer diameter) that impedes the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point of the subject (see fig. 4B-4D), thereby positioning the sheath member at the vascular access point to occlude the vascular access point of the blood vessel (see fig. 4B-4D and [0066]);
wherein the predefined diametrical size corresponds to an outer diameter of the sheath member 112 (see fig. 4B-4D), and wherein the outer diameter of the sheath member is greater than a size of the vascular access point (see fig. 4B-4D), thereby impeding the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point (see fig. 4B-4D and [0066]).
The language “thereby impeding the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Ginn meets the structural limitations of the claim, and the outer diameter of the sheath is capable of impeding the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point. The outer diameter of the sheath can be seen to be larger than the access point and thus is capable of impeding it from entering the blood vessel as additional force exerted by the user would be necessary to force it into the blood vessel. Although shown as slightly smaller in fig. 4A-4D, access point openings come in a variety of sizes and could include one significantly smaller than shown and therefore significantly smaller than the outer diameter of the sheath.
The Office notes that the delivery of element 112 is as shown in fig. 4B-4D with the only difference being the closing of the lumen (see [0065]).
Regarding claim 3 Ginn further discloses (fig. 4B-5B) the hollow cavity is configured with a first dimension (inner diameter of 112, see fig. 5A), the first dimension of the hollow cavity corresponding to an inner diameter of the sheath member (see fig. 5A), and wherein the hollow cavity of the first dimension allows insertion of the guidewire therein (see fig. 5A and [0065]).
Regarding claims 4 Ginn further discloses (fig. 4B-5B) the sheath member 112 when positioned at the vascular access point is configured to apply focal pressure at the vascular access point of the subject, thus resulting in hemostasis at the vascular access point (see fig. 4D and [0068]).
Regarding claims 5 and 6 Ginn further discloses (fig. 4B-5B) a plunger 136 comprising a passageway 144 for allowing the guidewire to be inserted therein (see fig. 5A, [0063] and [0065]); an outer circumferential surface of the plunger 136 is configured in conformity with a second dimension (inner diameter of 112) of a hollow cavity of a sheath member (see fig. 5A), thereby allowing the plunger to be accommodated in the hollow cavity of the sheath member (see fig. 5A and [0063]).
Regarding claims 7 and 8 Ginn further discloses (fig. 4B-5B) the second dimension (inner diameter of 112) of the hollow cavity corresponds to an inner diameter of the sheath member (see fig. 5A and [0063]); the sheath member 112 and the plunger 136 accommodated therein are configured to be positioned at a vascular access point of a subject over a guidewire deployed in a lumen of a blood vessel (see [0066]).
Regarding claims 9 and 10, Ginn further discloses (fig. 4B-5B) the sheath member 112 of a predefined diametrical size and the plunger 136 of an outer circumference (see fig. 5A) impedes the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point of the subject (see note below), thereby positioning the sheath member and the plunger at the vascular access point to occlude the vascular access point of the blood vessel (see fig. 4D and [0068]); the sheath member 112 and the plunger 136 when positioned at the vascular access point (the lounger is positioned at the vascular access point prior to removal; see [0067]) are configured to apply focal pressure the vascular access point of the subject, thus resulting in hemostasis at the vascular access point (see fig. 4B-4D and [0068]).
Note: The language “the sheath member of a predefined diametrical size and the plunger of an outer circumference impedes the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point of the subject” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Ginn meets the structural limitations of the claim, and the outer diameter of the sheath is capable of preventing the tamponade device from being deployed into the lumen of the blood vessel through the vascular access point. The outer diameter of the sheath can be seen to be larger than the access point and thus is capable of preventing it from entering the blood vessel as additional force exerted by the user would be necessary to force it into the blood vessel. Although shown as slightly smaller in fig. 4A-4D, access point openings come in a variety of sizes and could include one significantly smaller than shown and therefore significantly smaller than the outer diameter of the sheath.
Regarding claim 11 Ginn further discloses (fig. 4B-5B) the sheath member 112 is adapted to guide the plunger 136 to be positioned at the vascular access point (see fig. 4B-4D and 5A).
Regarding claim 12 Ginn further discloses (fig. 4B-5B) the sheath member 112 is made of biocompatible plastic materials (see [0034]).
Regarding claim 13 Ginn further discloses (fig. 4B-5B) the sheath member 112 is configured to be positioned at the vascular access point to occlude the lumen of the blood vessel (see fig. 4D and [0068]) based on a serial dilation induced by a dilator device at the vascular access point. The language “sheath member is configured to be positioned at the vascular access point to occlude the lumen of the blood vessel based on a serial dilation induced by a dilator device at the vascular access point” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Ginn meets the structural limitations of the claim, and the sheath member is capable of being positioned at the vascular access point is capable of occlude the lumen of the blood vessel based on a serial dilation induced by a dilator device at the vascular access point. The sheath member positioned at the vascular access point occludes the lumen and would be capable of occluding the lumen if it was formed from a serial dilation induced by a dilator.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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