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 § 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.
Claim 25 is 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.
Claim 25 recites “the…second haemostatic valve.” There is insufficient antecedent basis for this limitation in the claim.
Claim 25 refers to the intended use or result of the product. It is unclear what structural features are required by this limitation. Further clarification is required.
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, 8, 16, 19, 22 is/are rejected under 35 U.S.C. 10 as being anticipated by Tal et al. [US 2018/0014829 A1, hereinafter “Tal”]
Re. claim 1, Tal discloses:
An endovascular occlusion [Par. 0013] device [Fig. 1-2] comprising a deformable sleeve [14] displaceable between a collapsed state [Fig. 2B] and an expanded state [Fig. 2A]; and
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a conical [Fig. 2A] array of cantilevered arms [20, which are cantilevered because they are supported only at one end (by hinge 22); note that element 26 is not a support but a manipulation member which causes the arms to fold or unfold, Par. 0039] extending from a distal end of the sleeve [Annotated Fig. 1] and converging towards distal tips [Annotated Fig. 1] such as to define a first haemostatic valve about the distal end of the sleeve [Due to the presence of covering 24 which is impervious to blood flow and the closable protrusions, a hemostatic valve is defined: “movement of the foldable protrusions 20 closer to one another creates or increases occlusion of the flow in the body lumen,” Par. 0038].
Re. claim 8, Tal discloses: one or more of the distal tips is longitudinally offset to one or more of the other distal tips [see Fig. 1. The distal tips are arranged in a circle so that their tips are longitudinally offset from one another].
Re. claim 16, Tal discloses: An endovascular occlusion device in which the sleeve comprises a plurality of interconnected annular sinusoidal ribs defining a reticulated cylindrical sidewall [Fig. 1, ribs 16.
Re. claim 19, Tal discloses: a membrane [24] enclosing the cantilevered arms and at least a portion of the distal end of the sleeve [Fig. 1]
Re. claim 22, Tal discloses: one or more elements [Annotated Fig. 1 below] provided at a proximal end of the sleeve and configured to facilitate recapture of the occlusion device [the narrow point, like that in the instant application, facilitates recapture].
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Claim(s) 1, 2, 16, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fox et al. [US 2019/0110880 A1, hereinafter “Fox”]
Re. claim 1, Fox discloses:
An endovascular occlusion [Par. 0005] device [Fig. 2] comprising a deformable sleeve [30] displaceable between a collapsed state [Fig. 1A] and an expanded state [Fig. 1B]; and
a conical [Fig. 2] array of cantilevered arms [430] extending from a distal end of the sleeve [Fig. 4, shown as the distal end in Figs 1B-C] and converging towards distal tips [Annotated Fig. 2]
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such as to define a first haemostatic valve about the distal end of the sleeve [the device serves to occlude blood flow, See Par. 0005-6, so the distal end may be considered to form a hemostatic valve].
Re. claim 2, Fox discloses: An endovascular occlusion device according to claim 1 in which the resilience of the array of cantilevered arms acts to bias the first haemostatic valve into a closed state [Par. 0112].
Re. claim 16, Fox discloses: An endovascular occlusion device in which the sleeve comprises a plurality of interconnected annular sinusoidal ribs defining a reticulated cylindrical sidewall [Fig. 9].
Re. claim 17, Fox discloses: An endovascular occlusion device according to claim 16 in which the cylindrical sidewall comprises a plurality of radially outwardly extending projections [206, Fig. 9].
Claim(s) 1, 2, 16, 18-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shohat et al. [US 20220061852 A1, hereinafter “Shohat”].
Re. claim 1, Shohat discloses:
An endovascular occlusion [Par. 0046-0047] device [Fig. 1-2] comprising a deformable sleeve [14] displaceable between a collapsed state [Fig. 8] and an expanded state [Figs. 11A-B]; and
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a conical [Figs. 11A-B] array of cantilevered arms [Annotated Fig. 2, which are cantilevered because they are supported only at one end (by hinge 22); note that element 18 is not a support but a manipulation member which causes the arms to fold or unfold, Par. 0051] extending from a distal end of the sleeve [Fig. 2]
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and converging towards distal tips [Annotated Fig. 2] such as to define a first haemostatic valve about the distal end of the sleeve [Pars. 0040, 0052].
Re. claim 16, Shohat discloses: An endovascular occlusion device according to any claim 1in which the array of cantilevered arms are sufficiently resiliently deformable to permit the tips to separate radially to facilitate the passage of a surgical implement [the arms may be closed or opened, see Figs. 11A-B, but facilitate passage of a surgical instrument 24].
Re. claim 16, Shohat discloses: An endovascular occlusion device in which the sleeve comprises a plurality of interconnected annular sinusoidal ribs defining a reticulated cylindrical sidewall [Figs 1-2].
Re. claim 18, Shohat discloses: a remotely operable actuator arranged to effect displacement of the sleeve between the expanded and collapsed states [30, Par. 0049].
Re. claim 19, Shohat discloses: a membrane [20, Par. 0047] enclosing the cantilevered arms and at least a portion of the distal end of the sleeve [Fig.2]
Re. claim 20, Shohat discloses: An endovascular occlusion device according to claim 19 in which the membrane surrounds the distal tip of at least one of the cantilevered arms [Fig. 2].
Re. 21 20, Shohat discloses: An endovascular occlusion device according to claim 19 in which the membrane is dimensioned to accommodate relative displacement between at least two adjacent cantilevered arms [Figs. 11A-B show the membrane and the displacement between at least two adjacent arms].
Re. claim 22, Shohat discloses: one or more elements [narrow waist connecting to 12] provided at a proximal end of the sleeve and configured to facilitate recapture of the occlusion device [the narrow point, like that in the instant application, facilitates recapture].
Claim Rejections - 35 USC § 103
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tal, or Shohat, in view of Hyde et al. [US 20140135816 A1, hereinafter “Hyde”].
Re. claim 6, the above references disclose one or more of the cantilevered arms comprises a hinge but fail to disclose a live hinge. However, Hyde teaches a live hinge [Par. 0166]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tal (or Shohat) by replacing the hinge with a live hinge as taught by Hyde because this amounts to a simple substitution of one type of hinge known as suitable in the art for another.
Claim(s) 26, 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shohat in view of Epstein et al. [US 20080039786 A1, hereinafter “Epstein”].
Re. claim 26, Shohat discloses
A method of delivering a therapeutic agent into a lumen of the endovascular system [Par. 0009] comprising:
locating into the lumen in a collapsed state an occlusion device [14] comprising a deformable sleeve [Annotated Fig. 11A] and a conical array of cantilevered arms extending from a distal end of the sleeve and converging towards distal tips [Fig. 11A; see claim 1 above];
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expanding the sleeve to anchor the occlusion device within the lumen such that the cantilevered arms define a first haemostatic valve [Figs. 11A-B, Par. 0040]; and
passing a surgical implement through the array of arms [Fig. 3] to deliver the therapeutic agent [Par. 0061]
Shohat fails to disclose the therapeutic agent being introduced distally of the occlusion device. However, Epstein teaches, in a method for occluding blood flow and delivering a therapeutic agent, passing a surgical implement [130] through an array of arms [Fig. 10B] to deliver the therapeutic agent distally [via 131, Par. 0038], of the occlusion device [710]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Shohat by configuring the system to pass a surgical instrument through the array of arms to deliver the therapeutic agent distally of the occlusion device, as taught by Epstein, because this “allows the therapeutic agent to be delivered to the intended treatment site without being diluted or removed by the flow of blood” [Epstein Par. 0028].
Re. claim 33, Shohat discloses manipulating the surgical implement in multiple non-axial directions distal to the occlusion device [Fig. 2] [“in order to achieve optimal therapeutic delivery of the therapeutic agent” relates to the intended result of this step, not given further patentable weight].
Allowable Subject Matter
Claims 4-5, 7, 9-15, 23-24, 27-32, 34 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tockman et al. [US 7935075 B2] discloses a vascular occlusion device comprising a deformable sleeve [30, Fig. 5A] displaceable between a collapsed state and an expanded state, and a
Leedle [US 2013/0289710 A1] discloses a vascular occlusion device comprising a deformable sleeve [Figs. 1-3] displaceable between a collapsed state and an expanded state, and a conical [Par. 0016] array of cantilevered arms [20] extending from a distal end of the sleeve and converging towards distal tips so as to define a first hemostatic valve
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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