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 § 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 12 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 12 recites: “wherein the plurality of scalloped members each comprise a similar shape.” The term “similar” is a relative term of degree. The claim does not identify the reference object against which similarity is assessed, define the required degree of similarity, or state an objective criterion by which a skilled artisan can distinguish a “similar” shape from a non-similar shape.
The specification describes curved scalloped members, triangular or elliptical alternatives, and differently shaped members on a single tip structure. It also describes variations in size, depth, and width. It does not, however, set a standard that determines when different geometric members are still “similar” for purposes of this limitation. Accordingly, the claim does not provide a reasonably ascertainable boundary for the term “similar.” A person of ordinary skill cannot determine the metes and bounds of this limitation with reasonable certainty.
Examiner’s Comment
PCT/US2024/031860 includes a rejection of claims 1-20 of this application made by the U.S. Patent and Trademark Office as the international searching authority (ISA). The pending rejection of claims 1-20 complies with all the requirements of section 102. According to the record, it appears that there is no response to this international office action. Therefore, the rejection has been included in the following section of this office action to provide Applicant the opportunity to formally respond to the rejection and clarify the record.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vale et al. (US 2021/0393277A1; hereinafter “Vale”).
In relation to claim 1, Vale discloses a catheter construction for use in a vessel (an expandable mouth for a catheter for retrieving an occlusive clot; abstract), the catheter construction comprising: a catheter body (outer catheter 30; paragraph [0064]) having a catheter lumen (catheter lumen 44; paragraph [0086]) extending therethrough (FIGs. 1 and 2 illustrates the catheter lumen 44 extending therethrough the outer catheter 30); and a tip structure (expandable tip 100; paragraph [0036]) located at a distal end of the catheter body (the tip section 24 is at a distal end of the catheter body; paragraph [0064]), where an end of the tip structure located opposite to the catheter body comprises an undulating shape (the expandable tip 100 may have sinusoidal wave patterns that can, via their peaks and amplitudes, constitute an undulating shape; paragraph [0085]) forming a plurality of scalloped members (petals 215; paragraph [0107]), where each scalloped member of the plurality of scalloped members is configured to flex individually from an adjacent scalloped member (the petals 215 can be configured to lengthen and shorten independently; paragraph [0108]), such that when advanced against a vessel wall, the plurality of scalloped members are configured to flex and bend independently to assist in articulation of the tip structure (the petals 215 can be configured to lengthen and shorten independently in response to the forces experienced during navigation through an outer catheter or during a thrombectomy procedure when the tip 200 is deployed and expanded at a target site; paragraph [0108]; such configuration allows for the tip to contact vessel walls while avoiding vessel trauma and reducing friction; paragraph [0011]).
In relation to claim 2, Vale discloses the catheter construction of claim 1 and further discloses at least one material strip (membrane or cover or membrane cover 50 and also referred to as jacket(s); paragraphs [0100]-[0103]) extending in the tip structure (the cover 50 extends in the tip structure; FIGs. 21A-21C), where the at least one material strip comprises a first durometer (the jackets may be disposed in an axial series to transition the overall stiffness, i.e., a first durometer; paragraph [0070]), where the first durometer is different than a second durometer of a remainder of the tip structure (areas not covered with jacket(s) have a different stiffness, i.e., a second durometer; paragraph [0070]).
In relation to claim 3, Vale discloses the catheter construction of claim 2 and further discloses wherein the first durometer is higher than the second durometer (the jackets may be constructed from stiffer materials with reduced elastic strain capacity and elongation at break; paragraph [0086]).
In relation to claim 4, Vale discloses the catheter construction of claim 2 and further discloses wherein the at least one material strip extends in alignment with an axis of the tip structure (the jackets may be configured in axial series or radial series disposed about the support tube, which is located within the outer catheter 30; paragraph [0070]).
In relation to claim 5, Vale discloses the catheter construction of claim 2 and further discloses wherein the at least one material strip extends spirally about the tip structure (the jackets may be configured in axial series or radial series disposed about the support tube, which is located within the outer catheter 30. The support frame 210 has a plurality of undulations 130 that form petals and may have a helical
twist, equating to extending spirally; paragraph [0118]).
In relation to claim 6, Vale discloses the catheter construction of claim 1 and further discloses wherein the plurality of scalloped members extend parallel to an axis of the tip structure (the petals 215 may extend parallel to an axis 111 of the expandable tip 100; FlGs. 14B-14C; paragraph [00701).
In relation to claim 7, Vale discloses the catheter construction of claim 1 and further discloses wherein the plurality of scalloped members extend at an angle to an axis of the tip structure (the petals 215 may extend at an angle a to an axis 111 of the expandable tip 100; FIG. 17C; paragraph [0094]).
In relation to claim 8, Vale discloses the catheter construction of claim 1 and further discloses wherein at least one of the plurality of scalloped members is configured to deflect towards an axis of the tip structure (the petals 215 may deflect towards an axis 111 of the expandable tip 100; FIGs. 27A-27D; paragraph [0114] explaining the petals can curve radially inward).
In relation to claim 9, Vale discloses the catheter construction of claim 1 and further discloses wherein at least one of the plurality of scalloped members is configured to deflect outward away from an axis of the tip structure (the petals 215 may deflect outward away from an axis 111 of the expandable tip 100; FlGs. 25A-25D).
In relation to claim 10, Vale discloses the catheter construction of claim 1 and further discloses wherein at least one scalloped member of the plurality of scalloped members comprises a neck area comprising a reduced surface area relative to a remainder of the at least one scalloped member (the petals 215 may include a neck in the form of arms 112 that have a reduced surface area relative to a remainder of the at least one scalloped member; FIG. 278).
In relation to claim 11, Vale discloses the catheter construction of claim 1 and further discloses wherein at least two of the plurality of scalloped members each comprise a different shape (the petals 215 may comprise different shapes; paragraph [0107]; compare in FIG. 27C the size of the petal 215 disposed along axis 111 with the remaining petals 215).
In relation to claim 12, Vale discloses the catheter construction of claim 1 and further discloses wherein the plurality of scalloped members each comprise a similar shape (the petals 215 may comprise similar shapes; paragraph [0107]; compare in FIG. 27C the petals 215 not disposed on the axis 111).
In relation to claim 13, Vale discloses the catheter construction of claim 1 and further discloses wherein at least one of the plurality of scalloped members comprises a shape that narrows toward a distal tip (the petals 215 may comprise a shape that narrows toward a distal tip; FIG. 258 illustrates petals 215 tapering at a distal tip).
In relation to claim 14, Vale discloses the catheter construction of claim 1 and further discloses wherein at least one of the plurality of scalloped members comprises a shape that increases toward a distal tip (the petals 215 may comprise a shape that increases toward a distal tip; FIG. 27A illustrates a petal 215 increasing towards a distal tip).
In relation to claim 15, Vale discloses a catheter construction for use in a vessel (an expandable mouth for a catheter for retrieving an occlusive clot; abstract), the catheter construction comprising: a catheter body (outer catheter 30; paragraph [0064]) having a catheter lumen (catheter lumen 44; paragraph [0086]) extending therethrough (FIGs. 1 and 2 illustrates the catheter lumen 44 extending therethrough the outer catheter 30); and a plurality of scalloped members (petals 215; paragraph [0107]) located at a distal end of the catheter body (the petals 215 are located at a distal end of the outer catheter 30; FIG. 1 paragraph [0107]) and formed from an undulating shape pattern (the expandable tip 100 may have sinusoidal wave patterns that can, via their peaks and amplitudes, constitute an undulating shape; paragraph [0085]) such that each scalloped member of the plurality of scalloped members is configured to flex individually from an adjacent scalloped member, such that when advanced against a vessel wall, flexing of one or more of the plurality of scalloped members causes asymmetric bending of a tip of the catheter body (the petals 215 can be configured to lengthen and shorten independently in response to the forces experienced during navigation through an outer catheter or during a thrombectomy procedure when the tip 200 is deployed and expanded at a target site; paragraph [0108]; such configuration allows for the tip to contact vessel walls while avoiding vessel trauma and reducing friction; paragraph [0011]; the undulations in the pattern, as well as the petals being unconnected with one another, allows the individual petals to flex and bend more freely, such that asymmetric bending of the tip occurs; paragraph [0112]).
In relation to claim 16, Vale discloses the catheter construction of claim 15 and further discloses at least one material strip (membrane or cover or membrane cover 50 and also referred to as jacket(s); paragraphs [0100]-[0103]) extending in the tip structure (the cover 50 extends in the tip structure; Fl Gs. 21A-21C), where the at least one material strip comprises a first durometer (the jackets may be disposed in an axial series to transition the overall stiffness, i.e., a first durometer; paragraph [0070]), where the first durometer is different than a second durometer of a remainder of the tip of the catheter body (areas not covered with jacket(s) have a different stiffness, i.e., a second durometer; paragraph [0070]).
In relation to claim 17, Vale discloses the catheter construction of claim 16 and further discloses wherein the at least one material strip extends in alignment with an axis of the tip (the jackets may be configured in axial series or radial series disposed about the support tube, which is located within the outer catheter 30; paragraph [0070]).
In relation to claim 18, Vale discloses the catheter construction of claim 16 and further discloses wherein the at least one material strip extends spirally about the tip (the jackets may be configured in axial series or radial series disposed about the support tube, which is located within the outer catheter 30; paragraph [0070]).
In relation to claim 19, Vale discloses the catheter construction of claim 15 and further discloses wherein the plurality of scalloped members extend parallel to an axis of the tip (the petals 215 may extend parallel to an axis 111 of the expandable tip 100; FlGs. 148-14C; paragraph [0070]).
In relation to claim 20, Vale discloses a catheter construction for use in a vessel (an expandable mouth for a catheter for retrieving an occlusive clot; abstract), the catheter construction comprising: a catheter body (outer catheter 30; paragraph [0064]) having a catheter lumen (catheter lumen 44; paragraph [0086]) extending therethrough (FIGs. 1 and 2 illustrates the catheter lumen 44 extending therethrough the outer catheter 30); and a tip structure (expandable tip 100; paragraph [0036]) located at a distal end of the catheter body (the tip section 24 is at a distal end .of the catheter body; paragraph [0064]), where an end of the tip structure located opposite to the catheter body comprises an undulating shape (the expandable tip 100 may have sinusoidal wave patterns that can, via their peaks and amplitudes, constitute an undulating shape; paragraph [0085]) forming at least one scalloped member (petal 215; paragraph [0107]) configured to flex individually from a portion of the tip structure (the petals 215 have arms 216 that may bend and flex independently about their own axes, i.e., individually from a portion of the tip structure; paragraph [0116]), such that when advanced against a vessel wall, the at least one scalloped members is configured to flex and bend independently to assist in articulation of the tip structure (the petals 215 can be configured to lengthen and shorten independently in response to the forces experienced during navigation through an outer catheter or during a thrombectomy procedure when the tip 200 is deployed and expanded at a target site; paragraph [0108]; such configuration allows
for the tip to contact vessel walls while avoiding vessel trauma and reducing friction; paragraph [0011]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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