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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10 in the reply filed on 07/22/2026 is acknowledged. The traversal is on the ground(s) that if the examiner finds the device of Group I in the art, there is more than likely a disclosure of a method of using it as described in Group II. This is not found persuasive because Groups I and II are distinct because the product as claimed can be used in a materially different process of using that product and applicant’s arguments do not address how the product as claimed cannot be used in a materially different process of using that product.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/22/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a stabilizing structural member” in claim 1;
“an actuating member” in claim 2
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-4 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hakky et al. (Pub. No.: US 2010/0331825 A1).
Regarding claim 1, Hakky discloses (fig. 2A-2B) an aspiration catheter (30, ¶ 0001) comprising:
A body (tubular member 32) having a proximal end (40) and an opposite distal tip (tip 54) with a lumen (channel 42) extending in a longitudinal direction therethrough from the proximal end to the distal tip (fig. 2A-2B, ¶ 0056); and
A stabilizing structural member (retaining mechanism 34) stabilizing the body to minimize movement and/or radial expansion of the distal tip of the body while subject to aspiration (¶ 0022).
Regarding claim 2, Hakky discloses an actuating member (actuation linkage 46) altering a parameter associated with the body when transitioning from a non-actuated state (fig. 2A) to an actuated state (fig. 2B) (¶ 0063);
Wherein, when the actuating member transitions from the non-actuated state to the actuated state, the stabilizing structural member transitions from a non-stabilizing state (fig. 2A) to a stabilizing state (fig. 2B) stabilizing the body to minimize movement of the distal tip of the body when subject to aspiration (¶ 0063).
Regarding claim 3, Hakky discloses wherein the actuating member is a pulling member extending longitudinally in the lumen fixedly secured to a distal section proximally of the distal tip (¶ 0057); and the pulling member is pullable in a proximal direction altering the parameter of longitudinal length of the body transitionable from a longitudinally elongated state when the pulling member is in the non-actuated state (fig. 2B) and longitudinally contracted state when the pulling member is in the actuated state (¶ 0058); and the stabilizing structural member expanding radially when the pulling member is in the actuated state with the body in the longitudinally contracted state stabilizing the body minimizing movement of the distal tip when subject to aspiration (fig. 2B, ¶ 0063).
Regarding claim 4, Hakky discloses wherein the stabilizing structural member is: (i) buckling of the body on alternating sides of a longitudinal centerline when the pulling member is in the actuated state with the body in the longitudinally contracted state (fig. 2B, ¶ 0061); (ii) a longitudinally compressible bellows section of the body with a plurality of discrete portions therein expandable radially when the pulling member is in the actuated state with the body in the longitudinally contracted state; or (iii) a sleeve, inflatable or prefilled with deformable matter, disposed externally about the body proximally of the distal tip.
Regarding claim 8, Hakky discloses wherein the stabilizing structural member is a knurled outer surface of a portion of the body itself (fig. 2B, ¶ 0061) or an inflatable balloon disposed thereabout.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakky, as applied to claim 2 above, and further in view of Lenker et al. (Pub. No.: US 2011/0112567 A1).
Regarding claim 5, Hakky fails to disclose wherein the stabilizing structural member is a nitinol wire associated with the body and the actuating member is an electrical circuit altering the parameter of temperature transitionable from a non-actuated state at a temperature below an Austenite transformation finish temperature to an actuated state at a temperature above the Austenite transformation finish temperature; wherein when the electrical circuit is in the non-actuated state at the temperature below the Austenite transformation finish temperature the nitinol wire is in a Martensite phase having a lower stiffness state, whereas when the electrical circuit is in the actuated state at the temperature above the Austenite transformation finish temperature the nitinol wire is in a Austenite phase having a higher stiffness stabilizing the body minimizing movement of the distal tip of the body when subject to the aspiration.
Lenker teaches (fig. 4B) a catheter (sheath 302) and thus in the same field of endeavor, comprising: a stabilizing structural member (expandable region 340), wherein the stabilizing structural member is a nitinol wire associated with a body (¶ 0081) and an actuating member that is an electrical circuit altering the parameter of temperature transitionable from a non-actuated state at a temperature below an Austenite transformation finish temperature to an actuated state at a temperature above the Austenite transformation finish temperature (¶ 0081); wherein when the electrical circuit is in the non-actuated state at the temperature below the Austenite transformation finish temperature the nitinol wire is in a Martensite phase having a lower stiffness state (¶ 0024), whereas when the electrical circuit is in the actuated state at the temperature above the Austenite transformation finish temperature the nitinol wire is in a Austenite phase having a higher stiffness (¶ 0024), in order to allow for the stabilizing structural member to transition between and expanded and collapsed configuration (¶ 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stabilizing structural member and the actuating member of Hakky such that the stabilizing structural member is a nitinol wire associated with the body and the actuating member is an electrical circuit altering the parameter of temperature transitionable from a non-actuated state at a temperature below an Austenite transformation finish temperature to an actuated state at a temperature above the Austenite transformation finish temperature; wherein when the electrical circuit is in the non-actuated state at the temperature below the Austenite transformation finish temperature the nitinol wire is in a Martensite phase having a lower stiffness state, whereas when the electrical circuit is in the actuated state at the temperature above the Austenite transformation finish temperature the nitinol wire is in a Austenite phase having a higher stiffness, as taught by Lenker, thus configuring the actuated state to stabilize the body minimizing movement of the distal tip of the body when subject to the aspiration, in order to allow for the stabilizing structural member to transition between and expanded and collapsed configuration (Lenker ¶ 0081).
Regarding claim 6, as discussed in claim 5 above, Hakky in view of Lenker disclose the austenite phase and the nitinol wire. Hakky in view of Lenker further disclose wherein while in the Austenite phase, the nitinol wire is shape set to a curved, undulating, or spiral shape (Lenker, ¶ 0024).
Claim(s) 7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakky, as applied to claim 1 above, and further in view of Casey et al. (Pub. No.: US 2021/0154433 A1).
Regarding claim 7, Hakky fails to disclose wherein the body is disposed within an outer sheath connected thereto via a living hinge acting as the stabilizing structural member isolating the distal tip of the body from the outer sheath so that the axial movement of the body while subject to the aspiration is not transmittable to the outer sheath.
Casey teaches (fig. 1, 10A-10B) an aspiration catheter (device 100, ¶ 0050) and thus in the same field of endeavor, comprising: a body (inner funnel catheter 104) disposed within an outer sheath (102) connected thereto via a living hinge (see membrane 110) acting as the stabilizing member isolating a distal tip (112) of the body from the outer sheath (fig. 10a-10b, ¶ 0058) so that the axial movement of the body while subject to the aspiration is not transmittible to the outer sheath (¶ 0080), wherein such configuration is configured to reduce friction upon delivery and expansion of the stabilizing structural member (¶ 0085).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hakky such that the body is disposed within an outer sheath connected thereto via a living hinge acting as the stabilizing structural member isolating the distal tip of the body from the outer sheath so that the axial movement of the body while subject to the aspiration is not transmittable to the outer sheath, as taught by Casey, in order to reduce friction upon delivery and expansion of the stabilizing structural member (Casey ¶ 0085).
Regarding claim 9, Hakky fails to disclose an outer sleeve disposed about the body and secured thereto via an elastomeric polymer defining an air gap therebetween acting as the stabilizing structural member stabilizing the body minimizing movement of the distal tip of the body when subject to aspiration; wherein the elastomeric polymer restores the body to a position substantially centered within the outer sleeve.
Casey teaches (fig. 1, 10A-10B) an aspiration catheter (device 100, ¶ 0050) and thus in the same field of endeavor, comprising: an outer sleeve (outer sheath 102) disposed about a body (inner funnel catheter 104) and secured thereto via an elastomeric polymer (membrane 110) defining an airgap therebetween (¶ 0080, ¶ 0085, fig. 10a-10b) acting as a stabilizing member stabilizing the body minimizing movement of the distal tip of the body when subject to aspiration (¶ 0080); wherein the elastomeric polymer restores the body to a position substantially centered within the outer sleeve (¶ 0085, fig. 10a-10b), wherein such configuration is configured to reduce friction upon delivery and expansion of the stabilizing structural member (¶ 0085).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Hakky such that it comprises an outer sleeve disposed about the body and secured thereto via an elastomeric polymer defining an air gap therebetween acting as the stabilizing structural member stabilizing the body minimizing movement of the distal tip of the body when subject to aspiration; wherein the elastomeric polymer restores the body to a position substantially centered within the outer sleeve, as taught by Casey, in order to reduce friction upon delivery and expansion of the stabilizing structural member (Casey ¶ 0085).
Regarding claim 10, Hakky fails to disclose wherein the body of the aspiration catheter has a radially self-expandable distal section including the distal tip; and wherein the stabilizing structural member is a tether associated with the radially self-expandable distal section restricting the radial expansion thereof while subject to the aspiration to prevent overexpansion.
Casey teaches (fig. 1, 8a-8c) an aspiration catheter (device 100, ¶ 0050) and thus in the same field of endeavor, wherein a body (inner funnel catheter 104) of the aspiration catheter has a radially self-expandable distal section including a distal tip (expanding distal tip 112) (¶ 0012, fig. 1); and wherein a stabilizing structural member is a tether (membrane 110) associated with the radially self-expandable distal section restricting the radial expansion thereof while subject to the aspiration to prevent over expansion (¶ 0080, ¶ 0082-¶ 0083), wherein such configuration reduces the radial force required by the distal tip to expand (¶ 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration catheter of Hakky such that the body of the aspiration catheter has a radially self-expandable distal section including the distal tip; and wherein the stabilizing structural member is a tether associated with the radially self-expandable distal section restricting the radial expansion thereof while subject to the aspiration to prevent overexpansion, as taught by Casey, in order to reduce the radial force required by the distal tip to expand (Casey ¶ 0083).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kallmes et al. (Pub. No.: US 2021/0346039 A1) discloses an aspiration catheter having a stabilizing structural member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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