DETAILED ACTION
Claims 1-20 are canceled. Claims 21-40 are newly added claims. A complete action on the merits of pending claims 21-40 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 11/18/2025 which are entered. Given that Applicant canceled claims 1-20 in the response filed on 11/18/2025, all claim objections, 35 USC 112(f) interpretations, 35 USC 112(b), 112(d), and 101 rejections documented in the Final Office Action sent on 04/05/2024 are withdrawn.
Claim Objections
Claims 32, 34, and 39 are objected to because of the following informalities:
Claims 32, 34, and 39 contain grammatical errors in the phrasing “intertwine the expanded netting” and “intertwine/intertwining the one or more loops.” The verb “intertwine” requires the preposition “with.” Further, in terms of claim 32, the phrase “the expanded netting” should be the “expanded netting shape” given that the limitation was introduced as such in claim 27 and is being referred to as such in the other claims that depend upon claim 27, which includes claim 32 (depends upon claim 31 which depends on claim 27).
Claim 39 also contains an incomplete and grammatically incorrect clause, “and intertwining the endovascular coil with the netting of the retaining device within the aneurysmal includes intertwining the one or more loops” should be “and intertwining the endovascular coil with the netting of the retaining device within the aneurysmal sac includes intertwining the one or more loops.”
Appropriate correction is required.
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.
Such claim limitation(s) is/are: “retaining means for fitting within and sliding along a lumen of a catheter in a compressed configuration, and for expanding outward into an aneurysmal sac in a relaxed configuration, thereby covering an inner mouth of the aneurysmal sac” in claim 40.
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.
The corresponding structure disclosed in the specification that performs the recited function is the retaining device (114) comprising:
A base (116) configured for removable attachment to a delivery wire via a severable joint (140);
An umbrella-shaped netting (124) formed by a plurality of ribs (134) supporting netting webs (136) with open spaces (135);
One or more fingers (126) extending from the base (optionally forming loops (132)); and
Construction from a shape-memory alloy (e.g. Nitinol) or biocompatible shape-memory polymer (e.g., polyurethane-based), with optional position markers (156).
See specification paragraphs [0046]-[0050], [0053]-[0054] and Figures 5-10 and 12-14.
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 § 112
Claim 39 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 39 recites the limitation "the expanded netting shape". There is insufficient antecedent basis for this limitation in the claim. The phrase “an expanded netting shape” first appears in claim 27 (which depends upon claim 21). Claim 39 depends upon claim 38, which depends upon claim 37, which depends upon claim 21; neither claim 21, 37, nor 38 incorporate the limitations of claim 27 or any other claim that recites the expanded netting shape. Therefore, no antecedent exists within the proper dependency chain. Will be interpreted in view of claim 37’s limitation “netting of the retaining device” as “the netting of the retaining device is in an expanded netting shape that”.
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) 21-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lorenzo (US PGPUB No. 20190008522 A1).
Regarding claim 21, Lorenzo discloses, an intrasaccular stent device for aneurysm treatment (Figures 1-6, delivery system (10); Paragraph [0041]), comprising: a retaining device (Figures 1-6, occlusion device (20); Paragraph [0041]) having a plurality of structural configurations (Figures 1-6), including:
a compressed configuration (Figures 1-2) in which the retaining device is configured to fit within and slide along a lumen (Figures 1-5, catheter lumen (11)) of a catheter (Figures 1-5, microcatheter (12)) (Paragraphs [0041]-[0042]), and
a relaxed configuration (Figures 3-6) in which the retaining device is configured to expand outward into an aneurysmal sac (Figures 1, 3-4, & 6, sac (S) of aneurysm (A)) (Paragraph [0043]).
Regarding claim 22, Lorenzo further discloses, wherein the retaining device (occlusion device (20)) includes a base (Figures 2-6, control ring (22); Paragraph [0042]) from which the retaining device is configured to expand outward in the relaxed configuration (Figures 3-6; Paragraphs [0042]-[0043]; Where clearly occlusion device (20) is expanding outward from control ring (22) in the expanded/relaxed configuration/state).
Regarding claim 23, Lorenzo further discloses, wherein the base (control ring (22)) is configured to be removably attached to an end of a delivery wire (Figures 1-5, delivery tube (14); Paragraphs [0041]-[0045]; Under the broadest reasonable interpretation (BRI) consistent with the specification, the term “delivery wire” is an elongate member that: 1) is inserted through the catheter lumen; 2) releasably attaches at its distal end to the base of the retaining device; 3) transmits axial push force to deploy/position the device; 4) supports detachment at the distal end; and 5) is withdrawn proximally after release. Lorenzo’s delivery tube (14) satisfies each limitation: it is advanced through the catheter lumen (“delivery tube (14) is advanced within lumen (11)” (Paragraph [0043]), its distal grabber (30) releasably grips the base/control ring (22) (Paragraph [0042]-[0043]), it pushes the device for deployment (Paragraph [0043]), detachment occurs at the distal interface when the grabber disengages (Paragraph [0045]), and the tube is withdrawn (Figure 6). The specification of the current invention does not exclude tubular structures from “delivery wire,” and thin-walled tubular pushers (e.g., nitinol tube (Paragraph [0047] of Lorenzo)) are commonly used as delivery wires in the art for the exact functions).
Regarding claim 24, Lorenzo further discloses, further comprising the delivery wire (delivery tube (14)), configured to be removably attached to the base (control ring (22)) (Paragraphs [0042]-[0043] & [0045]).
Regarding claim 25, Lorenzo further discloses, further comprising a severable joint (Figure 5, grabber (30)) removably attaching the delivery wire to the base (Paragraphs [0042]-[0043] and [0045]).
Regarding claim 26, Lorenzo further discloses, wherein the retaining device (occlusion device (20)) is configured to transition from the compressed configuration to the relaxed configuration when emerging from an open end of the catheter (Figures 2-3; Paragraph [0043], “…the delivery tube 14 is advanced within lumen 11 of catheter 12 to enable occlusion device 20 to expand into an approximately hemi-spherical shape within sac S as shown in FIG. 3.”).
Regarding claim 27, Lorenzo further discloses, wherein in the relaxed configuration, the retaining device (occlusion device (20)) takes on an expanded netting shape (Figure 5, structure (25); Paragraphs [0042] and [0048]) configured to cover an inner mouth (Figures 1, 4, & 6, neck (N) of aneurysm (A)) of the aneurysmal sac (sac (S) of aneurysm (A)) (Paragraphs [0043]-[0044], “…expand into an approximately hemi-spherical shape within sac (S)…” and “the shape of occlusion device (20) will conform to the shape of the sac (S)” “…while block[ing] neck (N)…”. Hemi-spherical mesh bridging the neck from inside).
Regarding claim 28, Lorenzo further discloses, wherein the expanded netting shape (structure (25) of occlusion device (20)) includes a plurality of fingers (Paragraphs [0042] and [0048] disclose structure (25) of occlusion device (20) as including mesh body (24) and as being a “braided mesh tube” with “metallic filaments”. The filaments and mesh elements as seen in the Figures extend into the sac from the proximal control ring region, constituting the “plurality of fingers” (braided filament extensions)).
Regarding claim 29, Lorenzo further discloses, wherein the expanded netting shape (structure (25) of occlusion device (20)) includes a plurality of ribs (Paragraph [0048] discloses structure (25) of occlusion device (20)/mesh is formed of “metallic filaments that establish an expandable braided mesh tube” with structural support element. The braided construction inherently includes rib-like or strut-like filament paths functioning as “plurality of ribs”).
Regarding claim 30, Lorenzo further discloses, wherein at least one rib of the plurality of ribs includes a position marker (Paragraph [0048] discloses with relevance to structure (25) of occlusion device (20) whose braided construction inherently includes rib-like or strut-like filament paths functioning as “plurality of ribs”, “Preferably, at least one platinum wire is included for radiopacity.”).
Regarding claim 31, Lorenzo further discloses, wherein the expanded netting shape (structure (25) of occlusion device (20)) includes an opening (Figures 2 and 5, inner passage (26); Paragraph [0042]) configured to receive an endovascular coil (Figures 4 and 6, embolic coil (40)) into the aneurysmal sac (sac (S) of aneurysm (A)) (Paragraphs [0044]-[0045]).
Regarding claim 32, Lorenzo further discloses, further comprising the endovascular coil (embolic coil (40)), wherein the endovascular coil is configured to intertwine with the expanded netting shape of the retaining device (structure (25) of occlusion device (20); Paragraph [0044], “…at least one embolic coil 40, FIG. 4, is advanced through lumen 15 of delivery tube 14 as indicated by arrow 42, through passage 26 of control ring 22 as indicated by arrow 44, and is advanced, arrow 46, within aneurysm A to substantially fill sac S and to anchor body 24 of occlusion device 20 against the interior wall of aneurysm A to block neck N as shown in FIG. 6.” The coil is delivered through the inner passage directly into the interior of the expanded hemi-spherical mesh netting where it fills the sac and would mechanically interweave/entangle with the braided filaments of the netting to anchor the device in place).
Regarding claim 33, Lorenzo further discloses, wherein the expanded netting shape includes a plurality of fingers (braided metallic filament extensions of main body (24)/structure (25) extending from the control ring in the sac, as mapped in claim 28 above), wherein at least some of the plurality of fingers form one or more loops (the expandable braided mesh tube construction inherently forms interwoven filament crossings and loop-like enclosures where the metallic filaments cross and encircle one another throughout the mesh body (see Figures 1-6); Paragraph [0048], “…the structure 25 of occlusion device 20 is formed of metallic filaments that establish an expandable braided mesh tube.”).
Regarding claim 34, Lorenzo further discloses, wherein the endovascular coil (embolic coil (40)) is configured to intertwine with the one or more loops (the embolic coil (40) is advanced into the sac interior and expands to fill the volume, thereby passing through and mechanically entangling with the loop-like filament crossings and enclosures of the braided netting; Paragraph [0044] (anchoring function) and Paragraph [0048] (braided mesh structure)).
Regarding claim 35, Lorenzo further discloses, wherein the intertwined endovascular coil forms a structure that is too large to pass through the opening (the deployed and coiled mass of embolic coil (40) intertwined/entangled within the structure (25)/main body (24) of the occlusion device (20) creates a cohesive, volume-filling structure inside the sac (S) (see Figure 6) that, together with the device anchored across the neck (N), cannon migrate back through inner passage (26) or the aneurysm neck; Paragraph [0044], “…to substantially fill sac S and to anchor body 24 of occlusion device 20 against the interior wall of aneurysm A to block neck N as shown in FIG. 6.”).
Regarding claim 36, Lorenzo further discloses, wherein the expanded netting shape (structure (25) of occlusion device (20)) prevents the endovascular coil (embolic coil (40)) from exiting the aneurysmal sac (sac (S) of aneurysm (A)) into a parent blood vessel (Figures 1, 3-4, & 6, blood vessel (BV);Paragraph [0041]) (the hemi-spherical mesh body (24) of structure (25) of occlusion device (20) is positioned across and confirms to the inner mouth/neck (N) from inside the sac (see Figure 6), thereby physically blocking any portion of the embolic coil (40) from migrating out of the sac (S) into the parent blood vessel (BV); Paragraphs [0044] and [0056], “… to block neck N …” and the device “… serves as a cover extending at least across neck N … to enhance occlusion …”).
Regarding claim 37, Lorenzo further discloses, a process of emplacing an intrasaccular stent device for aneurysm treatment (implantation of occlusion device (20) as shown in Figures 1-6; Paragraphs [0041]-[0045]), comprising:
positioning an open end of a stent catheter in an aneurysmal sac (microcatheter (12) distal open end positioned at the neck (N) such that the device deploys directly into sac (S); Figure 1 and Paragraph [0041]);
inserting the retaining device of claim 21 (See above rejection of claim 21), in the compressed configuration, into a lumen of the stent catheter (occlusion device (20) in collapsed condition inserted into catheter lumen (11); Figure 2 and Paragraph [0042]);
sliding the retaining device along the lumen toward the open end of the stent catheter (delivery tube (14) advances the device through the lumen; Paragraph [0043]); and
transitioning the retaining device into the relaxed configuration as the retaining device emerges from the open end of the stent catheter, thereby expanding the retaining device outward into the aneurysmal sac (device expands from compressed state to hemi-spherical relaxed configuration upon exiting the catheter distal end into sac (S); Figures 2-3 and Paragraph [0043]).
Regarding claim 38, Lorenzo further discloses, further comprising:
sliding an endovascular coil into the aneurysmal sac through an opening in the expanded retaining device (embolic coil (40) advanced through inner passage (26) of the expanded of the expanded control ring/netting after the device is deployed; Figure 4 and Paragraph [0044]); and
intertwining the endovascular coil with netting of the retaining device within the aneurysmal sac (the coil fills the sac and anchors by mechanically intertwining/entangling with the braided mesh netting; Paragraph [0044] in view of paragraph [0048]).
Regarding claim 39, Lorenzo further discloses, wherein:
the netting of the retaining device is in an expanded netting shape that includes a plurality of fingers (braided filament extensions as mapped in claim 28 earlier);
at least some of the plurality of fingers form one or more loops (braided filament crossings and enclosures as mapped in claim 33 earlier); and
intertwining the endovascular coil with the netting of the retaining device within the aneurysmal sac includes intertwining with the one or more loops (the coil is advanced into the sac and fills/expands such that it passes through and entangles with the loop-like filament structures of the braided netting; Paragraph [0044] in view of paragraph [0048]).
Regarding claim 40, Lorenzo discloses, an intrasaccular stent device for aneurysm treatment (Figures 1-6, delivery system (10); Paragraph [0041]), comprising:
retaining means for fitting within and sliding along a lumen of a catheter in a compressed configuration, and for expanding outward into an aneurysmal sac in a relaxed configuration, thereby covering an inner mouth of the aneurysmal sac (Figures 1-6, occlusion device (20) with its braided mesh structure (25)/body (24) is compressed to slide through lumen (11) of microcatheter (12), then self-expands upon emergence into a hemi-spherical shape that conforms to and covers the inner mouth/neck (N) from within the sac (S); Paragraphs [0042]-[0044] and [0048]; the structure performs exactly the recited functions).
Response to Arguments
Applicant’s arguments with respect to newly filed claim(s) 21 and 40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The new ground(s) of rejection rely on Lorenzo (US PGPUB No. 20190008522 A1) which is different from the references applied in the prior rejection of record (Connor (US 20210219986 A1), Babiker (US 20190251866 A1), and Chen (US 20130184743 A1)). The arguments specifically challenged teachings in the prior art of record in view of the newly filed claims. However, the new ground(s) of rejection do not rely on Connor, Babiker, or Chen for any teachings or matter or matter challenged in the arguments. Therefore, the arguments are moot and do not apply to the new ground(s) of rejection. See MPEP 1207.02(A)(2) (Arguments not commensurate with the rejection will not be considered persuasive).
See updated rejections above.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771