DETAILED ACTION
Claims 1-10, 14-17, and 22 are canceled. Claims 20-21 and 23-25 are amended. Claims 61-75 are newly added claims. A complete action on the merits of pending claims 20-21, 23-25, and 61-75 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/26/2025 has been entered.
Response to Amendment
Acknowledgment is made to applicant's amendments filed on 11/26/2025. The 35 USC 112(b) rejection documented in the Final Office Action sent on 07/02/2025 is overcome in light of the applicant’s cancelation of claim 15 and is withdrawn.
Claim Objections
Claim 63 is objected to because of the following informalities:
Claim 63 should be amended to the following to maintain consistency and avoid ambiguity, “The system of claim 62, wherein the length of hypotube material comprises:
a distal segment defining the distally-facing end surface, wherein the distally-facing end surface provides a coplanar end surface for at least 270 degrees around a circumference;
a tubular proximal segment; and
an intermediate segment between the distal segment and the tubular proximal segment.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 66 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.
The term “about” in claim 66 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, and the specification does not provide an objective standard (such as a stated tolerance, percentage variation, measurement precision, or clinical/functional bounds relevant to aneurysm treatment) for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention with reasonable certainty (MPEP 2173.05(b); see also Ecolab v. Envirochem, Inc., 264 F.3d 1358 (Fed. Cir. 2001); Ortho-McNeil Pharm., LLC v. Caraco Pharm. Labs, Ltd., 476 F.3d 1321 (Fed. Cir. 2007)). The term “about” in “the range of about 1 mm to about 5 mm” renders the claim indefinite by failing to clearly define boundaries of the range. The specification uses similar language (Page 15, line 20-Page 16, line 9) but provides no objective standard or tolerance for “about,” leaving one of ordinary skill unable to determine the metes and bounds. While “about” may be definite in some contexts where the specification, prosecution history, or knowledge in the art supplies clear bounds (e.g., manufacturing tolerances or functional equivalence in aneurysm coil delivery), no such context is provided here.
Applicant must amend to remove “about” or otherwise clarify the range (e.g., by reciting a closed numerical range without “about,” or by defining “about” with a specific tolerance such as ±10% or ±0.25mm).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 20, 23, 25, 61-62, and 67-69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balgobin (US PGPUB No. 20060276830 A1).
Regarding claim 20, Balgobin discloses, an embolic coil device (Figure 1, embolic device (23); Paragraph [0029]) for detachable connection to an elongate delivery shaft (Figure 1, pusher member (16); Paragraph [0028]) of an embolic coil delivery system (Figures 1 and 3, deployment system (10) with sheath introducer (12) or delivery catheter (35); Paragraphs [0028] and [0037]), comprising:
an embolic coil (embolic device (23); Paragraph [0029], “The deployment system 10 also includes an embolic device 23, which as illustrated, preferably takes the form of a helically wound embolic coil …”) including coil windings having a longitudinally extended condition in a relaxed condition of the embolic coil device (Paragraphs [0031]-[0035], coil windings extend longitudinally in relaxed/deployed state after release; Figures 2C-2D and 3B-3C, where coil is released and assumes relaxed shape; Paragraph [0006], inherent in radiopaque metallic helical coil (e.g., platinum) that elastically returns to extended/open state post compression), the coil windings being resiliently compressible to a longitudinally compressed condition (Paragraphs [0031]-[0036], proximal windings compressible/closable when engaged/retained under tension by engagement member (18) and detachment member (30), resiliently expand upon release; Figures 2A-2D, where proximal turn/retaining ring (28) is held compressed/engaged, then lifted/released; Paragraphs [0006] and [0029], inherent resiliency of helical coil material), wherein the coil windings in the longitudinally extended condition are more open than they are in the longitudinally compressed condition (Paragraphs [0029] and [0035]-[0036]; inevitable behavior of a helical coil under preload vs. unloaded state, as the windings must space apart upon removal of compressive retention force to achieve the relaxed deployed configuration shown in the figures (MPEP § 2112; PAR Pharm., Inc. v. TWI Pharms., Inc. (773 F.3d 1186, Fed. Cir. 2014))); and
a retention member (Figure 1, retaining ring (28) on headpiece (21); Paragraph [0029]) including a filament material (Figures 1/1A, stretch resistant member (25/27) (platinum wire/filament); Paragraphs [0029]-[0030]) extending distally through a lumen of the embolic coil (Figures 1/1A; Paragraph [0029]) and attached to a distal end of the embolic coil (Paragraphs [0029]-[0030], attached to distal bead (24)) and wherein the retention member is configured to facilitate a detachable connection of the embolic coil device to the shaft (Figures 1-2D; Paragraphs [0028]-[0031], retaining ring (28) engages L-shaped engagement member (18) on pusher (16), detachable via proximal withdrawal of detachment member (30) from aperture (22)) in which the filament material provides stretch resistance to the embolic coil (Stretch resistant member 25/27 prevents coil stretching/elongation during withdrawal or repositioning; Paragraph [0036], states, “… the embolic device may be withdrawn without concern that the coil will stretch and become very difficult to remove.”).
Regarding claim 23, Balgobin further discloses, wherein the retention member includes a loop attached to the filament material (Figures 1; Paragraph [0029], retaining ring (28) is a loop extending proximally from headpiece (21), and the proximal end of the stretch-resistant member (25) (filament) is attached to the distal edge of the headpiece (21), thus the loop is attached to the filament material via the headpiece. Alternatively, in the Figure 1A embodiment and the disclosure of Paragraph [0030], stretch resistant member (27) is attached to proximal turns by bead (29), and the proximal end of the coil (including retention features) is attached to the retaining ring (loop)).
Regarding claim 25, Balgobin further discloses, wherein said coil windings are of a first winding segment, the first winding segment including only a portion of the coil windings of the embolic coil (Figures 1/1A and 2A-2D; Paragraphs [0029]-[0030] and [0035]-[0038], the proximal section of the coil includes specific windings/turns attached to the headpiece (21) or bead (29) (Figure 1A), forming a proximal winding segment that is resiliently engaged/compressed under retention and expands upon release; this proximal segment is only a portion of the overall helical coil windings, as the coil has distal, middle, and proximal sections with the proximal turns specifically involved in the retention/compression; inherent in the proximal turns being held and released separately from the full coil length).
Regarding claim 61, Balgobin further discloses, wherein said coil windings constitute all coil windings of the embolic coil (Paragraph [0029], the embolic device (23) is a helically wound coil with windings extending the full length from proximal to distal; the resilient compression/extension behavior applies to the entire coil, as the stretch-resistant member (25/27) runs through the full lumen, preventing overall stretching but allowing inherent resilient compression/expansion of all windings upon engagement/release. Further, Figures 1/1A, 2C-2D, and 3B-3C along with Paragraphs [0035]-[0038], where the full coil assumes relaxed/extended shape post-release).
Regarding claim 62, Balgobin discloses, a system for delivering an embolic coil device (Figures 1 and 3, deployment system (10) with sheath introducer (12) or delivery catheter (35); Paragraphs [0028] and [0037]), comprising:
an embolic coil device (Figure 1, embolic device (23); Paragraph [0029]) comprising:
an embolic coil (embolic device (23); Paragraph [0029], “The deployment system 10 also includes an embolic device 23, which as illustrated, preferably takes the form of a helically wound embolic coil …”) including coil windings having a longitudinally extended condition in a relaxed condition of the embolic coil device (Paragraphs [0031]-[0035], coil windings extend longitudinally in relaxed/deployed state after release; Figures 2C-2D and 3B-3C, where coil is released and assumes relaxed shape; Paragraph [0006], inherent in radiopaque metallic helical coil (e.g., platinum) that elastically returns to extended/open state post compression), the coil windings being resiliently compressible to a longitudinally compressed condition (Paragraphs [0031]-[0036], proximal windings compressible/closable when engaged/retained under tension by engagement member (18) and detachment member (30), resiliently expand upon release; Figures 2A-2D, where proximal turn/retaining ring (28) is held compressed/engaged, then lifted/released; Paragraphs [0006] and [0029], inherent resiliency of helical coil material), wherein the coil windings in the longitudinally extended condition are more open than they are in the longitudinally compressed condition (Paragraphs [0029] and [0035]-[0036]; Inherent in helical coil, where windings are more spaced/open in unloaded/relaxed extended state post-release vs. close/compressed under retention preload/force during attachment; standard behavior of helical coils in delivery systems), and
a retention member (Figure 1, retaining ring (28) on headpiece (21); Paragraph [0029]) including a filament material (Figures 1/1A, stretch resistant member (25/27) (platinum wire/filament); Paragraphs [0029]-[0030]) extending distally through a lumen of the embolic coil (Figures 1/1A; Paragraph [0029]) and attached to a distal end of the embolic coil (Paragraphs [0029]-[0030], attached to distal bead (24));
a flexible elongate delivery shaft (Figures 1 and 3, pusher member (16) slidably disposed in sheath introducer (12) or delivery catheter (35); Paragraphs [0028] and [0037]) defining a shaft lumen (Figures 1-3C, lumen in pusher member (16); Paragraph [0031]) and having a distal region (Figures 1-2D, distal end with engagement member (18) and kicker member (17); Paragraphs [0028] and [0031]), the distal region including a detachment interface including a length of tubular material attached to an adjacent segment of the elongate delivery shaft (Pusher member (16) is a flexible elongated tubular member formed with a wall from which engagement member (18) and kicker member (17) are cut/integral (Paragraphs [0028] & [0031]), providing sufficient column strength and pushability typical of hypotube-like construction in the art; Paragraph [0028] describes pusher (16) as elongated flexible (Paragraph [0016], known in the art) member; Engagement member (18) and kicker member (17) are features formed by cutting from the distal wall of pusher (16)), the length of tubular material defining a distally-facing end surface at a distal end of the elongate delivery shaft (distal end of pusher (16)/tubular structure inherently provides a distally-facing annular/partial circumferential end surface or abutment face from which engagement member (18) and kicker (17) extend; this surface faces distally and serves as a stop/abutment for proximal coil end/headpiece (21) under compression; Figures 2A-2B illustrate proximal coil retention against distal pusher end);
a pull wire (Figure 1, detachment member (30) (elongated filament/wire)) extending distally through the shaft lumen (Paragraphs [0031]-[0032]), the pull wire having a distal end positioned distal to the distal end of the elongate delivery shaft (Figures 2A-2B; detachment member (30) extends through aperture (22) and beyond distally to interlock retaining ring (28); distal end positioned distal to pusher distal end during locked state);
wherein a proximal end of the embolic coil abuts the distally-facing end surface of the length of tubular material (proximal end of coil/headpiece (21) with retaining ring (28) abuts/engages against the distally facing end surface of pusher (16) distal tubular region under retention preload/compression. Figures 2A-2B show contact/abutment for transmitting push force during deployment and maintaining compression during retention (Paragraph [0035));
wherein the pull wire interfaces with the retention member in a detachable connection of the embolic coil device to the distal region of the elongate delivery shaft (Paragraphs [0031]-[0032], detachment member (30) interfaces with retaining ring (28) by extending therethrough and through aperture (22) of engagement member (18)) in which the filament material of the embolic coil device provides stretch resistance to the embolic coil (Paragraph [0036], stretch-resistant member (25/27) prevent coil stretching during manipulation/repositioning/withdrawal); and
wherein proximal retraction of the pull wire detaches the embolic coil device from the distal region of the elongate delivery shaft (Figures 2C-2D and 3B; Paragraphs [0033]-[0035], proximal retraction of detachment member (30) withdraws it from aperture (22), disengaging retaining ring (28) from engagement member (18) and allowing kicker (17) to assist release).
Regarding claim 67, Balgobin discloses, a system for delivering an embolic coil device (Figures 1 and 3, deployment system (10) with sheath introducer (12) or delivery catheter (35); Paragraphs [0028] and [0037]), comprising:
a flexible elongate delivery shaft (Figures 1 and 3, pusher member (16) slidably disposed in sheath introducer (12) or delivery catheter (35); Paragraphs [0028] and [0037]) defining a shaft lumen (Figures 1-3C, lumen in pusher member (16); Paragraph [0031]) and having a distal region (Figures 1-2D, distal end with engagement member (18) and kicker member (17); Paragraphs [0028] and [0031]), the distal region including a detachment interface including a length of tubular material attached to an adjacent segment of the elongate delivery shaft (Pusher member (16) is a flexible elongated tubular member formed with a wall from which engagement member (18) and kicker member (17) are cut/integral (Paragraphs [0028] & [0031]), providing sufficient column strength and pushability typical of hypotube-like constructions in the art; Paragraph [0028] describes pusher (16) as elongated flexible (Paragraph [0016], known in the art) member; Engagement member (18) and kicker member (17) are features formed by cutting from the distal wall of pusher (16)), wherein the length of tubular material defines a distally-facing end surface at a distal end of the elongate delivery shaft (distal end of pusher (16)/tubular structure inherently provides a distally-facing annular/partial circumferential end surface or abutment face from which engagement member (18) and kicker (17) extend; this surface faces distally and serves as a stop/abutment for proximal coil end/headpiece (21) under compression; Figures 2A-2B illustrate proximal coil retention against distal pusher end);
a pull wire (Figure 1, detachment member (30) (elongated filament/wire)) extending distally through the shaft lumen (Paragraphs [0031]-[0032]), the pull wire having a distal end positioned distal to the distal end of the elongate delivery shaft (Figures 2A-2B; detachment member (30) extends through aperture (22) and beyond distally to interlock retaining ring (28); distal end positioned distal to pusher distal end during locked state);
an embolic coil device (Figure 1, embolic device (23); Paragraph [0029]) detachably connected to the distal region of the elongate delivery shaft (The embolic coil device (23) is detachably connected to the distal region of the elongate delivery shaft (pusher member (16)) via interlocking of the retention member (retaining ring (28)/loop on headpiece (21)) with the detachment interface (engagement member (18) through ring (28), secured by pull wire (30) through aperture (22); Paragraphs [0031]-[0032]; Figures 2A-2B, connected state). Proximal retraction of the pull wire releases the connection (withdraws (30) from aperture (22), disengaging ring (28) from (18); Paragraphs [0033]-[0035]; Figures 2C-2D)) and including:
an embolic coil (embolic device (23); Paragraph [0029], “The deployment system 10 also includes an embolic device 23, which as illustrated, preferably takes the form of a helically wound embolic coil …”) including coil windings defining a coil lumen within the coil windings (Figures 1/1A, central lumen through windings; Paragraph [0029]); and
a retention member (Figure 1, retaining ring (28) on headpiece (21); Paragraph [0029]) including a filament material (Figures 1/1A, stretch resistant member (25/27) (platinum wire/filament); Paragraphs [0029]-[0030]), with the filament material extending distally through the coil lumen (Figures 1/1A; Paragraph [0029]) and attached to a distal end of the embolic coil (Paragraphs [0029]-[0030], attached to distal bead (24));
wherein a proximal end of the embolic coil abuts the distally-facing end surface of the length of tubular material (proximal end of coil/headpiece (21) with retaining ring (28) abuts/engages against the distally facing end surface of pusher (16) distal tubular region under retention preload/compression. Where Figures 2A-2B show inherent contact/abutment for transmitting push force during deployment and maintaining compression during retention (Paragraph [0035));
wherein the filament material provides stretch resistance to the embolic coil while the embolic coil device is detachably connected to the distal region of the elongate delivery shaft (Paragraph [0036], stretch-resistant member (25/27) prevents stretching during connected manipulation/repositioning/withdrawal);
wherein the pull wire interfaces with the retention member in the distal region of the elongate delivery shaft (Paragraphs [0031]-[0032], detachment member (30) interfaces with retaining ring (28) by extending therethrough and through aperture (22)); and
wherein proximal retraction of the pull wire detaches the embolic coil device from the distal region of the elongate delivery shaft (Figures 2C-2D and 3B; Paragraphs [0033]-[0035], proximal retraction of detachment member (30) withdraws it from aperture (22), disengaging retaining ring (28) from engagement member (18) and allowing kicker (17) to assist release).
Regarding claim 68, Balgobin further discloses, wherein the distal end of the pull wire is positioned within the coil lumen (Figures 2A-2B; Paragraph [0031], distal end of detachment member (30) is positioned distal to pusher end and extends into/through the proximal portion of the coil lumen to pass through retaining ring (28) during locked state).
Regarding claim 69, Balgobin further discloses, wherein the retention member includes a loop attached to the filament material (Figures 1; Paragraph [0029], retaining ring (28) is a loop extending proximally from headpiece (21), and the proximal end of the stretch-resistant member (25) (filament) is attached to the distal edge of the headpiece (21), thus the loop is attached to the filament material via the headpiece. Alternatively, in the Figure 1A embodiment and the disclosure of Paragraph [0030], stretch resistant member (27) is attached to proximal turns by bead (29), and the proximal end of the coil (including retention features) is attached to the retaining ring (loop)).
Claim Rejections - 35 USC § 103
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balgobin, in view of Palermo (US Patent No. 5350397 A).
Regarding claim 21, Balgobin teaches, the retention member (retaining ring (28) on headpiece (21)) for detachable connection (Paragraph [0029]).
Balgobin does not explicitly disclose, wherein the retention member includes a ball attached to the filament material, bead (24) is described as a weld or solder bead providing an atraumatic tip and attached to the stretch-resistant member (25/27) at the distal end (Paragraph [0029]); however, bead (24) is not expressly ball-shaped or the primary retention interface for detachment. However, in the “Background of Invention” section at paragraph [0009], Balgobin cites to US Patent No. 5350397 A indicating that ball-based retention members are known equivalents in the art for coil detachment.
Palermo discloses, a device for delivering an embolic coil. Palermo teaches, a ball (Figure 1, ball (104)) on the coil proximal end (Figure 1, coil (102)) is retained in a socket (Figure 1, socket (108)) and released by pusher (Figure 1, pusher wire (114)) (Col. 4, line 22-48).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Balgobin’s retention member to include a ball attached to the filament material, as taught by Palermo (the prior art cited in Balgobin), as both references and the claimed invention are directed to systems for delivering embolic coils. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Balgobin’s retention member to include a ball attached to the filament material, as taught by Palermo (the prior art cited in Balgobin), as such a modification would have been predictable, namely, substituting a ball for a ring is a simple substitution of one known retention element for another to obtain predictable results (i.e., secure detachable connection via interference fit or socket, improving manufacturability or release reliability in embolic coil systems; KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Claim(s) 24, 63-66 and 70-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balgobin.
Regarding claim 24, Balgobin discloses, the retention member includes a loop (retaining ring (28)), but the loop is integrated with headpiece (21) rather than defined by a portion of the filament material itself (Paragraphs [0029-[0030]; Figures 1/1A shows retaining ring (28) as a separate/proximal loop structure attached to headpiece (21), with stretch-resistant filament (25/27) extending distally through the coil and attached at the distal end to bead (24), while proximal filament end attached to headpiece/distal edge).
It would have been obvious to one of ordinary skill in the art before the effective filing date to form the loop directly from a portion of the filament material (e.g., by bending or shaping the proximal end of the stretch-resistant filament (platinum wire) into a loop or eyelet for engagement with the detachment mechanism), instead of using a separate retaining ring attached to a headpiece. This represents a predictable variation and routine modification of the disclosed structure: the filament is already a metallic wire capable of being formed into small loops or attachment features (as inherently known for platinum wire in vaso-occlusive devices), the function remains the same (providing a proximal engagement loop for the pull-wire/detachment interface), the function remains the same (providing a proximal engagement loop for the pull-wire/detachment interface), and no new or unexpected results arise). A POSITA would recognize this as a simple design choice to simplify manufacturing (fewer components) or improve integration, consistent with KSR Int’l Co. v. Teleflex Inc.(predictable use of prior art elements according to their established functions.
Regarding claims 63, Balgobin discloses the distal tubular region of pusher member (16) with cut features for engagement member (18) and kicker (17) (Paragraphs [0028], [0031]; Figures 1-2D), inherently providing a distally-facing end surface after selective cutting of detachment features. Balgobin does not explicitly disclose wherein the length of hypotube/tubular material comprises: a distal segment defining the distally-facing end surface, a tubular proximal segment, and an intermediate segment between them (with the surface providing a coplanar end surface for at least 270 degrees around a circumference).
It would have been obvious to one of ordinary skill in the art before the effective filing date to configure the distal tubular/hypotube region to include such distinct segments (distal intact segment defining the abutment surface, proximal unmodified tubular segment, and intermediate cut/modified segment for engagement/kicker features), as this represents routine structural organization of a laser-cut or machined tubular pusher distal end. The unmodified distal tip/rim inherently provides a coplanar abutment face for the proximal coil end/headpiece (21), and a POSITA would retain a majority circumferential coplanar rim (accounting for at least 270 degrees, typically near 360 degrees minus localized cuts) to ensure structural integrity, reliable force transmission/abutment during retention and push, and accommodation of necessary cutouts—routine optimization of a result-effective variable in delivery system design (In re Aller, 220 F.2d 454 (CCPA 1955)). Balgobin’s aneurysm deployment context (Paragraph [0037]) reinforces the need for a compact, precise distal working end compatible with microcatheters and tortuous vasculature.
Regarding claim 64, Balgobin discloses, wherein the tubular proximal segment of the length of tubular material is attached to the adjacent segment of the elongate delivery shaft (the unmodified tubular proximal segment of the distal tubular region is inherently continuous with and attached to the adjacent proximal portion of pusher member (16) as a unitary tubular structure; Paragraph [0028] describes pusher member (16) as an elongated flexible tubular member with a lumen; Paragraphs [0028] and [0031] shows the distal cut features formed from the wall of the same pusher member, confirming the distal tubular length is integrally attached/continuous with the proximal shaft segment without requiring a separate joint in the disclosed embodiment).
Regarding claim 65, Balgobin discloses the claimed invention except for, “wherein the length of hypotube material has a longitudinal length of no greater than 10 mm.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the length of the distal tubular/hypotube material to be no greater than 10 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. Balgobin reinforces this by describing deployment into an aneurysm (Paragraph [0037]), which inherently requires a compact distal working length (typically millimeters) for compatibility with microcatheters, flexibility in tortuous intracranial vasculature, and precise positioning/release without excessive stiffness or protrusion. In re Aller.
Regarding claim 66, as best understood in view of the 112b issues noted above, Balgobin discloses the claimed invention except for, “wherein the longitudinal length is in the range of about 1 mm to about 5 mm.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the length of the distal hypotube material in the range of about 1 mm to about 5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. Balgobin further supports this by disclosing precise aneurysm deployment (Paragraphs [0037]-[0038]) and the need for a minimal distal working length to maintain flexibility, reliable cut-feature integrity (engagement member (18) and kicker (17); Paragraph [0031]), and controlled release without compromising pushability or catheter compatibility. In re Aller.
Regarding claim 70, Balgobin discloses as above (distal end surface of pusher (16) providing distally-facing annular/partial circumferential abutment; Figures 2A-2B). It would have been obvious to configure the distally-facing end surface to provide a coplanar end surface for at least 270 degrees around a circumference, as a POSITA would retain a substantial circumferential coplanar rim (typically ≥270 degrees after minor localized cuts for engagement/kicker) for effective abutment and push-force transmission while allowing functional cut features—predictable optimization of geometry in tubular detachment interfaces. In re Aller.
Regarding claim 71, Balgobin as modified above discloses the surface as coplanar for at least 270 degrees. It would have been obvious for the coplanar end surface to be continuous for the at least 270 degrees around a circumference, as a POSITA would minimize interruptions in the annular face (keeping the majority continuous except at discrete cut locations) to maximize abutment contact area and structural support—routine design choice yielding predictable improvements in retention stability (In re Aller; KSR).
Regarding claim 72, Balgobin as modified above discloses the surface as coplanar for at least 270 degrees. It would have been obvious for the coplanar end surface to be discontinuous for the at least 270 degrees around a circumference (e.g., where cuts for engagement member (18) and kicker (17) create discrete interruptions, but the remaining coplanar portions collectively span ≥270 degrees), as this is an inherent/inevitable result of forming cut detachment features from the tubular wall while preserving sufficient abutment surface—predictable accommodation of functional requirements in the art (KSR; In re Aller for resulting geometry).
Regarding claims 73, Balgobin discloses the distal tubular region of pusher member (16) with cut features for engagement member (18) and kicker (17) (Paragraphs [0028], [0031]; Figures 1-2D), inherently providing a distally-facing end surface after selective cutting of detachment features. Balgobin does not explicitly disclose wherein the length of hypotube/tubular material comprises: a distal segment defining the distally-facing end surface, a tubular proximal segment, and an intermediate segment between them (with the surface providing a coplanar end surface for at least 270 degrees around a circumference).
It would have been obvious to one of ordinary skill in the art before the effective filing date to configure the distal tubular/hypotube region to include such distinct segments (distal intact segment defining the abutment surface, proximal unmodified tubular segment, and intermediate cut/modified segment for engagement/kicker features), as this represents routine structural organization of a laser-cut or machined tubular pusher distal end. The unmodified distal tip/rim inherently provides a coplanar abutment face for the proximal coil end/headpiece (21), and a POSITA would retain a majority circumferential coplanar rim (accounting for at least 270 degrees, typically near 360 degrees minus localized cuts) to ensure structural integrity, reliable force transmission/abutment during retention and push, and accommodation of necessary cutouts—routine optimization of a result-effective variable in delivery system design (In re Aller, 220 F.2d 454 (CCPA 1955)). Balgobin’s aneurysm deployment context (Paragraph [0037]) reinforces the need for a compact, precise distal working end compatible with microcatheters and tortuous vasculature.
Regarding claim 74, Balgobin discloses, wherein the tubular proximal segment of the length of tubular material is attached to the adjacent segment of the elongate delivery shaft (the unmodified tubular proximal segment of the distal tubular region is inherently continuous with and attached to the adjacent proximal portion of pusher member (16) as a unitary tubular structure; Paragraph [0028] describes pusher member (16) as an elongated flexible tubular member with a lumen; Paragraphs [0028] and [0031] shows the distal cut features formed from the wall of the same pusher member, confirming the distal tubular length is integrally attached/continuous with the proximal shaft segment without requiring a separate joint in the disclosed embodiment).
Regarding claim 75, Balgobin discloses the claimed invention except for, “wherein the length of hypotube material has a longitudinal length of no greater than 10 mm.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the length of the distal hypotube material to be no greater than 10 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. Balgobin reinforces this by describing deployment into an aneurysm (Paragraph [0037]), which inherently requires a compact distal working length (typically millimeters) for compatibility with microcatheters, flexibility in tortuous intracranial vasculature, and precise positioning/release without excessive stiffness or protrusion. In re Aller.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20-21 and 23-25 have been considered but are moot because the rejections now rely primarily on Balgobin (US PGPUB No. 20060276830 A1) (with Palermo (US Patent No. 5350397 A) cited only for claim 21 under § 103), and do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The updated mappings and rationales above address the teachings of Balgobin directly (including inherency where inevitable, or obviousness where optimization or substitution applied), rendering prior argument non-responsive to the current grounds.
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