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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
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 20 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 20 recites the limitation "the elongate body" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be presumed to refer to the proximal elongate shaft.
Claim Rejections - 35 USC § 103
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 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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0298396 A1 to Gamba et al. (hereinafter “Gamba”) in view of US 2003/0144689 A1 to Brady et al. (hereinafter “Brady”) (both references previously of record).
Regarding claim 1, Gamba discloses (see abstract; Figs. 1-14; and [0103]-[0198]) a catheter (Figs. 8A-B, [0175]-[0176]) comprising: a proximal elongate shaft (small diameter portion 12 of container element 4 extending proximally in Fig. 1, see [0104] and [0132]-[0133]) comprising a longitudinal axis (shown in Fig. 1 as “LA”), a distal end (shown in Figs. 1 and 8A-B), a lumen (24, see [0104]), a proximal elongate shaft center (see Examiner’s Diagram of Figs. 8A/B below) and a shaft braid (see [0122]-[0126]); and an expandable distal tip section (4) at the distal end of the elongate shaft (as shown in Fig. 8B), the expandable distal tip section comprising a collapsed delivery configuration (shown in Fig. 8A, see also [0105]), an expanded deployed configuration (shown in Fig. 8B, and also [0109]/[0110]/[0115]), a tip braid (see [0124]-[0125 and Figs. 8A-B), a proximal end attached to the distal end of the proximal elongate shaft (see Fig. 1; [0104] and [0132]-[0133]), an expandable distal tip section center (see Examiner’s Diagram of Figs. 8A/B below), and a distal mouth comprising a beveled profile (62, Fig. 8B), wherein a profile of the expandable distal tip section is substantially symmetric with respect to the longitudinal axis when in the collapsed delivery configuration, but asymmetric or offset when in the expanded deployed configuration (see Examiner’s Diagram of Figs. 8A/B below), wherein in the expanded deployed configuration, at least a portion of the expandable distal tip section is longitudinally offset from the longitudinal axis, such that the expandable distal tip section center migrates radially away from being concentric with the proximal elongate shaft center (see Examiner’s Diagram of Figs. 8A/B below, the black vertical bars show the expandable distal tip section center and the proximal elongate shaft center, the proximal elongate shaft center is concentric with the long. axis (shown in dashed line) but the expandable distal tip section center is shown offset from the long. axis as it has migrated towards the left in Fig. 8B, thus it is longitudinally offset from the longitudinal axis because it has migrated radially away and is no longer concentric with the proximal elongate shaft center).
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Gamba fails to specifically disclose a perimeter defined by a reinforcing ring; wherein the reinforcing ring comprises a plurality of relief features spaced equally around the longitudinal axis. Brady teaches (see Fig. 48 and [0258]-[0260] a perimeter (Fig. 48) defined by a reinforcing ring (support 215; Fig. 48); the reinforcing ring (support 215; Fig. 48) comprising a plurality of relief features (loops 120; Fig. 48, [0259]-[0260]) spaced equally (Fig. 48-49) around the longitudinal axis (Fig. 48). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention to modify Gamba’s catheter tip section to include Brady’s reinforcing ring with a plurality of relief features be disposed around the tip section in order to enhance the ability to be wrapped or collapsed down to a low profile as taught in Brady ([0259]-[0260]).
With respect to claim 2, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the expandable distal tip section further comprising a substantially circular cross section in both the collapsed delivery configuration and expanded deployed configuration (Gamba: see Figs. 8A-B, a cross-section taken at #4 in each Figure would be circular, see also [0125]).
With respect to claims 3-4, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the reinforcing ring is welded/overmolded to the tip braid of the expandable distal tip section (the combination would result in the reinforcing ring being “attached” to the tip braid, but would be silent as to the particular technique for attaching - the claimed phrases “welded and overmolded” are being treated as product by process limitations. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the applicant that the process of being weld or overmolded imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitations “welded and overmolded” are given little patentable weight. Moreover, the Examiner official notice that welding or overmolding is a well-known method in the art to secure a support ring or frame to mesh. Therefore, it is obvious for one skilled in the art to use the well-known method to secure the reinforcing ring of Brady to the distal tip section of Gamba.
With respect to claim 5, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the reinforcing ring comprises a shape memory alloy (Brady: [0258]-[0259])
With respect to claim 6, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the reinforcing ring is heat set to comprise an expanded inner diameter larger than a collapsed inner diameter when the distal tip section is in the expanded deployed configuration (the combination’s device would have the reinforcing ring to be larger in an expanded configuration than a collapsed configuration (i.e., the reinforcing ring of Brady added to Gamba would encircle the distal tip perimeter of Gamba and as shown in Figs. 8A/B of Gamba the expanded deployed configuration has an expanded distal tip inner diameter larger than a collapsed distal tip inner diameter; moreover, the phrase “heat set” is also interpreted as a product by process limitation as set forth above in claims 3-4; additionally, Gamba discloses the technique of heat-setting at [0125]).
With respect to claim 7, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose (as per Gamba) wherein at least a portion of the tip braid is heat set to comprise an expanded inner diameter larger (Fig. 8B) than a collapsed inner diameter (Fig. 8A) when the expandable distal tip section is in the expanded deployed configuration (see Figs. 8A-B; moreover, the phrase “heat set” is also interpreted as a product by process limitation as set forth above in claims 3-4; additionally, Gamba discloses the technique of heat-setting at [0125]).
With respect to claim 8, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose (as per Brady) wherein the reinforcing ring comprises a polymeric composition (see [0322]-[0324], the nitinol wire of the support wire can be embedded within a polymeric jacket in order to house a radiopaque material for visualization).
With respect to claim 9, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the tip braid is cut to follow the contours of the relief features at the distal end of the expandable distal tip section (Gamba discloses that the tip braid is cut to follow the contours of the distal end of the tip section (as shown in Fig. 8B) – it follows that the reinforcing ring with its contours as added to Gamba would also have the tip braid cut to follow the contours of the relief features (as opposed to having too little or too much mesh material at the reinforcing ring); and further, optimizing the braid helps to enhance the ability to be wrapped or collapsed down to a low profile as taught in Brady’s [0260]).
With respect to claim 10, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the distal mouth defines a plane passing through at least a portion of the reinforcing ring, the plane forming an acute angle with respect to the longitudinal axis when the expandable distal tip section is in the collapsed delivery configuration (as shown in Fig. 8A and [0175], the distal mouth is shown defining an acute plane with respect to the long. axis, and thus would also have the plane passing through a portion of the reinforcing ring in the resultant combination).
With respect to claim 11, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the angle is between approximately 30 degrees and approximately 60 degrees (30 degrees, see [0175]).
With respect to claim 12, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein at least a portion of the relief features of the reinforcing ring is located offset proximally from the plane (see Brady Figs. 40/48, the relief features extend proximally from a plane defined by the rest of the reinforcing ring, and thus in the resultant combination a portion of the relief features would be offset from the plane).
With respect to claim 13, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the relief features reduce the cross sectional profile of at least a portion of the expandable distal tip section (Brady: [0259]; Figs. 48-49).
With respect to claim 14, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the relief features comprise a keyhole shape having a parallel section and a rounded section (Brady: Figs. 8A/48/49).
With respect to claim 15, the combination of Gamba and Brady, as discussed above for the reasons sets forth above, would further disclose wherein the relief features comprise axial slots extending proximally from the distal perimeter of the distal mouth (Brady: see Figs. 8A/40/48/49, negative space within loop 120 defines an axial slot extending proximally from the distal perimeter or rest of the frame 116).
Claim(s) 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gamba in view of Brady and US 2018/0235644 A1 to Jaffe et al. (hereinafter “Jaffe”) (previously of record).
Regarding claim 16, Gamba discloses (see abstract; Figs. 1-14; and [0103]-[0198]) a catheter (Figs. 8A-B, [0175]-[0176]) comprising: a proximal elongate shaft (small diameter portion 12 of container element 4 extending proximally in Fig. 1, see [0104] and [0132]-[0133]) comprising a longitudinal axis (shown in Fig. 1 as “LA”), a distal end (shown in Figs. 1 and 8A-B), a lumen (24, see [0104]), a shaft braid (see [0122]-[0126]) and a proximal elongate shaft center (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1); and an expandable distal tip section (4) connected to the distal end of the elongate shaft (as shown in Fig. 8B), the expandable distal tip section comprising a collapsed delivery configuration (shown in Fig. 8A, see also [0105]), an expanded deployed configuration (shown in Fig. 8B, and also [0109]/[0110]/[0115]), a supporting tip braid (see [0124]-[0125 and Figs. 8A-B), a proximal end attached to the distal end of the proximal elongate shaft (see Fig. 1; [0104] and [0132]-[0133]) an expandable distal tip section center (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1), and a distal mouth comprising a beveled profile (62, Fig. 8B), a mouth plane forming an acute angle with respect to the longitudinal axis when the expandable distal tip section is in the collapsed delivery configuration (see Fig. 8A and [0175]), wherein a profile of the expandable distal tip section is substantially symmetric with respect to the longitudinal axis when in the collapsed delivery configuration, but asymmetric or offset when in the expanded deployed configuration (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1) wherein in the expanded deployed configuration, at least a portion of the expandable distal tip section is longitudinally offset from the longitudinal axis, such that the expandable distal tip section center migrates radially away from being concentric with the proximal elongate shaft center (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1, the black vertical bars show the expandable distal tip section center and the proximal elongate shaft center, the proximal elongate shaft center is concentric with the long. axis (shown in dashed line) but the expandable distal tip section center is shown offset from the long. axis as it has migrated towards the left in Fig. 8B, thus it is longitudinally offset from the longitudinal axis because it has migrated radially away and is no longer concentric with the proximal elongate shaft center).
Gamba fails to specifically disclose a reinforcing ring attached to the distal end of the tip braid; wherein the reinforcing ring comprises a plurality of relief features spaced equally around the longitudinal axis, wherein at least a portion of the reinforcing ring defines the mouth plane, and wherein at least a portion of each of the relief features is proximally offset from the mouth plane; a marker band at the distal end of the shaft; a polymer tip jacket disposed around the expandable distal tip section,
Brady teaches (see Fig. 48 and [0258]-[0260] a perimeter (Fig. 48) defined by a reinforcing ring (support 215; Fig. 48); the reinforcing ring (support 215; Fig. 48) comprising a plurality of relief features (loops 120; Fig. 48, [0259]-[0260]) spaced equally (Fig. 48-49) around the longitudinal axis (Fig. 48), wherein at least a portion of the reinforcing ring defines a mouth plane, wherein at least a portion of the relief feature is proximally offset from the mouth plane (see Figs. 8A/40/48/49). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention to modify Gamba’s catheter tip section to include Brady’s reinforcing ring with a plurality of relief features be disposed around the tip section in order to enhance the ability to be wrapped or collapsed down to a low profile as taught in Brady ([0259]-[0260]).
Jaffe discloses (see abstract; Fig. 2A-6B; and [0034]-[0062]) a catheter comprising a proximal shaft (16) and an expandable distal tip section (22, see [0061]-[0062]), wherein a polymer tip jacket is disposed around the expandable distal tip section (see [0042]/[0060]) in the same field of endeavor for the purpose of providing a membrane/film that seals a periphery of the expandable distal tip section to allow the device to act as a conduit for suction of blood (see [0042]). Jaffe further discloses a marker band at the distal end of the shaft (see [0055]) for the purpose of assisting in proper placement of the catheter relative to the obstruction (see [0055]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gamba’s device (as modified by Brady above) with the polymer tip jacket and marker band as taught by Jaffe in order to provide a membrane/film that seals a periphery of the expandable distal tip section to allow the device to act as a conduit for suction of blood and to assist in proper placement of the catheter relative to the obstruction.
With respect to claim 17, the combination of Gamba, Brady, and Jaffe, as discussed above for the reasons sets forth above, would further disclose wherein the distal edge of the polymer tip jacket follows the contours of the reinforcing ring (since the polymer tip jacket is melted to collapse over the catheter to form an outer film thereupon (Jaffe: [0060]), then the polymer tip jacket would have its distal edge follow the contours of the reinforcing ring, since it would melt and flow around the reinforcing ring of Brady added to Gamba’s device and then harden).
With respect to claim 18, the combination of Gamba, Brady, and Jaffe, as discussed above for the reasons sets forth above, would further disclose wherein at least a portion of the polymer tip jacket extend distally beyond the contours of the reinforcing ring (since the polymer tip jacket is melted to collapse over the catheter to form an outer film thereupon (Jaffe: [0060]), then the polymer tip jacket would extend distally beyond the contours of the reinforcing ring to encapsulate it, since it would melt and flow around the reinforcing ring of Brady added to Gamba’s device and then harden).
With respect to claim 19, the combination of Gamba, Brady, and Jaffe, as discussed above for the reasons sets forth above, would further disclose wherein the polymer tip jacket has a hardness in a range between approximately 42 Shore A to approximately 72 Shore A, since it would be obvious to one of ordinary skill to set the hardness in that range, because it appears that the device of Gamba (as modified by Brady/Jaffe) would operate equally well with the claimed hardness since the distal end of the catheter and polymer jacket is intended to enter a vessel in the body, with the ability to expand and collapse. Further, applicant places no critically on the range claimed, indicating simply that the length is to be within the claimed ranges. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Gamba (as modified by Brady/Jaffe) to have the hardness of the polymer tip jacket to be between approximately 42 Shore A to approximately 72 Shore A because it appears to be an arbitrary design consideration which fails to patentably distinguish over Gamba (as modified by Brady/Jaffe). Further, the given range is known within the art, see US 2008/0275483 A1 to Makower at [0176], US 2009/0163851 A1 to Holloway at [0121], US 2013/0012925 A1 to Berthiaume at [0020], US 2013/0253343 A1 to Waldhauser at [0095], US 2019/0336727 A1 to Yang et al., etc.
With respect to claim 20, the combination of Gamba, Brady, and Jaffe, as discussed above for the reasons sets forth above, would further disclose wherein the elongate body does not have an axial spine (there is no mention of a spine in Gamba’s disclosure with respect the proximal elongate shaft).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,011,186 B2 in view of Gamba.
Regarding current claim 1, ‘186 patent claim 1 sets forth: A catheter (C14L59) comprising: a proximal elongate shaft comprising a longitudinal axis, a distal end, a lumen, and a shaft braid (C14L60-61); and an expandable distal tip section at the distal end of the elongate shaft, the expandable distal tip section comprising a collapsed delivery configuration, an expanded deployed configuration, a tip braid, and a distal mouth comprising a beveled profile and a perimeter defined by a reinforcing ring (C14L62-67); a proximal end attached to the distal end of the proximal elongate shaft (C15L4-5); wherein the reinforcing ring comprises a plurality of relief features spaced equally around the longitudinal axis (C15L1-2).
Regarding current claim 16, ‘186 patent claim 16 sets forth: A catheter (C16L7) comprising: a proximal elongate shaft comprising a longitudinal axis, a distal end, a lumen, a shaft braid, and a marker band at the distal end of the shaft (C16L8-10); an expandable distal tip section connected to the distal end of the elongate shaft, the expandable distal tip section comprising a collapsed delivery configuration, an expanded deployed configuration, a supporting tip braid, and a reinforcing ring attached to the distal end of the tip braid (C16L11-16); a proximal end attached to the distal end of the proximal elongate shaft (C16L27-28); and a polymer tip jacket disposed around the expandable distal tip section (C16L17-18); wherein at least a portion of the reinforcing ring defines a mouth plane forming an acute angle with respect to the longitudinal axis when the expandable distal tip section is in the collapsed delivery configuration (C16L19-22); wherein the reinforcing ring comprising a plurality of relief features spaced equally around the longitudinal axis, at least a portion of each of the relief features being proximally offset from the mouth plane (C16L23-26)., and wherein a profile of the expandable distal tip section is substantially symmetric with respect to the longitudinal axis when in the collapsed delivery configuration, but asymmetric or offset when in the expanded deployed configuration.
With respect to current claims 1/16, ‘186 patent claims 1 and 16 fail to set forth a proximal elongate shaft center, an expandable distal tip section center, and wherein a profile of the expandable distal tip section is substantially symmetric with respect to the longitudinal axis when in the collapsed delivery configuration, but asymmetric or offset when in the expanded deployed configuration and wherein in the expanded deployed configuration, at least a portion of the expandable distal tip section is longitudinally offset from the longitudinal axis, such that the expandable distal tip section center migrates radially away from being concentric with the proximal elongate shaft center
Gamba discloses (see abstract; Figs. 1-14; and [0103]-[0198]) a catheter (Figs. 8A-B, [0175]-[0176]) comprising: a proximal elongate shaft (8) comprising a longitudinal axis (shown in Fig. 1 as “LA”), a distal end (shown in Figs. 8A-B), a lumen (24, see [0104]), a shaft braid (see [0134]) and a proximal elongate shaft center (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1); and an expandable distal tip section (4) at the distal end of the elongate shaft (as shown in Fig. 8B), the expandable distal tip section comprising a collapsed delivery configuration (shown in Fig. 8A, see also [0105]), an expanded deployed configuration (shown in Fig. 8B, and also [0109]/[0110]/[0115]), a tip braid (see [0124]-[0125 and Figs. 8A-B), an expandable distal tip section center (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1), and a distal mouth comprising a beveled profile (62, Fig. 8B), wherein a profile of the expandable distal tip section is substantially symmetric with respect to the longitudinal axis when in the collapsed delivery configuration, but asymmetric or offset when in the expanded deployed configuration (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1) wherein in the expanded deployed configuration, at least a portion of the expandable distal tip section is longitudinally offset from the longitudinal axis, such that the expandable distal tip section center migrates radially away from being concentric with the proximal elongate shaft center (see Examiner’s Diagram of Figs. 8A/B above with respect to claim 1, the black vertical bars show the expandable distal tip section center and the proximal elongate shaft center, the proximal elongate shaft center is concentric with the long. axis (shown in dashed line) but the expandable distal tip section center is shown offset from the long. axis as it has migrated towards the left in Fig. 8B, thus it is longitudinally offset from the longitudinal axis because it has migrated radially away and is no longer concentric with the proximal elongate shaft center) in the same field of endeavor for the purpose of providing an askew distal end opening for providing advantages to guiding the clot engagement element into the expandable distal tip section while also allowing for an easier transition to the expanded configuration (see [0175]). It would have been obvious to one having ordinary skill in the art to have modified ‘186 patent claims 1 and 16 with the symmetric/asymmetric configurations taught by Gamba in order to provide an askew distal end opening for providing advantages to guiding the clot engagement element into the expandable distal tip section while also allowing for an easier transition to the expanded configuration.
Current dependent claims 2-15 and 17-19 are identical to ‘186 patent claims 2-15 and 17-19, as set forth in the table below.
Current application claim #
2
3
4
5
6
7
8
9
10
11
12
13
14
15
17
18
19
20
12,011,186 claim #
2
3
4
5
6
7
8
9
10
11
12
13
14
15
17
18
19
20
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive. As shown in the diagram below in addition to the Examiner’s diagrams above, Gamba meets the limitations of the newly added claim limitations in question, since the dashed box shown in the diagram below would correspond to the portion that is longitudinally offset in an analogous manner to Applicant’s “red box” shown in the annotated Fig. 6 at the top of page 8 of the arguments. Moreover, contrary to Applicant’s assertion, Fig. 8B as annotated clearly shows that the container element 4 is NOT symmetrical about the longitudinal axis, such that the center of the container element is not concentric with the center of the constraining catheter. This is shown by comparing the doubleheaded arrows which clearly show a different in the distance from the longitudinal axis to the radial boundary of the container element 4. Accordingly, Applicant’s arguments are not persuasive.
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Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771